By Sharon Atieno
As COVID-19 cases continue to claim more lives, it is critical to treat mild cases to halt progression to severe disease and prevent hospitalizations. As such, 13 African countries and an international network of research institutions have joined forces to launch the largest COVID-19 clinical trial in mild-to-moderate outpatients in Africa.
The clinical trial to identify early treatments that can prevent progression of COVID-19 to severe disease and potentially limit transmission will be carried out at 19 sites in 13 countries by the ANTICOV consortium, which includes 26 prominent African and global research and development (R&D) organizations, coordinated by the Drugs for Neglected Diseases initiative (DNDi), an international non-profit drug research and development (R&D) group.
The trial will test the safety and efficacy of treatments in 2,000 to 3,000 mild-to-moderate COVID-19 patients in Burkina Faso, Cameroon, Côte d’Ivoire, the Democratic Republic of Congo (DRC), Equatorial Guinea, Ethiopia, Ghana, Guinea, Kenya, Mali, Mozambique, Sudan, and Uganda.
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 an ongoing analysis of results.
New treatments will be added to the trial as evidence of their potential for mild-to-moderate cases emerges.
ANTICOV researchers are actively looking to select the most promising treatments from ongoing global scientific efforts with proof of efficacy, in collaboration with the Access to COVID-19 Tools Accelerator (ACT-A) Therapeutics Partnership, co-convened by Unitaid and Wellcome on behalf of the COVID-19 Therapeutics Accelerator.
Among the potential therapeutic options being explored by ANTICOV are medicines currently used to treat malaria, HIV, hepatitis C, parasitic infections, and certain cancers. The goal is to include additional treatment arms in the ANTICOV trial within weeks.
Initially, ANTICOV will focus on drugs where large-scale randomized 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 the standard of care for COVID-19 today in numerous African countries.
Major funding for the ANTICOV consortium is provided by the German Federal Ministry of Education and Research (BMBF) through KfW and by the global health agency Unitaid as part of ACT-A. Early support to launch the initiative was provided by the European & Developing Countries Clinical Trials Partnership (EDCTP), under its second programme supported by the European Union with additional funding from the Swedish government, and the Starr International Foundation, Switzerland.