Kenya has approved the testing of experimental Covid 19 antibody treatments on none hospitalized patients.
The Pharmacy and Poisons Board has approved an open-ended platform that allows experimental Covid 19 drugs to be tested in the country as they become available.
“The platform will allow investigational agents to be added and dropped during the course of the study as new agents become available,” says the board.
The choice of trial drugs, the board says will be identified by agents of the US National Institutes of Health who are sponsoring the trials.
Normally approved applications for human drug trials will clearly identify by name the products being tested including where possible the proposed dosages. But the current approval does not name or identify the drugs to be tested.
However, a casual search shows the Kenyan study called – Adaptive Platform Treatment Trial for Outpatients with COVID-19 or Adapt Out COVID – is an extension of similar trials going on in the US by the same name.
The US study, ‘ClinicalTrials.gov Identifier No: NCT04518410’ is also planned for Argentina, Brazil, Canada, Philippines, Puerto Rico, and South Africa, targeting 2,000 Covid 19 positive outpatients.
However, in this study trial drugs including proposed dosages are clearly named. These include Bamlanivimab by Eli Lilly pharmaceutical company of US, BRII-196, and BRII-198 by Brii Biosciences of China, SAB-185 by SAB Biotherapeutics of US, and AstraZeneca’s cilgavimab and tixagevimab.
These are relatively new experimental Covid 19 treatments known as antibody therapies. They are mainly derived from the blood plasma of persons previously infected with Covid 19 or factory manufactured.
An example is Regeneron’s therapy which was used to treat former US President Donald Trump for Covid 19 last year.
Back to Kenya, the approved study will initially target 200 volunteers with half getting the active drug and the rest a placebo. The overall target is 850 adult volunteers for each investigational product.
Once the site enrolls the initial sample of 200, the approval says it will continue to enroll more participants as long as there are new drugs or other Covid-19 treatment products being developed that require testing.
The study will be carried out by Kenya Medical Research Institute in Kisumu, the US Army Walter Reed Center, Kericho, and Moi University Clinical Research Centre in Uasin Gishu County.
Interestingly the study will be led by Dr Kawango Agot of the Kenya Impact and Research Development Organization, an NGO based in Kisumu.
The choice of the NGO to lead the study instead of Kemri, a national research organization may reflect ongoing tensions between the latter and some US government agencies.
For example, the US Centers for Disease Control and Prevention-Nairobi is in the process of disengaging from Kemri for a new agency to be known as the Kenya Centers for Disease Control (KCDC).
By Gatonye Gathura