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The ANTICOV clinical trial aimed to respond to the need to identify treatments that could be used to treat mild and moderate cases of COVID-19 early and prevent spikes in hospitalizations that could overwhelm fragile and already overburdened health systems in low-resource settings.

 

 

The trial was launched in September 2020  in 13 countries by the ANTICOV consortium. The consortium included 27 prominent global research and development (R&D) organizations, coordinated by DNDi.

 

 

One of the largest multi-country trials focusing exclusively on mild and moderate cases of COVID-19, ANTICOV helped address the relative neglect of clinical research for treatment in an outpatient setting during the COVID-19 pandemic in Africa, Asia, and Latin America.

Participating countries

Brazil

Burkina Faso

Cameroon

Côte d’Ivoire

Democratic Republic of Congo

Ethiopia

Ghana

Guinea

Kenya

Mali

Mozambique

Sudan

Tanzania

Uganda

STUDY SITES

ANTICOV is an open-label, randomised, comparative, ‘adaptive platform trial’ that tested the safety and efficacy of treatments in mild-to-moderate COVID-19 patients. ANTICOV aimed to identify early treatments that could prevent progression of COVID-19 to severe disease and potentially limit transmission.

 

 

The initial focus of the ANTICOV trial was repurposed drugs where large-scale randomized clinical trials could provide missing efficacy data in mild-to-moderate patients. Safe and affordable repurposed drugs such as artesunate/amodiaquine, ivermectin, nitazoxanide, ciclesonide along with other candidates were reviewed.

 

 

ANTICOV was designed as an adaptive platform trial, a flexible and innovative trial design that allowed for treatments to be added or removed as evidence emerged.

Timeline: ANTICOV Platform Trial

Launch of the ANTICOV trial testing lopinavir/ritonavir and hydroxychloroquine

December 2020

Data Safety Monitoring Board decision to stop testing lopinavir/ritonavir and hydroxychloroquine

Inclusion of the nitazoxanide / ciclesonide arm

July 2021

Inclusion of the artesunate amodiaquine / ivermectin arm

September 2021

Data Safety Monitoring Board interim analysis review meeting

February 2022

Inclusion of the fluoxetine / budesonide arm and Data Safety Monitoring Board decision to stop testing nitazoxanide/ciclesonide

September 2022

Decision by the Joint Steering Committee to stop the artesunate amodiaquine / ivermectin arm

About the Ancillary Studies

The project conducted two ancillary studies.


Immunological study

An immunology study carried out in 6 countries (DRC, Ethiopia, Ghana, Kenya, Mozambique, and Sudan) to analyse whether the treatments tested in the clinical trial in patients with mild to moderate COVID-19 alter the strength or duration of immune responses to SARS-CoV-2. The researchers studied antibodies and T-lymphocytes and compared the immune responses of symptomatic and asymptomatic patients. The study was co-led by ISGlobal and the Institute of Tropical Medicine (ITM) in Antwerp (Belgium).

 

Epidemiological study

An epidemiological study carried out to understand the factors affecting transmission of SARS-CoV-2 in households of SARS-CoV-2 patients in Sub-Saharan Africa. The study was led by ITM and conducted in Ghana, Kenya, Mozambique, and Ethiopia.

In collaboration with FIND, these countries also evaluated the sensitivity and specificity of an Ag-RDT compared to PCR in persons with symptomatic (mild/moderate) and asymptomatic COVID-19 illness.


ANTICOV is registered at the Pan African Clinical Trials Registry (PACTR) Study ID: PACTR202006537901307

Funders

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.

 

  • European and Developing Countries Clinical Trials Partnership (EDCTP2), Europe
  • Federal Ministry of Education and Research (BMBF) through KfW, Germany
  • Starr International Foundation, Switzerland
  • Stavros Niarchos Foundation (SNF)
  • UK aid, UK
  • Unitaid, Switzerland
  • Other private foundations and individuals

Partners

Community Advisory Group

The Community Advisory Group provide a vehicle for effective community input. Membership includes:

  • Jacqueline Wambui Mwangi (Chair), East Africa 
  • Mwifadhi Mrisho, East Africa 
  • Calice Talom Yomgne, Central Africa 
  • Maisa Mustafa Ahmed Elfadul, North Africa 
  • Gertrude N. Kiwanuka, East Africa  
  • Iriebi Gboh, West Africa  
  • Moro Amos Soh, West Africa