ANTICOV logo The ANTICOV clinical trial aimed 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- and middle-income countries.

Launched in November 2020 by the ANTICOV consortium, the study was 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 can prevent progression of COVID-19 to severe disease and potentially limit transmission.

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

ANTICOV researchers looked 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.

Major funding for the ANTICOV consortium was 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.

Project updates

2023

Following a decision to place recruitment on hold in 2022, the study was formally stopped and coordination of future consortium activities was transitioned to the Pandemic Preparedness Platform for Health and Emerging Infections Response (PANTHER).

A total of 1,941 patients were randomized in 12 countries prior to the study’s conclusion. Data cleaning and database lock were completed, and data will be transferred to the Infectious Diseases Data Observatory (IDDO) platform to ensure worldwide accessibility to other researchers.

Recruitment for ANTICOV’s ancillary studies concluded in the fourth quarter of 2022, with 512 and 434 patients recruited in the immunological and epidemiological studies, respectively. The database for the immunological study was locked on 23 December 2022. The database for the epidemiological study database was locked on 25 May 2023. Results for both studies are expected to be published in the last quarter of 2024.

December 2022

ANTICOV recruitment was placed on hold pending the revision of the primary endpoint and the decision to test a new treatment arm. By the end of 2022, 1,753 patients across 12 countries had been recruited into the master study. The immunological and epidemiological ancillary studies were stopped, with results expected in 2023. The ivermectin/ASAQ arm of the study was stopped based on a review of the scientific data and to prioritize the most promising treatment option.

July 2022

ANTICOV 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. Read the press release

February 2022

ANTICOV has started the recruitment of participants to test a new promising drug combination, fluoxetine and budesonide. Read the press release

Data Safety Monitoring Board decision to stop testing the drug combination nitazoxanide and inhaled ciclesonide. Read the press release

January 2022

Patient recruitment is ongoing at 15 sites in 10 countries to test three treatment combinations: nitazoxanide with the inhaled glucocorticoid ciclesonide; ivermectin with artesunate and amodiaquine (ASAQ); and fluoxetine with the inhaled corticosteroid budesonide. More than 1200 patients have been recruited to date. Two interim analyses have been conducted, and no change to the study design was recommended. 

ANTICOV India, a study similar to ANTICOV, will be conducted at 15 sites in India, with the first patient recruited expected in early 2022. 

April 2021

ANTICOV has started the recruitment of participants to test a new potential treatment that combines the well-known antiparasitic nitazoxanide and the inhaled corticosteroid ciclesonide. The first participants in the new study arm have been recruited in the Democratic Republic of Congo (DRC) and the Republic of Guinea. In the coming weeks, additional trial sites will enrol participants in Burkina Faso, Cameroon, Côte d’Ivoire, Equatorial Guinea, Ethiopia, Ghana, Kenya, Mali, Mozambique, Sudan, and Uganda. Read the press release

November 2020

Thirteen African countries and an international network of research institutions have joined forces to launch ANTICOV, the largest COVID-19 clinical trial in mild-to-moderate outpatients in Africa. Read the press release