- UFS is applying to test ivermectin for human use against Covid-19
- Should the institution be granted approval, it will be the first in the country to conduct a trial of this nature
- Sahpra welcomes the trial
The University of the Free State (UFS) is in the process of preparing a clinical trial protocol to examine the efficacy of ivermectin as a treatment for Covid-19, according to a statement by the institution.
The clinical study will be done by the university’s clinical trial arm called FARMOVS. The institution has a wealth of experience in conducting trials on vaccines, diabetes and heart-related matters.
If the UFS gets approval to test the efficacy of ivermectin on Covid-19 in humans, it will be the first university in South Africa to launch such a study. The institution has vast experience in conducting phase one trials, and the capacity to conduct phase one to four trials.
“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 statement reads.
UFS says that it aims to contribute to the science and development of treatments against the virus. The institution says that it fully supports the published opinions and guidelines of the South African Health Products Regulatory Authority (Sahpra) and the scientific advisory boards established by the scientific community, as well as the stance of the South African government on ivermectin against Covid-19.
The trial will need approval from Sahpra’s clinical trial unit. According to the regulatory body’s website, the unit aims to process new applications and issue a checklist within three weeks of receiving the application.
Recommendations from the trial would be sent within 10 weeks of submission due date. In some instances, the turnaround time may take longer if it is an unfamiliar product, and may need to be referred to external reviewers or other committees of Sahpra for input.
Sahpra also says it may take about six weeks after the submission of the application for additional investigators, site(s) and protocol amendment.
The organisation’s spokesperson Yuven Gounden tells Health24 that the body welcomes any new data.
In a previous statement, Sahpra said that it 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. It is committed to expedite the review of such studies.
“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,” the statement reads.