An ambitious African study to identify treatments that can be used to treat mild and moderate cases of coronavirus patients early has been launched.
The clinical trial, which targets 13 African countries, also seeks to prevent spikes in hospitalisation that could overwhelm fragile and already overburdened health systems in Africa. The continent has recorded about 2.1 million cases and more than 50,000 deaths.
According to Drugs for Neglected Diseases initiative (DNDi), an international non-profit drug research and development (R&D), the investigation will be carried out at 19 sites in 13 countries by the ANTICOV consortium which is part of the World Health Organisation’s (WHO) solidarity trial to find an effective treatment for Covid-19. The Solidarity trial is one of the largest international randomised trials. The clinical trial aims to identify a treatment or two treatments that could be used to treat mild and moderate cases of Covid-19, to stop the disease from getting more serious.
The study comes at a time when three multinational pharmaceutical companies Pfizer/BioNTech, Oxford/Astrazeneca, and Moderna announced promising results about the ongoing clinical trials for a Covid-19 vaccine. Compared to Pfizer and Moderna’s vaccine that require a storage temperature as low as -70 degrees Celsius, a logistical nightmare for many African countries, Astrazeneca’s AZD1222 vaccine “can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius) for at least six months and administered within existing healthcare settings.”
ANTICOV is an adaptive platform trial, an innovative type of clinical trial pioneered for cancer drugs that allows for several treatments to be simultaneously tested. Adaptive platform trials enable rapid decisions to be made, including adding, continuing, or stopping treatment arms based on ongoing analysis of results.
“There is a need for large clinical trials in Africa for Covid-19 to answer research questions that are specific to an African context,” said Dr John Nkengasong, director of the Africa Centres for Disease Control and Prevention.
The study will test the efficacy of treatments in 2,000 to 3,000 mild-to-moderate patients in Burkina Faso, Cameroon, Ivory Coast, the Democratic Republic of the Congo, Equatorial Guinea, Ethiopia, Ghana, Guinea, Kenya, Mali, Mozambique, Sudan, and Uganda, with the goal of identifying treatments that can prevent progression of coronavirus to severe disease and also limit transmission.
“African countries have mounted an impressive response so far to Covid-19 and now is the time to prepare for future waves of the disease. We welcome the ANTICOV trial led by African doctors because it will help answer one of our most pressing questions: With limited intensive care facilities in Africa, can we treat people for Covid-19 earlier and stop our hospitals from being overwhelmed?” added Dr Nkengasong.
Initially, ANTICOV will focus on drugs where large-scale randomised clinical trials could provide missing efficacy data in mild-to-moderate patients. The trial will begin testing, against a control arm, the HIV antiretroviral combination lopinavir/ritonavir and the malaria drug hydroxychloroquine, which remains as a standard of care for Covid-19 in many African countries.
A study carried out early this month by a major US research centre, however, found that Hydroxychloroquine does not benefit adults hospitalised with Covid-19. The National Institutes of Health (NIH) study sought to test whether the malaria and arthritis drug works to treat coronavirus.
“It is heartening to see so many African countries collaborate to get much-needed answers about our unique Covid-19 patient needs,” said Dr Borna Nyaoke-Anoke, a Senior Clinical Project Manager at DNDi, which is also sponsoring clinical trials in the DRC, Kenya, and Sudan.