Largest clinical trial in Africa to treat mild to moderate COVID-19 patients launched in 13 countries
Thirteen African countries and an international network of research institutions have joined forces to launch the largest clinical trial in mild-to-moderate COVID-19 outpatients in Africa. The ANTICOV clinical trial aims to identify treatments for these cases and thus to contribute to the prevention of spikes in hospitalisation that could overwhelm health systems in Africa.*
The trial will be conducted by the ANTICOV consortium. It includes 26 prominent African and global R&D organisations. It is coordinated by the Drugs for Neglected Diseases initiative (DNDi).
“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?”
Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention
Go to the ANTICOV press release
Funding
Major funding for the ANTICOV consortium is provided by the German Federal Ministry of Education and Research (BMBF) and by the global health agency Unitaid. Early support to launch the initiative was provided by EDCTP under its Covid-19 Emergency call with additional funding from the Swedish government, and the Starr International Foundation, Switzerland. This funding contributed to finalising the study protocol and facilitating expedited reviews by in-country regulatory and ethics authorities. It also supported the timely preparation of trial sites in selected African countries and a robust, standardised data management system.
“EDCTP is proud to be a member of the COVID-19 Clinical Research Coalition and a funder of the ANTICOV trial in Africa. By treating COVID patients at an early stage, this trial will identify promising drugs to stop the development of severe illness, reduce transmission of the infection, and safeguard hospital resources for those who need them most.”
Dr Pauline Beattie, EDCTP Operations Manager
Study approach
ANTICOV clinical trials will be carried out at 19 sites in Burkina Faso, Cameroon, Côte d’Ivoire, the Democratic Republic of Congo (DRC), Equatorial Guinea, Ethiopia, Ghana, Guinea, Kenya, Mali, Mozambique, Sudan, and Uganda. The study is an open-label, randomised, 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. The adaptive platform trial is an innovative type of clinical trial pioneered for cancer drugs. It allows for several treatments to be tested simultaneously. Adaptive platform trials enable rapid decisions based on the ongoing analysis of results.
The study 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.
All clinical trial data generated by ANTICOV will be integrated and shared openly and transparently to inform public health policy. Every effort will be made to work with all relevant partners to ensure that treatments that prove safe and effective will be affordable, available, and accessible for all.
International collaboration
ANTICOV researchers are actively looking to select the most promising treatments from ongoing global scientific efforts with proof of efficacy, in collaboration with the ACT-A Therapeutics Partnership, co-convened by Unitaid and Wellcome on behalf of the COVID-19 Therapeutics Accelerator.
ANTICOV is aligned with the WHO R&D Blueprint, which aims to improve coordination between scientists and global health professionals, accelerate the research and development process, and develop new norms and standards to learn from and improve upon the global COVID-19 response.
EDCTP’s contribution to the COVID-19 response
Since the announcement made in June 2020 of EDCTP’s COVID-19 emergency funding for twenty research projects under the COVID-19 Emergency response call, EDCTP has continued to work closely with its member countries and other public and private partners to avoid duplication, enhance synergy, and advocate for more funding, in order to ultimately maximise the impact of its COVID-19 funding.
Consequently, with funds from the European Union and the UK Department for Health and Social Care (DHSC), a further three reserve projects have been awarded by EDCTP and one additional reserve project is expected to be supported through an EDCTP PSIA (a Participating States’ Initiated Activity) funded by Austria, Norway, and South Africa. This brings the combined total budget for these 24 projects to approximately €11.75 million in support of research activities in sub-Saharan Africa to manage and/or prevent the spread of the current COVID-19 outbreak.
At the project level, EDCTP-funded COVID-19 projects are collectively expected to leverage €4.46 million indicative cash and in-kind co-funding, which is equivalent to 37% of the funder contributions at the call level. The highest cash contributors include Unitaid, the German Federal Ministry of Education and Research/KfW, and Wellcome Trust, while the Zambian Ministry of Health and the TASK Foundation provide the highest in-kind contributions.
EDCTP is also sustaining its support for COVID-19 through the remaining calls for proposals that have been launched during the course of 2020, for which the disease remit has been expanded to include COVID-19. Moreover, EDCTP is a member of the COVID-19 Clinical Research Coalition.
*This news item is based on the ANTICOV press release, which is available on the DNDi website.