Lockdown diaries - COVID-19 matters!

What are you going to be doing during the lockdown?

  • At home. I’m non essential

    Votes: 70 41.2%
  • Working. The virus doesn’t scare me

    Votes: 41 24.1%
  • On standby

    Votes: 10 5.9%
  • Working from home. Too essential to take any risk!

    Votes: 66 38.8%

  • Total voters
    170
  • Poll closed .
Onchocerciasis

The origins of ivermectin as a human drug are inextricably linked with Onchocerciasis (or River Blindness), a chronic human filarial disease caused by infection with Onchocerca volvulus worms. The parasites are transmitted via the bite of infected blackflies of the genus Simulium, which breed in highly-oxygenated, fast-flowing rivers and watercourses. In the human body, immature larval forms of the parasite create nodules in subcutaneous tissue, where they mature into adult worms. After mating, female worms can release up to 1000 microfilariae a day for some 10–14 years. These move through the body, and when they die they cause a variety of conditions, including skin rashes, lesions, intense itching, oedema and skin depigmentation (Fig. (Fig.2 ).2 ). Microfilariae also invade the eye, causing visual impairment and loss of vision, onchocerciasis being the second leading cause of blindness caused by an infectious disease.17) The disease causes visual damage for some 1–2 million people, around half of who will become blind.18)

Figure 2.
Mali: an old man, blinded by onchocerciasis, with leopard skin on his legs and nodules on his abdomen. Credit line: WHO/TDR/Crump.
In the early-1970s, the disease was endemic in 34 countries: 27 in Africa; 6 in the Americas; and 1 in the Arabian Peninsula. The World Health Organization (WHO) later estimated that 17.7 million people were infected worldwide, of whom some 270,000 were blind, and another 500,000 severely visually disabled. The burden of onchocerciasis was particularly extreme in the hyper-endemic belt across sub-Saharan Africa. Communities in these areas exhibited high rates of visual disability caused by Onchocerciasis, up to 40% in some areas, which caused immeasurable negative impact on individual and community health, reducing economic capacity and productivity, and leading to the abandonment of fertile agricultural lands.19)
By 1973, Onchocerciasis had been recognised by the then head of the World Bank, Robert McNamara, as a major disease of massive health and socioeconomic importance and one in dire need of combating in West Africa, and he became the key agent for change. In 1974, following international recognition of the dramatic consequences of disabling and disfiguring Onchocerciasis in Africa, four United Nations agencies, including the World Bank, launched the Onchocerciasis Control Programme in West Africa (OCP). The programme covered 1.2 million km2, protecting 30 million people in 11 countries from River Blindness.
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Drug donation

For over a decade, OCP operations were exclusively based on the spraying of insecticides by helicopters and aircraft over the breeding sites of vector blackflies in order to kill their larvae. Following the registration of ivermectin (produced under the brand name Mectizan®) for human use in 1987, in a hitherto unprecedented move and with unheralded commitment, Mectizan® was donated by the manufacturing company, Merck & Co. Inc., to treat onchocerciasis in all endemic countries for as long as it was needed. The resultant drug donation programme was the first, largest, longest running and most successful of all—and proved a model for all others that have followed. Ivermectin began to be distributed in 1988, with operations being organized through the independent Mectizan Donation Program (MDP) established and funded by Merck. Thereafter, OCP control operations changed from exclusive vector control to larviciding combined with ivermectin treatment or, in some areas, to ivermectin treatment alone. Ivermectin swiftly became the drug of choice for the treatment of Onchocerciasis due to its unique and potent microfilaricidal effects, the absence of severe side effects and its excellent safety. It is now the sole tool being used in disease elimination campaigns in the 16 other African countries where the disease exists, orchestrated by the African Programme for Onchocerciasis Control (APOC), which commenced operations in 1996. A single annual dose of 150 µg/kg of ivermectin, given orally, can reduce the level of skin microfilariae to zero and, by interfering with worm embryogenesis, can delay the build-up of new microfilariae for a period of up to two years. OCP was closed in December 2002 after virtually stopping disease transmission in all target nations except Sierra Leone where operations were hampered by civil war.
The process, from the discovery of ivermectin’s activity against onchocercal microfilariae to the successful distribution programme from 1988 onward, was neither an easy or direct path. Success was achieved through groundbreaking and innovative partnerships. The journey was a complex undertaking, incorporating scientific uncertainty, conflicting views, ambiguity, frustration, individual innovation and unexpected twists and turns. The actual discovery of ivermectin was an international team effort involving a unique, pioneering Public Sector/Private Sector partnership and the commitment and vision of several key individuals. Ivermectin’s development into a drug for human use also involved a number of organizational, individual and pharmacological variables—together with a large slice of luck, educated insight and personal commitment.
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Development of ivermectin for human use

In the mid-1970s, the global community mobilized itself to address the major problems of neglected tropical diseases. Following the setting up of the OCP in 1974, the UN-based Special Programme for Research & Training in Tropical Diseases (TDR) was established in 1975.20) Onchocerciasis, one of two filarial infections among TDR’s eight target diseases, was at that time a major public health problem affecting 20–40 million people in endemic areas. At exactly this time, a specialized novel anthelmintic mouse screening model in Merck’s research laboratories was identifying the avermectins in the microbial sample sent by the Kitasato Institute, of which ivermectin would become the most successful derivative.
At the time, there were no safe and acceptable drugs available to treat Onchocerciasis, which had plagued Africa for centuries, effectively leading to the creation of the OCP and its vector control focus. TDR quickly found that, despite many pharmaceutical companies, such as Bayer, Hoffman-LaRoche, CIBA-Geigy and Rhône-Poulenc, carrying out routing screening for filaricidal compounds, no companies were interested in developing suitable anti-Onchocerca drugs, as there was no apparent commercial market. Worse still, Onchocerca species would not develop to maturity in any rodents, making it impossible to screen compounds in an animal model against the target organism.21) It had been shown that O. volvulus could infect chimpanzees (Pan troglodites) but it was deemed unethical to use these animals for the necessary large-scale research, even though some testing of compounds was undertaken.22,23) Consequently, the OCP opted to devote operations to aerial larviciding via helicopters and small fixed-wing planes. It was a very ‘vertical’ programme, mainly coordinated through the World Bank and other UN agencies, with multimillion dollar contracts given to a US-based helicopter company and to an American chemical company for the insecticides.
Meanwhile, with respect to research needs, TDR had identified six specific areas that required special attention, with the discovery of effective and safe chemotherapeutic agents considered to be the highest priority. In 1975, only two drugs were available for the treatment of onchocerciasis: diethylcarbamazine (DEC) and suramin. The use of both was highly unsatisfactory. DEC, which was known to kill microfilariae, caused violent and even dangerous hypersensitivity reactions in the human host. Suramin, developed 50 years previously for treatment of Sleeping Sickness, was the only drug considered for killing adult worms but was highly toxic, often causing severe and occasionally fatal reactions. Moreover, parasitological cure of patients using DEC and suramin required lengthy and expensive treatment given under medical supervision. Therefore, the TDR Scientific Working Group (SWG), composed of leading independent scientists in the field from around the globe, including industry, decided that the priority was a new and non-toxic macrofilaricide (to kill adult worms), a macrofilaricide being determined to be substantially preferable to a microfilaricide (which would target immature worms).24)
At the first meeting of TDR’s Filariasis Scientific Steering Committee in 1976, it was reported that Programme staff had visited 16 major pharmaceutical companies but had found none actively working on onchocerciasis. Nor was there any validated model for screening. The Committee agreed that the high cost of maintaining screening facilities for drugs against tropical diseases was a significant deterrent to industrial involvement.25) TDR acted to rectify this situation and thereby engage industry in the search for a new drug. Unfortunately, O. volvulus parasites can only develop fully in humans and a few primates. Fortunately, the closest relative to the human parasite is O. ochengi, found in cattle, which is restricted to Africa and which is also transmitted by the same vector. The O. ochengi cattle model thus facilitated experimental studies, in the field and laboratory-based, that were not possible in humans, leading to detailed knowledge of the parasite’s life cycle (Fig. (Fig.3 ).3 ). From 1977 on, TDR provided technical and financial support to establish a comprehensive screening system for Onchocercal filaricides. The Programme identified five academic and private research institutions with technical capacities and facilities for primary and secondary screens: the University of Georgia (USA), University of Giessen (Germany), the Wellcome Foundation (UK), the London School of Hygiene and Tropical Medicine (UK) and the University of Tokyo (Japan). TDR provided some US$2.25 million to these Public Sector institutions for primary and secondary screening of compounds, while pressing pharmaceutical companies to donate compounds for testing with the promise of full confidentiality. Additionally, TDR established a unique tertiary screen, using cattle, for compounds showing positive results in any secondary screen. Based at the James Cook University of North Queensland, Australia, the screen, costing almost US$435,000, was the best predictor of what a compound would do in humans. Some 10,000 compounds, many supplied by leading pharmaceutical companies as coded samples, passed through the screening network, including several from Merck.26)

Figure 3.
Life cycle of Onchocerca volvulus.
 
In reality, ivermectin’s role in human medicine effectively began in April 1978 inside the Merck company, several years before the drug emerged on the Animal Health market. The highly potent bioactivity of a fermentation broth of an organism isolated by the Kitasato Institute in Tokyo, which had been sent to Merck’s research laboratories in 1974, was first identified in 1975. The active compounds were identified by the international multidisciplinary collaborative team as the avermectins, with the subsequently-refined ivermectin derivative being designated the optimal compound for development. Merck scientists, under the direction of Dr William Campbell, found that the drug was active against a wide range of parasites of livestock and companion animals.10) The informed foresight of a Merck researcher, Ms. L.S. Blair, resulted in the discovery that the drug was effective against skin-dwelling microfilariae of Onchocerca cervicalis in horses. These did not actually cause clinical disease and so the finding was of little commercial significance. However, O. cervicalis belongs to the same genus as O. volvulus, and upon reading the experimental reports, Dr Campbell surmised that there might be some merit in testing for impact against the latter. In July 1978, he sent ivermectin (as a coded sample), together with the results of the horse trial, to the TDR-supported tertiary cattle screen in Australia. The results, obtained in November 1978, showed that ivermectin was “highly effective in preventing patent infections with both O. gibsoni and O. gutturosa”. This reinforced Campbell’s growing belief that ivermectin would be effective against human onchocerciasis. Consequently, in December, he proposed to the Merck Laboratories’ Research Management Council that “an avermectin could become the first means of preventing the blindness associated with onchocerciasis” and that “discussions be held with representatives of WHO to determine the most appropriate approach to the problem—from the medical, political and commercial points of view”.27,28) Senior management approved the lead taken by Campbell and research funding to investigate the potential use of ivermectin in humans was approved by Dr Roy Vagelos, then President of the research laboratories.
TDR reactions to the initial data about ivermectin were rather muted, especially as it was searching for a macrofilaricide and ivermectin appeared to have little impact on adult worms. In late-1979, a TDR official visited Merck and, although the meeting resulted in TDR’s technical contribution to Merck’s ivermectin research, there was no ensuing discussion about collaboration to develop ivermectin for use in human Onchocerciasis.
Fortunately for all, in January 1980, Merck decided to proceed independently to Phase I (safety) trials. Clinical trials of ivermectin began in 1981, with a Phase I trial in 32 patients in Senegal followed by another trial in Paris among 20 West African immigrants. These trials were independently organized and funded by Merck, with a staff member, Dr Mohamed Aziz, previously of WHO, being the caring and committed driving force behind them. Dr Aziz started the study in Senegal with safety uppermost in his mind. It began with a very low dose of 5 µg/kg and found that a single dose of ivermectin, 30 µg/kg, substantially decreased the number of skin microfilariae. It also established that the effect lasted for at least 6 months, with no serious adverse events being observed. The subsequent Paris study confirmed these results and showed that doses up to 200 µg/kg were well tolerated.29,30)
When Merck officials visited TDR and OCP in 1982 to present the results from the Phase I trials, each side recognised the immense potential and collaboration in earnest began.
Evidence suggests that collaboration between these major partners commenced in a complex environment of mutual wariness, suspicion and shared hope that ivermectin would indeed prove to be an effective treatment for Onchocerciasis. The situation was compounded by the fact that Merck saw ivermectin as a potentially commercial product to be used for individual patient treatment, and moved forward constantly seeking an income return on its investment. In contrast, TDR, together with OCP, saw the drug as a new community-level tool that could possibly interrupt parasite transmission and thereby help reduce the prevalence of the disease in endemic communities. TDR and OCP consequently regarded community-based trials under field conditions as an essential step towards mass-treatment programmes, as opposed to the individual treatment in hospitals favoured by the commercial partner. The continual negotiation with respect to the cost of the drug eventually resulted in a commitment from Merck in July 1985 to supply it in sufficient quantities and at the lowest possible price consistent with the interests of the company, later confirming that it would be made available to “… governments and patients at no cost to them for the treatment of Onchocerciasis”.31)
With respect to official registration of ivermectin for human use, Merck, focussing on the single-patient approach, pressed ahead on its own and submitted an application to the French health authorities in 1987 based solely on the studies of the first 1,206 onchocerciasis patients, expecting to receive approval later that year, which it subsequently did.24,32) In its submission, Merck indicated a price of $3 per tablet, meaning that a treatment dose would cost $6, well beyond an affordable amount for those most in need.
Prior to registration, the involvement of TDR and OCP increased substantially, as they organised field trials, including extremely expensive, large-scale trials of the effectiveness of ivermectin in community treatment programmes, and campaigned tirelessly to get the cost of treatment reduced to an acceptable level. During the trials to test the efficacy of the drug in field settings (Phase II trials starting in 1983), Merck continued to fund much of the work, with additional financial support from OCP and TDR. Fortunately, TDR’s existing international network facilitated Merck’s ability to develop workable relationships with researchers and institutions to conduct activities in Africa and South America. TDR was also able to influence the design of study protocols, and support applied research on onchocerciasis treatment at one of its specialized centres, the Onchocerciasis Chemotherapy Research Centre (OCRC) in Tamale, Ghana, where Dr Kwable Awadzi had devised a method to quantify clinical reactions to microfilaricides using a scoring system of commonly observed reactions.33) This made it possible to compare the degrees of systemic reactions for all compounds using a common metric, eventually confirming the promise of ivermectin as a safe and highly effective microfilaricide.
Thirteen community-level (Phase IV) trials were conducted between 1987–1989, with over 120,000 individual doses of ivermectin administered. Of the 13 community trials, TDR funded five in Liberia, Cameroon, Malawi, Guatemala and Nigeria, and spent US$2.35 million in total. Over the period, TDR spent between 25–35% of its total annual budget for all filariasis work on ivermectin. OCP funded the eight other studies in Ghana, Mali, Togo, Benin, Ivory Coast, Guinea, Burkina Faso and Senegal. As a private sector company, Merck’s financial contributions to the development of ivermectin for human use, although substantial, remain unknown.
 
New horizons

Ivermectin has continually proved to be astonishingly safe for human use. Indeed, it is such a safe drug, with minimal side effects, that it can be administered by non-medical staff and even illiterate individuals in remote rural communities, provided that they have had some very basic, appropriate training. This fact has helped contribute to the unsurpassed beneficial impact that the drug has had on human health and welfare around the globe, especially with regard to the campaign to fight Onchocerciasis.57)
Today, ivermectin is being increasingly used worldwide to combat other diseases in humans, such as Strongyloidiasis (which infects some 35 million each year), scabies (which causes 300 million cases annually), Pediculosis, Gnathostomiasis and Myiasis—and new and promising properties and uses for ivermectin and other avermectin derivatives are continuing to be found.58) These include activity against another neglected tropical disease, Leishmaniasis.59,60) Of perhaps even greater significance is the evidence that the use of ivermectin has both direct and indirect beneficial impact on improving community health. Studies of long-term treatment with ivermectin to control Onchocerciasis have shown that use of the drug is additionally associated with significant reduction in the prevalence of infection with any soil-transmitted helminth parasites (including Ascaris, Trichuris and hookworm), most or all of which are deemed to be major causes of the morbidity arising from poor childhood nutrition and growth.61) It is also known that the prevalence of head lice is markedly reduced in children taking ivermectin tablets62) and that scabies is markedly reduced in populations taking the drug regularly.63) Above all, ivermectin has proved to be a medicine of choice for the world’s rural poor. In many underprivileged communities throughout the tropics, intestinal worms and parasitic skin diseases are extremely common and associated with significant morbidity. They usually co-exist, with many individuals infected with both ecto- and endoparasites.64,65) Mass treatment of poly-parasitized populations is deemed to be the best means of control and ivermectin is the ideal drug for such interventions. A recent study in Brazil, using locally produced ivermectin, looked at the impact on internal helminthes and parasitic skin diseases. The researchers concluded that “mass treatment with ivermectin was an effective and safe means of reducing the prevalence of most of the parasitic diseases prevalent in a poor community in North-East Brazil. The effects of treatment lasted for a prolonged period of time”. This study also represented the first published report of human medical intervention using ivermectin that had not been produced by the hitherto traditional manufacturer, Merck & Co. Inc., the patent on the drug expiring in 1997.66)
In reality, the renewed interest in fighting tropical diseases, including the involvement of the pharmaceutical industry, which has become increasingly evident over the past three decades, and which has saved lives and improved the welfare of billions of people, notably the poor and disadvantaged in the topics, can be traced back to the 1987 introduction of ivermectin for use in humans. According to a recent report, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) data show that the global pharmaceutical industry provided over $9.2 billion in health interventions (medicines and equipment) between 2000–2007 alone, benefitting 1.75 billion people worldwide.67) The hitherto unprecedented donation of ivermectin in 1987 can rightly be seen to be the origin of this philanthropic outpouring.
Since the inception of the Mectizan Donation Programme, Merck has donated well over 2.5 billion Mectizan® tablets for Onchocerciasis treatment, with in excess of 700 million treatments authorised. Currently, some 80–90 million people are taking the drug annually through MDA in Africa, Latin America and Yemen. A further 300 million total treatments have been approved for lymphatic filariasis, with around 90 million treatments being administered annually (Fig. (Fig.8 ).8 ). At present 33 countries are receiving ivermectin for Onchocerciasis and 15 for Lymphatic filariasis. Consequently, around US$4 billion worth of ivermectin tablets have been donated to date. In 2010, Ecuador became the second country in the Americas to halt River Blindness transmission. It is hoped that transmission of the disease in the Western hemisphere will be stopped by 2012—a goal that will have been achieved thanks to twice-yearly MDA with ivermectin. Lymphatic filariasis is targeted for global elimination by 2020, and, if all goes well, Onchocerciasis may well be eliminated from Africa soon thereafter.

Figure 8.
Trend in ivermectin treatments approved (1988–2008).
It has, thus far, been a long and eventful journey from ivermectin’s origins in Japanese soil. Fortunately, and contrary to the position seen with most antibiotics, despite several decades of monotherapy and occasional suboptimal responses observed in some individuals, there is no conclusive evidence that drug resistance is developing in human Onchocercal parasites. Not surprisingly, public health specialists worldwide are now calling for greater and more extensive use of ivermectin,68) labelling MDA of the ‘wonder drug’ quite simply as “an underutilized public health strategy”. In response, the Kitasato Institute has initiated a global collaboration to investigate all properties and potential of a range of ivermectin analogues, both individually and in combination, particularly with a view to having a ready-made alternative should resistance to current ivermectin monotherapy ever threaten ongoing disease elimination campaigns.
 
Are their any medical doctors and or pharmacists on this forum to comment? ... I did a few pure science credits at varsity, (with the devious objective of meeting babes, so clearly my mind wasn't on chemistry), however, that was some 65536 years ago​
 
Is the active ingredient in Ivermectin effective in combating SARS-CoV-2? It could very well be, but I'm not a scientist or doctor.

Is it safe to buy a medicine specifically designed for use in animals, and that has known serious side effects in humans, over the counter and then self medicate with the guidance of a YouTube / Facebook video? NOT A EFFIN CHANCE

It might well be the "miracle" drug we are waiting for, but I'm not taking it as is.
View attachment 218534

The dosage most of the FB/YT gang suggests is that of cows at 1ml per 50kg of weight. An regurgitating feeder with 4 stomachs.... Yes, we are very anatomically similar.... :facepalm:
Broer I know people who took Bob Martin's religiously:icon_cafe: and they never ever went potty on the lawn
 
https://www.sahpra.org.za/news-and-...-in-the-prophylaxis-or-treatment-of-covid-19/

SAHPRA’S GUIDANCE ON THE USE OF IVERMECTIN IN THE PROPHYLAXIS OR TREATMENT OF COVID-19
in News & Updates, Press Releases
What is ivermectin?

Ivermectin is a widely used drug for the treatment and control of parasites in animals and is used to treat several tropical diseases in humans not commonly seen in South Africa, as well as scabies and head lice. Ivermectin is a synthetic derivative of the antiparasitic class of compounds known as avermectins.



In South Africa ivermectin is registered for use under Act 36 of 1947 (Department of Agriculture) for use in animals. This means that veterinarians and other trained personnel are allowed to prescribe it as an antiparasitic agent for a variety of animals. The drug is not currently registered for human use, but SAHPRA occasionally grants Section 21 permits for the use of topical ivermectin as an unregistered product for the treatment of individual patients with conditions such as scabies or head lice.



Several investigators have reported that when tested in the laboratory, ivermectin inhibits replication of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Given the current coronavirus disease-19 (COVID-19) pandemic, this has understandably received a lot of media attention. Thus, several clinical studies have been undertaken to evaluate ivermectin’s efficacy in treating the COVID-19 infection.



In some countries where ivermectin is registered for human use, the human use formulation is being used off-label in the management of Covid-19 infections where the clinical responsibility for monitoring of safety and efficacy lies solely with the prescriber. Furthermore, there are widespread reports of use of ivermectin for prophylaxis or treatment of COVID-19 in South Africa using the veterinary product.



SAHPRA’s view on the use of ivermectin communicated in December 2020

On the 22 December 2020, SAHPRA indicated that in relation to ivermectin use for COVID-19, that “Ivermectin is not indicated nor approved by SAHPRA for use in humans. There is no confirmatory data on ivermectin available as yet for its use in the management of COVID-19 infections. In terms of safety and efficacy there is no evidence to support the use of ivermectin and we do not have any clinical trial evidence to justify its use.



The Essential Medicines List (EML) COVID-19 Sub-committee Rapid Review on ivermectin (21 December 2020)

SAHPRA also notes that the EML COVID-19 Sub-committee published a Rapid Review on ivermectin (21 December2020) in which they similarly conclude that:

  • The overall quality of the randomized trials involving ivermectin in COVID‐19 patients is extremely low.
  • From the available randomized control trial evidence, ivermectin is not superior to placebo in terms of viral load reduction or clinical progression. There is no evidence from randomized control trials for any reduction in mortality.


Eligible patients with COVID‐19 in South Africa should be considered for enrolment in relevant therapeutic trials.



SAHPRA’s review of the current data on the use of ivermectin for the treatment or prophylaxis of COVID-19 infections

In response to this growing interest in ivermectin and the growing amount of data on its use in COVID-19 treatment and prevention, SAHPRA has now reviewed again, the available data from clinical studies.



A recent meta-analysis, i.e. systematic review, of the clinical trial data for the treatment of COVID-19 has been conducted by Dr Andrew Hill of the University of Liverpool, sponsored by Unitaid which is a global health initiative that works with partners to bring about innovations to prevent, diagnose and treat major diseases in low- and middle-income countries). Although this report is widely available publicly, it has not yet been published in a peer-reviewed scientific journal.



The meta-analysis concluded that the use of ivermectin in the management of COVID-19 infections is associated with faster time to viral clearance, shorter duration of hospitalisation and higher rates of clinical recovery and some improvement in survival rates.



However, the meta-analysis also concluded that additional randomized clinical trial data were needed to confirm clinical benefit in COVID-19 infections as well as define an optimized dosing regimen. Furthermore, Dr Hill identified a number of limitations with the data from these clinical trials, including that:

  • Current results are based on limited randomised trials
  • There is potential for publication bias
  • The individual trials reviewed had limited statistical power
  • Several trials were open-label presenting a potential for investigator bias
  • Range of doses and durations were not standardised
  • Endpoints differed between trials


In his conclusion, Dr Hill indicated that well designed clinical trials are required to provide sufficient scientific data for the use of ivermectin for the treatment of COVID-19.



Based on the Hill meta-analysis and the Front Line COVID-19 Critical Care Alliance (FLCCC), SAHPRA notes the following:

  • The overall quality of the randomized clinical trials involving ivermectin in COVID‐19 patients is poor and underpowered. From the available randomized control trial evidence, ivermectin appears not to be superior to placebo in terms of viral load reduction or clinical progression. There is no evidence from randomized controlled trials for any reduction in mortality.
  • The studies vary with respect to the population groups included in the studies i.e. out-patients, early hospitalizations, patients with longer duration hospitalizations, patients in ICU etc.
  • The dosages in the various studies are not uniform. As a result, dose-finding cannot be established for the safe and effective management of COVID-19 infections (whether it is for treatment or prophylaxis).
  • Ivermectin has been trialed with several other concomitant medicines (proven and unproven, either alone or in combination with other medicines) and this limits the conclusions that can be made about ivermectin’s safety and efficacy.
  • These studies have further limitations that have been identified by the reviewers themselves as indicated above, the most notable being that not enough trial data is currently available. But it is noted that there will be further clinical data available by mid-to-end January 2021. SAHPRA eagerly awaits this information in order to review its stance on the use of ivermectin in the management of Covid-19 infections.


SAHPRA notes that to date, there have been no positive recommendations for the use of ivermectin in the management of Covid-19 infections by any regulatory authority with which SAHPRA has reliance agreements, e.g. USFDA, EMA, MHRA, etc., and that the WHO does not currently recommend the use of ivermectin for the treatment or prophylaxis of COVID-19 infections.



Furthermore, a report on the pharmacokinetics of ivermectin concluded that ‘Preliminary findings suggest that standard doses of ivermectin would not result in efficacious concentrations, and that extraordinary doses to achieve efficacious concentrations may result in unacceptable toxicity in COVID-19 patients.’ (Ref: Pharmacometrics Africa and CERTARA).



It is also important to note that while ivermectin is considered generally safe, side-effects include skin rash, nausea, vomiting, diarrhoea, stomach pain, facial or limb swelling, neurologic adverse events (dizziness, seizures, and confusion), sudden drop in blood pressure, severe skin rash potentially requiring hospitalization and liver injury (hepatitis). Laboratory test abnormalities include decrease in white cell count and elevated liver tests.



Current status of applications to SAHPRA for clinical trial approval or for registration

At present, no ivermectin clinical trial applications have been submitted to SAHPRA for review. SAHPRA encourages the submission of clinical trial applications designed to establish the safety and efficacy of ivermectin in the management of Covid-19 infections for both treatment and prophylaxis and commits to expediting their review. This approach has previously been applied to clinical trial applications for other investigational medicines that were being evaluated for COVID-19 management.

In addition, SAHPRA has received no applications to register ivermectin for either prophylaxis or treatment of COVID-19 but commits to fast track the review of any such application should this be submitted.



Conclusion

There are currently no applications either for clinical trials or for the registration of ivermectin for the treatment or as prophylaxis for COVID-19. However, SAHPRA encourages and supports all well- designed, ethically approved, scientific studies designed to identify new or existing medicines that are used for the treatment or prophylaxis of COVID-19. SAHPRA reiterates its commitment to expedite the review of such studies. Furthermore, as the South African regulatory authority, SAHPRA will continue to evaluate any emerging peer reviewed publications or data on the use of ivermectin for the treatment of COVID-19, and notes that according to the global clinical trials register, additional data should become available in the course of the next few months. SAHPRA will also consider enabling access to approved formulations of ivermectin intended for human use, including through Section 21 authorisation, provided such a request is supported by evidence for the indication requested and is justified based on a risk benefit assessment that includes safety and clinical efficacy data.
 


Like I said:
"Is the active ingredient in Ivermectin effective in combating SARS-CoV-2? It could very well be, but I'm not a scientist or doctor.

Is it safe to buy a medicine specifically designed for use in animals, and that has known serious side effects in humans, over the counter and then self medicate with the guidance of a YouTube / Facebook video? NOT A EFFIN CHANCE

It might well be the "miracle" drug we are waiting for, but I'm not taking it as is."



The Ivermectin the good Doc Kory is referring to is a tablet, manufactured for human consumption by a pharmaceutical company. And as he himself states in the video above, the animal grade Ivermectin that people are glorifying on FB/YT have high levels of impurities, and he himself does not recommend taking it. As it was designed for animal use.

I know Penicillin is great, but I'm not licking mould off a stick.....
 
Don't get me wrong @Alex, I'm not knocking Ivermectin. Just as most doctors I know and @GrandGuru. I'm concerned about ill informed people, taking a version of the drug, that was never intended to be consumed by humans, based on some YT/FB viral videos (that ironically spread faster than the actual virus)
 
Like I said:
"Is the active ingredient in Ivermectin effective in combating SARS-CoV-2? It could very well be, but I'm not a scientist or doctor.

Is it safe to buy a medicine specifically designed for use in animals, and that has known serious side effects in humans, over the counter and then self medicate with the guidance of a YouTube / Facebook video? NOT A EFFIN CHANCE

It might well be the "miracle" drug we are waiting for, but I'm not taking it as is."



The Ivermectin the good Doc Kory is referring to is a tablet, manufactured for human consumption by a pharmaceutical company. And as he himself states in the video above, the animal grade Ivermectin that people are glorifying on FB/YT have high levels of impurities, and he himself does not recommend taking it. As it was designed for animal use.

I know Penicillin is great, but I'm not licking mould off a stick.....

I suddenly crave blue cheese:facepalm:
 
Don't get me wrong @Alex, I'm not knocking Ivermectin. Just as most doctors I know and @GrandGuru. I'm concerned about ill informed people, taking a version of the drug, that was never intended to be consumed by humans, based on some YT/FB viral videos (that ironically spread faster than the actual virus)
I would hope someone analyse past data and lead a study into new findings. If this is the thing we all want to avoid, but might have usefull answers regarding covid19 (+20-21) +mutations then they should stop arguing and figure out how to make it work.???
 
I'm all for a miracle cure/working vaccine. And I'm 1000% sure SWAMBO and her team, and Healthcare workers globally, are also hoping and praying for a miracle cure. We lost another 4 people in town today. Since 22 December, we have been between 2-5 people on a daily basis, 1on the good days, but not none. The Healthcare workers are tired, physically and emotionally drained. We all want this to end (except maybe government) and to return to normality (or what is left of it)
 
I'm all for a miracle cure/working vaccine. And I'm 1000% sure SWAMBO and her team, and Healthcare workers globally, are also hoping and praying for a miracle cure. We lost another 4 people in town today. Since 22 December, we have been between 2-5 people on a daily basis, 1on the good days, but not none. The Healthcare workers are tired, physically and emotionally drained. We all want this to end (except maybe government) and to return to normality (or what is left of it)
This makes me think of all that's been said about vaping, but I still do it. Why because I smoked (leaving out all the details why and how) yet I vape and it's still being said it's not tried and tested or anyBODY approved.
If there's something that can come out from this then why shouldn't the Body corporates persue this idea of medicine that's been used but not approved because it's only going to get used in animals and a derivative in very poor humans in parts of the world that most people wouldn't care for.(and no millions to be made because it's already registered and patented.
 
Ivermectin is not a new medicine. It’s been on the market for decades used for the treatment of intestinal worms, lice and mite etc. It’s an anti parasitic drug approved for human use as well.
The issue that I raised is that tests have failed to prove its efficacy in preventing viral replication at those small concentrations where it’s still safe for human use...
You can paste several articles and YouTube videos praising its role in the treatment of COVID-19 (same as with the hydroxychloroquine by the way) and I will paste a similar number of links to articles (scientific) that prove the opposite (or claim to at least).
I believe people have the right to the treatment of their choice! But I also believe that they shouldn’t be left alone to self prescribe and medicate without minimal expert advice....
Times are hard and testing not only our patience but also our intelligence so let us prove to be a bit smarter than our grand fathers who caused a massacre during the Spanish flu.
 
So what would happen if they combine (obviously in a lab with medical staff orchestrating) the 11official vaccines?
 
See, this is what worries me:
Screenshot_20210106_223953_com.android.chrome.jpg

3 different types of Ivomec, all sold out. I can almost bet you that was not the case a few days ago.
3 different solutions
1% Ivermectin
3.5% Ivermectin
1% Ivermectin + 10% Clorsulon

Almost all of these FB/YT videos don't specify which one to take. Dosage on each package is the same 1ml per 50kg body mass. Joe Public has no clue which one is which, they just know the Doctor on the video said Ivermectin and here in SA we get it as Ivomec.
Any guesses on the safety of Clorsulon for human consumption?

https://parasitipedia.net/index.php?option=com_content&view=article&id=2716&Itemid=2966
 
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So what would happen if they combine (obviously in a lab with medical staff orchestrating) the 11official vaccines?
Big Pharma loses money and will have to create and spread a mutant virus to create new business opportunities.... No buddy, don’t go there. I was suggesting we be a bit smarter than our grand parents but not too smart either :p
 
See, this is what worries me:
View attachment 218536

3 different types of Ivomec, all sold out. I can almost bet you that was not the case a few days ago.
3 different solutions
1% Ivermectin
3.5% Ivermectin
1% Ivermectin + 10% Clorsulon

Almost all of these FB/YT videos don't specify which one to take. Dosage on each package is the same 1ml per 50kg body mass. Joe Public has no clue which one is which, they just know the Doctor on the video said Ivermectin and here in SA we get it as Ivomec.
Any guesses on the safety of Clorsulon for human consumption?

https://parasitipedia.net/index.php?option=com_content&view=article&id=2716&Itemid=2966
Oh snot. Now you going to get stories about vaping ivermectin.:facepalm:
 
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