[Ip-health] DNDi: Largest clinical trial in Africa to treat COVID-19 cases before they become severe is launched in 13 countries

Simon Collins simon.collins at i-base.org.uk
Mon Nov 30 10:30:21 PST 2020

Hi Rachel

Although the idea of running this large study has ;ots of good points, I wish more time was spent to find more promising treatments.

Both hydroxychloroquine and lopinaivr/r have far more evidence showing that they are unlikely to work than any chance of being effective. As such, this is a difficult study to support until better drugs are included - detailed in i-Base article below.

International COVID-19 study launches in Africa but with drugs that have little chance of working (ANTICOV)

We have already spoken, but is there general community support for these options from activists in these countries?

The study has been ready since July so there has been plenty of time for engagement.



On 24 Nov 2020, at 12:33, 'Rachel M. Cohen' rachel.cohen72 at gmail.com [internationaltreatmentpreparedness] <internationaltreatmentpreparedness-noreply at yahoogroups.com> wrote:

Largest clinical trial in Africa to treat COVID-19 cases before they become severe is launched in 13 countries
Will test a number of promising treatments in urgently needed focus on mild and moderate cases
Nairobi/Kinshasa/Geneva – 24 November 2020
Thirteen 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 ANTICOV clinical trial aims to respond to the urgent need to identify treatments that can be used to treat mild and moderate cases of COVID-19 early and prevent spikes in hospitalization that could overwhelm fragile and already overburdened health systems in Africa.
The clinical trial will be carried out at 19 sites in 13 countries by the ANTICOV consortium <https://dndi.org/research-development/portfolio/anticov/>, 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, 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 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 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 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 <https://www.who.int/initiatives/act-accelerator/faq> (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.
‘The ANTICOV consortium is a broad partnership bringing African scientific leaders and global R&D organizations together to respond to an urgent unmet medical need. Collaboration is the only way to provide robust scientific responses to these research questions,’ said Dr Nathalie Strub-Wourgaft, Director of COVID-19 Response for DNDi. ‘The trial was designed in a way that enables rapid and flexible decisions as we gather knowledge.’
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.   
The trial was reviewed with support from the African Vaccine Regulatory Forum (AVAREF), a platform established by the World Health Organization (WHO) in 2006, which was recently mandated to expedite clinical trial reviews for COVID-19. Made up of representatives from countries’ ethical and regulatory review bodies, AVAREF simplifies and helps accelerate country-level approvals.
ANTICOV is aligned with the WHO R&D Blueprint <https://www.who.int/teams/blueprint/covid-19>, 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.
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.
The ANTICOV consortium is mobilizing a wide network of diverse partners with recognised experience in clinical research. The 26 members of the ANTICOV consortium are:
Alliance for International Medical Action (ALIMA), France / Senegal
Agence Nationale de Recherche sur le Sida et les Hépatites Virales (ANRS), France
Bahir Dar University, Ethiopia
Barcelona Institute for Global Health (ISGlobal), Spain
Bernhard-Nocht-Institut für Tropenmedizin (BNITM), Germany
Centre Muraz, Institut National de Santé Publique, Burkina Faso
Centre for Research in Therapeutic Sciences, Kenya
Centro de Investigação em Saúde de Manhiça, Mozambique
Centro de Investigação e Treino em Saúde da Polana Caniço (CISPOC), Instituto Nacional de Saúde, Mozambique
Centre Pasteur du Cameroun (CPC), Cameroon
Centre Pour Le Développement Des Vaccins, Ministry of Health, Mali
Centre Suisse de Recherches Scientifiques (CSRS), Côte d’Ivoire
Drugs for Neglected Diseases initiative (DNDi), Switzerland – (coordinating partner)
Epicentre, France
Foundation for Innovative New Diagnostics (FIND), Switzerland
Ifakara Health Institute, Tanzania
Infectious Diseases Data Observatory (IDDO), United Kingdom
Institute of Endemic Diseases, University of Khartoum, Sudan
Institute of Tropical Medicine, Antwerp (ITM), Belgium
Institut National de Recherche Biomédicale (INRB), Democratic Republic of Congo
The Kenya Medical Research Institute (KEMRI), Kenya
Kumasi Centre for Collaborative Research in Tropical Medicine (KCCR), Ghana
Medicines for Malaria Venture (MMV), Switzerland
Swiss Tropical and Public Health Institute (Swiss TPH), Switzerland
Université de Bordeaux – Institut National de la Santé et de la Recherche Médicale (INSERM), France
University of Gondar, Ethiopia
More information
Background document <https://dndi.org/wp-content/uploads/2020/11/DNDi-ANTICOV-Backgrounder-Nov2020-EN.pdf>
Media contacts
Frédéric Ojardias (Geneva)
fojardias at dndi.org <mailto:fojardias at dndi.org> 
+41 79 431 62 16 
Linet Otieno (Nairobi)
latieno at dndi.org
 <mailto:latieno at dndi.org>+254 733 624 206
Ilan Moss (New York)
imoss at dndi.org <mailto:imoss at dndi.org>
+1 646 266 5216
Francine Ngalula (Kinshasa)
francinengal at gmail.com <mailto:francinengal at gmail.com>
+243 816 402 389



Rachel M. Cohen | Regional Executive Director

Drugs for Neglected Diseases initiative – North America

40 Rector Street, 16th Floor | New York, NY 10006 | USA 

T: +1 646 215 7083 | M: +1 646 824 3064 | rcohen at dndi.org <mailto:rcohen at dndi.org> | skype: rachelmcohen

Best Science for the Most Neglected | www.dndi.org <http://www.dndi.org/>


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Simon Collins
HIV i-Base
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