The efficacy clinical trial by the Univerity of the Free State has been welcomed by Doctors Interest Group.
Durban – Doctors in the Ivermectin Interest Group (IIG) have welcomed the University of the Free State’s (UFS) decision to conduct a clinical trial protocol to determine the efficacy of ivermectin for the treatment of Covid-19.
But the group have cautioned that in many countries double blind placebo controlled trials would be considered unethical because of the considerable number of people that would die unnecessarily to confirm what was “most likely to become a known fact”.
UFS announced in a statement at the weekend that FARMOVS, its wholly owned clinical research company, together with several medical and scientific experts at the university, was preparing a clinical trial protocol to determine the efficacy of ivermectin for Covid-19 in a randomised, controlled study according to the requirements of the legal profession, in order to submit it for approval to the relevant national regulatory authority.
FARMOVS is a South African speciality full-service clinical research organisation, that conducts ICH-GCP-compliant phase I to IV clinical trials. It has the only on-site International Organisation for Standardisation (ISO) and Good Laboratory Practice (GLP) certified bio-analytical laboratory on the continent.
“Should the clinical trial protocol be approved by the relevant national regulatory authority, the UFS will be the first university in South Africa to attempt such a study,” the UFS said.
However, the university said a WhatsApp message that had been circulating about the university’s role was not factual.
“The university management is aware of 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 for Covid-19. The voice clip is premature and was shared with a small group, from where it went viral,” the UFS said.
“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 said.
“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 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 for Covid-19,” the university said.
IIG group member University of KZN Professor Colleen Aldous said there were still some questions about the use of ivermectin for Covid-19 that only rigorous clinical trials could answer.
Aldous said the infrastructure offered by FARMOVS would smooth the way for a quality clinical trial of ivermectin in Covid-19 patients that should satisfy the critics of the trials already completed across the globe.
“The main criticisms of current studies have been small sample size and poor study design. With their resources, FARMOVS should be able to set up the trial soon enough to be of benefit to South Africans before the anticipated third wave in May,” Aldous said.
“The trials that have already been published worldwide on ivermectin use in Covid-19 cases should inform this new trial with regard to dose-response and appropriate outcome measures in the three-tier hospital system we have in South Africa. While many trials are currently being run in other countries, this particular study will be carried out in the South African context,” she said.
She said questions such as rollout logistics and tolerability in the health services setting could add important information.
“What is of personal interest to me is whether they will take on a double-blinded randomised control trial design when Dr Andrew Hill’s (of the University of Liverpool) meta-analysis of completed studies of Ivermectin in Covid 19 treatment already shows from 17 clinical trials across the globe that the mortality has an average reduction of 75% (CI 48% – 83%),” she said.
Ear, nose and throat specialist Dr Martin Gill, also an IIG member, noted that Hill had indicated that “double-blind placebo controlled trials would not be considered ethical in most countries, because of the considerable number of people that would die unnecessarily, to confirm what is most likely to become a known fact”.
Health Minister Zweli Mkhize’s spokesperson Popo Maja said the department did not have sufficient information to comment on the trial yet.