As the debate rages on about whether Ivermectin should be authorised to be prescribed as Covid-19 treatment, the University of the Free State (UFS) has announced it is in the process of preparing a clinical trial to determine the efficacy of the drugs.
The university, through its specialty full-service clinical research company FARMOVS, said “together with several medical and scientific experts at the institution, is currently in the process of preparing a clinical trial protocol to determine the efficacy of Ivermectin for Covid-19.
According to the university’s website, this will be a randomised, controlled study according to the requirements of the legal professions, in order to submit it for approval to the relevant national regulatory authority.
This comes on the back of an impassioned letter and a petition signed by a group of doctors appealing to President Cyril Ramaphosa to seriously review the current ban on the use of the drug as the new variant of Covid-19 continues to wreak havoc in the country.
Although South African Health Products Regulatory Authority (SAHRPA) initially issued a warning prohibiting the public and doctors from using the drug, reports suggest the body is re-thinking its initial stance after it asked for more details before it can authorise trials. Critics of Ivermectin point to the fact that the drug cannot be re-purposed for human use without being subjected to strict and controlled medical studies and other related protocols.
FARMOVS also has the capacity to conduct complex and highly specialised clinical trials including ICH-GCP-compliant Phase I to IV clinical trials. According to the UFS, FARMOVS’ competitive advantage is its wealth of bio-equivalence and Phase I experience and expertise, patient recruitment success. In addition, it is a clinical research facility with the only onsite international Organisation for Standardisation (ISO) and Good Laboratory Practice (GLP) certified bio-analytical laboratory on the African continent.
The UFS said its participation in the preparation of the clinical trial protocol, should be seen as supportive to and a commitment to contributing to the development of treatment and other related strategies aimed to deal with the Covid-19 pandemic. The UFS will be the first university in South Africa to attempt such a study, if the clinical trial protocol is approved by the relevant national regulatory authority.
The university said it is committed to rigorous science and evidence-based research, and both FARMOVS and the university fully support the published opinions and guidelines of the SAHPRA. This includes the scientific advisory boards established by the scientific community, as well as the stance of the South African government on Ivermectin for COVID-19.