The ANTICOV study, a platform clinical trial which aims to find early treatments for mild-to-moderate cases of COVID-19 and is currently conducted in 13 African countries, is expanding to Brazil through a collaboration with the TOGETHER study team, a Brazilian-Canadian partnership that is running another large platform trial in the country.
‘The COVID-19 pandemic is far from over. New waves fuelled by new variants are still putting public health systems around the world under heavy strain,’ said Dr Nathalie Strub-Wourgaft, Director of the COVID-19 Response for the non-profit research and development organization Drugs for Neglected Diseases initiative (DNDi), which is coordinating the ANTICOV consortium.
‘We still need oral COVID-19 treatments that are safe, affordable, and globally accessible. We need easy-to-administer drugs for outpatients diagnosed within seven days after the first appearance of symptoms. The TOGETHER study has already identified two effective treatments for patients with mild-to-moderate symptoms, and we welcome this partnership with its researchers in Brazil.’
Launched in September 2020, ANTICOV is a collaboration of now 27 partners from leading research institutions and international health organizations aiming to identify COVID-19 treatments that are optimized for use in low- and middle-income countries (LMICs) and that can prevent progression to severe disease.
The ANTICOV trial in Brazil will include up to 600 patients in up to 21 sites. The data gathered will be pooled with the existing ANTICOV study carried out in 13 African countries.
‘The goal of ANTICOV is to identify the best treatment regimen that could be used for test-and-treat strategies in LMICs – and could therefore prevent the evolution to a severe form, potentially limit transmission, reduce the risk of developing a long-COVID, and prevent hospitalization and death that periodically threaten to overwhelm hospitals,’ said Dr Gilmar Reis, Associate Professor at the Universidade Catolica de Minais Gerais and Co-Principal Investigator of the TOGETHER trial. ‘This is a research priority and the expansion of the ANTICOV trial to Brazil is bringing us closer to that goal.’
More than 6,000 patients have enrolled to date in the TOGETHER trial, which has evaluated 11 treatments for patients with mild-to-moderate COVID-19 cases. The TOGETHER trial has already shown in August 2021 that a compound named fluvoxamine is effective against COVID-19 and can reduce deaths and hospitalizations by up to 30%. More recently in March 2022, the trial has also found that peginterferon lambda reduced hospitalizations or death by 60% with early treatment.
The ANTICOV trial in Brazil will start by testing a new drug combination, fluoxetine and inhaled budesonide. Fluoxetine is a safe and widely available anti-depressant that belongs to the same class of compounds as fluvoxamine. Budesonide is a safe and affordable inhaled corticosteroid thought to have anti-inflammatory efficacy against COVID-19. Studies have shown that budesonide, if taken early enough, improves recovery time in outpatients with COVID-19 and may reduce hospitalizations and deaths. The combination could be effective for the first, viral replication stage of the infection and could also decrease the impact of the later, inflammatory stage that can start a few days later.
This is the fifth arm tested by ANTICOV. ANTICOV is an ‘adaptive platform’ trial, a flexible and innovative trial design that allows for treatments to be added or removed as new evidence emerges. Data from the ANTICOV trial has already demonstrated that the drug combination nitazoxanide and ciclesonide has low probability of reducing the risk of hospitalization in COVID-19 outpatients in comparison with paracetamol.
The selection of drugs for ANTICOV is informed by reviews conducted by the expert working group of the Unitaid, Wellcome, and Global Fund-led Access to COVID-19 Tools Accelerator (ACT-A) Therapeutics Partnership. The study will soon expand to South Asia.
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. Additional support comes from the European & Developing Countries Clinical Trials Partnership (EDCTP) – under its second programme supported by the European Union with additional funding from the Swedish government – the Starr International Foundation and the Stavros Niarchos Foundation (SNF).
List of ANTICOV partners
The ANTICOV consortium is mobilizing a wide network of diverse partners with recognised experience in clinical research. The 27 members of the ANTICOV consortium are:
- ALIMA (The Alliance for International Medical Action), France / Senegal
- ANRS | Maladies infectieuses émergentes, 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
- FIND, the global alliance for diagnostics, 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
- TOGETHER trial, Brazil, Canada
- Université de Bordeaux – Institut National de la Santé et de la Recherche Médicale (INSERM), France
- University of Gondar, Ethiopia
ANTICOV’s innovative and flexible platform trial has been designed by Berry Consultants, LLC, a statistical consulting company specializing in the Bayesian approach to medical statistics.
A not-for-profit research and development organization, DNDi works to deliver new treatments for neglected patients, those living with Chagas disease, sleeping sickness (human African trypanosomiasis), leishmaniasis, filarial infections, mycetoma, paediatric HIV, and hepatitis C. DNDi is also coordinating the ANTICOV clinical trial to find treatments for mild-to-moderate COVID-19 cases in low-resource settings. Since its inception in 2003, DNDi has delivered twelve new treatments to date, including new drug combinations for kala-azar, two fixed-dose antimalarials, and DNDi’s first successfully developed new chemical entity, fexinidazole, approved in 2018 for the treatment of both stages of sleeping sickness. dndi.org
The TOGETHER Trial represents an international collaboration of diverse partners committed to preventing death and improving health outcomes for all people affected by COVID-19. Resources and expertise from all countries working in TOGETHER network are being brought to bear to identify new potential uses of new existing medications, which can be used to prevent COVID-19 related morbidity and mortality. This international trial is financially supported by a mix of biotechnology companies and private sector philanthropic agencies, which have dedicated financial resources to the fight against COVID-19 in low and middle-income countries. togethertrial.com
Frédéric Ojardias (Geneva)
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Marcela Dobarro (Rio)
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Ilan Moss (New York)
+1 646 266 5216
Dr Edward Mills (Vancouver)
Co-Principal Investigator, TOGETHER Trial
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Photo credit: CardResearch, Belo Horizonte, Minas Gerais, Brazil