UFS preparing protocol for clinical trial of Ivermectin for Covid-19

Request for study approval yet to be submitted

24 January 2021 - 14:58 By TimesLIVE
The SA Health Products Regulatory Authority has prohibited Ivermectin for human consumption. Stock photo.
The SA Health Products Regulatory Authority has prohibited Ivermectin for human consumption. Stock photo.
Image: 123rf/Jarun Ontakrai

The University of the Free State says it is in the process of preparing a clinical trial protocol to determine the efficacy of Ivermectin in the fight against Covid-19.

This is being handled by FARMOVS, a wholly-owned clinical research company of the university, together with several medical and scientific experts at the university.

The clinical trial protocol will be for a randomised, controlled study according to the requirements of the legal professions, to submit it for approval to the relevant national regulatory authority.

“By participating in the preparation of the clinical trial protocol, FARMOVS and the UFS remain supportive of and committed to contributing to the development of treatments and treatment strategies to battle the Covid-19 pandemic,” the university said in a statement.

“Should the clinical trial protocol be approved by the relevant national regulatory authority, the UFS will be the first university in SA to attempt such a study.”

The university statement comes as AfriForum said it had brought an urgent court application against the SA Health Products Regulatory Authority (SAHPRA) and Dr Zweli Mkhize, minister of health, to ensure that Ivermectin developed for human consumption is available to doctors who want to prescribe it to treat Covid-19.

SAHPRA has until now failed to approve applications by doctors — which were brought in terms of section 21 of the Medicines and Related Substances Act — to have Ivermectin approved for the treatment of Covid-19 patients.

AfriForum is asking in the court application, set to be heard next month, that:

  • The failure of SAHPRA to approve the section 21 applications be reviewed and set aside and that the court approve the section 21 applications;
  • A declaratory order that Ivermectin is a safe drug for the use of humans, subject to it being properly administered in a controlled manner under the management of a treating medical practitioner; and
  • A declaratory order that qualified medical doctors and pharmacists are entitled in terms of section 14(4) of the Medicines Act to compound medicine, on the prescription of a medical practitioner, which includes Ivermectin.

“We find ourselves in extraordinary circumstances. People die every day and health-care practitioners are inundated. Every day costs more lives. Under such circumstances the potential risks and benefits of a decision should be weighed with urgency, and actions should be decisive,” said Barend Uys, AfriForum’s head of research.

“Studies undertaken in, among others, the US, Argentina, India, Egypt and Spain all show that Ivermectin has the potential to treat Covid-19 and reduce deaths. The balance between risk and benefit is evident; this is why we are taking these steps to ensure its availability,” he said.

Meanwhile, UFS management distanced the institution from a WhatsApp voice clip being circulated, in which reference is made to a particular meeting, and mention is made of the role the institution is playing in establishing the efficacy of Ivermectin to treat Covid-19.

“The voice clip is premature and was shared with a small group, from where it went viral. The voice clip is also not factual — specifically regarding the university and its alleged opinion pertaining to the usage and need for scientific investigation into the matter.

“The UFS is committed to rigorous science and evidence-based research, and both FARMOVS and the university fully support the published opinions and guidelines of SAHPRA and the scientific advisory boards established by the scientific community, as well as the stance of the SA government on Ivermectin for Covid-19.”

TimesLIVE

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