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

Rachel M. Cohen rachel.cohen72 at gmail.com
Tue Nov 24 04:33:08 PST 2020


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
<https://dndi.org/research-development/portfolio/anticov/> 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, 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
<https://www.who.int/initiatives/act-accelerator/faq> 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.

 

‘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
<https://www.who.int/teams/blueprint/covid-19> 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.

 

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


 
<https://dndi.org/wp-content/uploads/2020/11/DNDi-ANTICOV-Backgrounder-Nov20
20-EN.pdf> Background document


 


Media contacts


DNDi
Frédéric Ojardias (Geneva)
 <mailto:fojardias at dndi.org> fojardias at dndi.org 
+41 79 431 62 16 

 

Linet Otieno (Nairobi)
 <mailto:latieno at dndi.org> latieno at dndi.org
+254 733 624 206

 

Ilan Moss (New York)
 <mailto:imoss at dndi.org> imoss at dndi.org
+1 646 266 5216

 

Francine Ngalula (Kinshasa)
 <mailto:francinengal at gmail.com> 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 |  <mailto:rcohen at dndi.org>
rcohen at dndi.org | skype: rachelmcohen

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

 

 



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