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The ANTICOV clinical trial responds 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 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 currently includes 26 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 helps 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 will test the safety and efficacy of treatments in up to 3,000 mild-to-moderate COVID-19 patients. ANTICOV aims to identify early treatments that can prevent progression of COVID-19 to severe disease and potentially limit transmission.

 

The initial focus of the ANTICOV trial are repurposed drugs where large-scale randomized clinical trials can 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 are currently under review.

 

ANTICOV is an adaptive platform trial, a flexible and innovative trial design that allows for treatments to be added or removed as evidence emerges.

Study drugs currently in ANTICOV

Fluoxetine / budesonide - now enrolling
Future arms are under preparation
INVESTIGATOR RESOURCES

New treatments will be added 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 (ACT-A) Therapeutics Partnership, co-convened by Unitaid and Wellcome on behalf of the COVID-19 Therapeutics Accelerator.

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 is conducting two ancillary studies.

Immunological study

An immunology study is being 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 will study antibodies and T-lymphocytes and compare the immune responses of symptomatic and asymptomatic patients. The study is co-led by ISGlobal and the Institute of Tropical Medicine (ITM) in Antwerp (Belgium).

 

Epidemiological study

An epidemiological study will also be carried out within the framework of the project to understand the factors affecting transmission of SARS-CoV-2 in households of SARS-CoV-2 patients in Sub-Saharan Africa. The study is led by ITM and is being conducted in Ghana, Kenya, Mozambique, and Ethiopia.

In collaboration with FIND, these countries will also evaluate 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