DNDi and its partners will launch a 13 country clinical trial in Africa (including Uganda) for mild cases of COVID-19 – this will be the largest effort of its kind in Africa, and dovetails with a marked increase in cases in plenty of countries on the continent.
Treating mild cases is key in Africa because ICU capacity is not as strong as may be in other developed nations. All eyes are now turned to vaccines, but vaccines alone won’t be enough to stop the pandemic and save lives. Treatments are just as important.
The goal of this trial, which is named ANTICOV is to identify treatments that prevent mild cases from progressing to severe forms of the disease – and thus prevent local health systems from being overwhelmed.
ANTICOV could be compared to SOLIDARITY, but while the SOLIDARITY trial deals focus on severe cases), ANTICOV focuses on mild cases. It is an adaptive platform trial so researchers can add new treatments as the trial moves on or remove treatments deemed not to be effective as it moves forward.
Hydroxychloroquine will be one of the drugs to be studied initially because there are no large multi-country studies yet about the efficacy of the drug for mild cases. HCQ remains the standard of care for COVID in 16 African countries, so this trial will provide key evidence to inform health policies and national guidelines.
The clinical trial 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 with extensive partnerships in Africa.
“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. “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?”
ANTICOV is an open-label, randomized, comparative, ‘adaptive platform trial’ that 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 aims to identify early treatments that can prevent the progression of COVID-19 to severe disease and potentially limit transmission.
“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, Senior Clinical Project Manager at DNDi, which is also the sponsor for clinical trials in the DRC, Kenya, and Sudan.
“Africa has for the most part avoided the large-scale mortality seen in other countries, but with lockdowns ending and borders opening, we need to be prepared. We need research here in Africa that will inform policies and test-and-treat strategies so that as clinicians we can give the best options to people with COVID-19.”
ANTICOV is an adaptive platform trial, an innovative type of clinical trial pioneered for cancer drugs that allow 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.