By Gatonye Gathura
By the end of June, plans were underway for Kenya to host five clinical trials for the testing or development of Covid 19 drugs and vaccines.
Two of the studies are from the US, a similar number from the UK and one involving the World Health Organisation.
Last week the Kenya Medical Research Institute (Kemri) was considering a US funded proposal for a study on how the human immune system responds to a Covid 19 attack.
The information gained from the study, the protocol says can be used to “develop better Covid 19 tests, vaccines, treatments and prevention strategies.”
The study already recruiting participants in various sites in the US plans to start in Kenya, Tanzania, Mozambique, South Africa, Malawi, Botswana, Zambia, Zimbabwe, Argentina, Mexico and Peru.
“If approved, we will recruit Covid 19 patients at Jaramogi Oginga Odinga Teaching and Referral Hospital in Kisumu. We want to understand how the human immune system responds to an attack from the new virus,” said Dr Victor Mudhune of Kemri.
They will be recruiting patients in three groups; those who are asymptomatic, with mild illness and those with severe disease.
A second study registered with the US ClinicalTrials.gov No: NCT04372186 will also be tried in Kenya. The study will be evaluating the efficacy and safety of the arthritis drug tocilizumab (TCZ) in hospitalized patients with Covid 19.
Tocilizumab is manufactured by Genentech Inc, of the US a subsidiary of Roche Holding Ag, of Switzerland.
The trials which have already started in several sites in the United States will also be tested in South Africa, Maxico. Peru and at the Aga Khan University Hospital, Nairobi
This is the fifth Covid 19 foreign study Kenya has been invited to participate in starting with the World Health Organisation’s (WHO) Solidarity Trial in April.
The WHO study, ongoing in 35 countries is testing the effectiveness of several drugs including remdesivir, chloroquine, lopinavir + ritonavir, or with interferon-beta, against the virus.
Kenya’s Pharmacy and Poisons Board (PPB) has already approved the local Solidarity trial to be carried out at seven hospitals across the country.
The participating institutions include: Kenyatta National Hospital, Kilifi Kemri-Welcome, Coast General Hospital, Nairobi Hospital, Aga Khan University Hospital, Moi Teaching and Referral Hospital and Kenyatta University Teaching, Research and Referral Hospital.
However the applicants have indicated they are not expecting any major breakthrough from this study.
“It is not expected that any of the treatments currently being tested will have a large effect on the risk of death, but if any had just a moderate effect and was widely practicable then this could avoid large numbers of deaths,” they say in the application.
The third study involves testing of the Covid 19 vaccine candidate, ChAdOx1 nCoV-19 developed by University of Oxford of the UK.
The protocol registered in April and whose May start date has been significantly delayed targeted at recruiting 400 uninfected health workers in Kilifi County, Kenya.
“The protocol is still going through the regulatory approval process” said Kemri, the local collaborators.
Earlier in June the University of Oxford made a similar application to South Africa and already the exercise has already been rolled out.
Regulatory authorities in Kenya seem to be overly cautious in approving COVID 19 drug studies after in April President Uhuru Kenyatta said Kenyans would not be used as guinea pigs.
Immediately after, the National Commission for Science, Technology and Innovation (Nacosti), responsible for licensing of all research in the country – issued new guidelines for the licensing of Covid 19 human drug trials.
Significant, was a demand that any applicant must submit ‘full details of the proposed project including all the relevant research.’
Such an application must also have been approved by any of the 30 accredited institutional ethical review boards.
Additionally, Nacosti said for any clinical trials involving human subjects, applicants must also get approval from the Pharmacy and Poisons Board.
This may also mean getting the test drugs first registered with the board before they can be used on Kenyans.
Another study ISRCTN80453162 with sites all over the world including in Kenya is assessing how the COVID-19 coronavirus pandemic has changed the medical care of patients who have artery and vein problems.
Called COVER Study is sponsored by the University Hospitals Coventry and Warwickshire of the United Kingdom.