The University of the Free State will commence clinical trials to determine the efficacy of Ivermectin as a treatment for the symptoms of COVID-19. FARMOVS, the university’s clinical research company, will take charge of the trials.
The randomised controlled study will comply with all legal requirements in order to submit it to the relevant national regulatory authority – the South African Health Products Regulatory Authority (SAHPRA).
UFS’ announcement comes on the heels of SAHPRA stating that it would revisit research that suggests that Ivermectin is a viable treatment for the symptoms of COVID-19 once more data becomes available.
SAHPRA bemoaned the poor quality of the randomised clinical trials involving Ivermectin in COVID-19 patients. The regulator further stated that it had received no clinical trial or registration applications but it would fast-track any such applications if and when they are submitted.
However, SAHPRA said it has received several Section 21 applications. These applications are used to request authorisation to sell unregistered medicine.
“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,” said UFS.
“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.”
Afrikaner lobby group, AfriForum, presented an urgent court application against SAHPRA and the Minister of Health Dr Zweli Mkhize regarding Ivermectin.
The group wants to ensure that Ivermectin developed for human consumption is readily available to doctors who want to prescribe the drug, which is a parasitic agent, as a treatment for 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,” said AfriForum.
Picture: Pixabay – unrelated
