Local scientists eye clinical trial of Ivermectin
Agroup of local scientists and doctors is in talks with the Ministry of Health and Wellness on the possibility of launching a clinical trial for the use of Ivermectin to treat COVID-19.
The drug, used for parasitic infections and locally in the veterinary health sector, has divided the global scientific community as a treatment for COVID-19 due largely to absence of authoritative studies.
With local cases of the pandemic shooting up and healthcare facilities reaching their limits, pressure is mounting on Botswana to establish its own study on the drug’s potential to treat the virus. As Botswana and other African countries remain at the back of the global queue for COVID-19 vaccines, attention is shifting to the search for treatment options for the virus.
Dr Gaonyadiwe Mokone, a founding member of the Botswana COVID-19 Ivermectin Intervention Group (BCIIG) told Mmegi that discussions are ongoing with the Health Ministry towards supporting a local clinical trial to establish whether Ivermectin can be used in treating COVID-19. “The elephant in the room is funding because clinical trials are very expensive,” he said yesterday.
“We are still talking to the Ministry about that. “They are waiting for our proposal to assess the budget and other considerations. We don’t know whether they will be able to cover it all.”
Last week, the Ministry’s permanent secretary, Grace Muzila gave BCIIG the go ahead to put together a proposal on the matter noting that the decision had come after “intense deliberations” within government.
“MoHW has resolved that BCIIG should come up with a proposal for use of Ivermectin under clinical studies,” she said in a letter.
“This is also in line with World Health Organisation current recommendations that Ivermectin can be used in humans only under clinic trials.” Muzila said the ministry appreciated the efforts made by “our own citizens” in identifying gaps in the healthcare system and going further to find solutions.
Mokone told Mmegi that a clinical trial would involve monitoring of patients and other scientific protocols as part of the study, as opposed to doctors prescribing the drug to patients. The BCIIG’s 20 members believe that while local evidence is important to establish Ivermectin’s potential, the totality of evidence from studies undertaken elsewhere in the world suggest the drug can help reduce deaths from the virus.
“The research shows that there’s a moderate level of certainty of evidence that this drug can reduce the death rate,” Mokone told Mmegi.
“We are saying in the context of a pandemic that it is killing within days, as a government you should be considering that the drug ought to be considered in the technical management of COVID-19.”
He said while 32 randomised studies of Ivermectin’s use for COVID-19 had been conducted globally, the common criticisms include that the samples were small or the studies were not totally blind, meaning the patients or their doctors, or both were not informed they were taking the drug. “Scientists are divided in the country and globally, with some saying the studies done so far are adequate, while others say they are not.
“For us an advocacy group, we were advising that look at the evidence we have gathered that others have generated. “We are just people trying to help our country help our people.”
Meanwhile, the Botswana Medicines Regulatory Authority (BoMRA) said it has never taken a position on the use of Ivermectin for COVID-19 treatment, but rather cautioned the public about the use of veterinary Ivermectin as it is not intended for human use. The regulator further said thus far, it had not been asked to study any proposal for the use of Ivermectin for prevention or treatment of COVID-19 infection.
“A group of doctors approached BoMRA seeking information on registration of Ivermectin for use in human beings and they were briefed on the registration process and procedures involved in the registration of any medicine for use in Botswana,” BoMRA information officer, Mbaakanyi Macheke told Mmegi.
He added: “For researchers and scientists who wish to study the use of Ivermectin, they have to follow a clinical trial path.
“Essentially they are expected to develop a clinical trial protocol and submit to BoMRA seeking approval of the trial protocol.
“On approval of the study protocol, they will subsequently be allowed to import Ivermectin for specific use in COVID-19 infections only on clinical trial mode.”