Test the efficacy and safety of treatments in mild to moderate COVID-19 patients in low-resource settings
last phase of drug development
updated 21 Feb 2025
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.
Target product profile for mild/moderate outpatient COVID-19
| Ideal | Acceptable | |
|---|---|---|
| Indication | For treatment of non-severe and uncomplicated, symptomatic COVID-19 disease and clear the virus This will not address potential other use for asymptomatic or contacts (this would require another TPP) |
For treatment of non-severe and uncomplicated, symptomatic COVID-19 disease (with the intent to prevent progression to severe disease) Complicated cases to be defined in an Appendix based on agreed criteria (WHO/ACT-A, ANTICOV Consortium) |
| Target population(s) | Adults, pregnant and breastfeeding women, and children who are > 6 years Can be treated as outpatients Can be used in HIV+ patients (provided no DDI) |
Adults Can be treated as outpatients |
| Target countries | Global | Global |
| Expected efficacy/ endpoints | Primary: decrease progression of disease vs SoC by 50% measured as SpO2 ≤ 93% at end of treatment Secondary: improvement of pre-existing symptoms Direct antiviral efficacy measured as a proportion of patients with negative respiratory swab on Day 7 after treatment initiation measured by RT-PCR |
Primary: decrease progression of disease vs SoC by 50% measured as SpO2 ≤ 93% at end of treatment Secondary: improvement of pre-existing symptoms |
| Safety | No need for laboratory or ECG monitoring (including for treatment initiation) | No need for systematic follow-up laboratory or ECG monitoring Clinical benefit outweighs risks during active infection and transmission – SAEs are no higher than for SoC |
| Coadministration | Combination with other COVID-19 interventional agents not contraindicated (antibiotics, immunomodulators). | Combination with other COVID-19 interventional agents not contraindicated (antibiotics, immunomodulators) |
| Contraindications, warnings, precautions, interactions, and use during pregnancy and lactation | Could be co-administered in TB, HIV and malaria co-infected patients (no DDI with rifampicin) Efficacy and safety in malnourished patients Could be administered with antidiabetics, anti-hypertensive treatments |
Cannot be administered in loa-loa patients (specific to ivermectin) |
| Route of administration | Multiple formulations – oral and pediatric formulations | Oral tablet or capsule preferred Sub-cutaneous or depot IM only if single dose treatment |
| Dosage form and schedule | Once a day ≤ one week (including for children, adolescents) | Up to 3x per day (oral) if limited to 3 days max 2x per day – up to 2 weeks max |
| Shelf-life | Finished product stable for 5 years | Finished product stable for 2 years |
| Cost | Under 5 USD/regimen | Under 10 USD/regimen |
| Storage | Store at room temperature (defined as 30 °C/75 % RH (zone IV B conditions) | Store at room temperature (defined as 30 °C/75 % RH (zone IV B conditions) |
| Product registration path | Label extension via AMA – WHO-PQ | Label extension via AMA – WHO-PQ |
Project updates
2024
A total of 1,942 patients were randomized in 12 countries prior to the study’s conclusion. Database lock was completed in November 2023, and data were transferred to the Infectious Diseases Data Observatory (IDDO) platform to ensure worldwide accessibility to other researchers. Final results were available in December 2023. The clinical study report was completed in March 2024.
ANTICOV was completed in 2024, with five treatments tested. Early futility was demonstrated for one arm, but due to the low probability of reaching any statistical significance after the Omicron wave, it was decided to stop the study.
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
News & resources
- 5 July 2022 – Brazil joins ANTICOV trial to find early treatments for people with mild-to-moderate COVID-19
- 5 July 2022 – Brasil participa de estudo global que busca tratamento barato para covid em países pobres, BBC News Brasil
- 17 March 2022 – Covid-19 en Afrique : pour l’étude Anticov, la nouvelle association thérapeutique ne réduit pas le risque d’hospitalisation chez les patients atteints d’une forme légère à modérée, Actualité CD
- 28 February 2022 – ANTICOV trial finds drug combination nitazoxanide + ciclesonide does not reduce risk of hospitalization in COVID-19 outpatients
- 10 February 2022 – ANTICOV: clinical trial for COVID-19 in low-resource settings to test a new combination treatment
- 21 October 2021 – The ANTICOV clinical trial in Guinea
- 13 September 2021 – Interview de Nathalie Strub-Wourgaft sur la recherche de médicaments contre le COVID-19, France Culture
- 30 July 2021 – ‘A clear demonstration of the capacity in Africa to conduct extremely complex studies’ – Dr John Amuasi on the ANTICOV trial in Ghana
- 29 July 2021 – Recruitment begins in Mozambique for ANTICOV clinical trial of early treatments for COVID-19
- 28 June 2021 – Why Mali joined the ANTICOV clinical trial: A conversation with Dr Samba Sow
- 24 June 2021 – La plus vaste étude clinique sur les cas légers de COVID-19 a été lancée sur le continent, France 24
- 18 June 2021 – A few moments with an ANTICOV investigator: Dr Bernhards Ogutu in Kenya
- 19 May 2021 – AVAREF and ANTICOV: Accelerating regulatory approval for COVID-19 treatments in Africa
- 11 May 2021 – L’essai clinique ANTICOV, RFI Priorité Santé
- 5 May 2021 – La plus vaste étude en Afrique sur les cas légers de Covid, RTS
- 3 May 2021 – DR Congo and Guinea to test early-stage Covid drug, BBC
- 30 April 2021 – L’Afrique face au Covid-19 : la peur du scénario indien, Le Monde
- 27 April 2021 – Preparan el mayor ensayo clínico para tratar casos leves de COVID-19 y limitar contagios, El País
- 27 April 2021 – Ensaio vai testar medicamentos para tratamento precoce em África, Notícias ao Minuto
- 27 April 2021 – Prueban una combinación de fármacos para casos leves de covid, El Correo
- 27 April 2021 – En África probarán una nueva combinación de fármacos contra el Covid-19, El Diario
- 27 April 2021 – El mayor ensayo clínico contra la covid en África probará una nueva combinación de fármacos, La Vanguardia
- 27 April 2021 – Covid-19 : les participants à l’évaluation d’une association thérapeutique contre les cas légers en Afrique sont recrutés notamment en RDC, Actualité CD
- 27 April 2021 – Une grande étude pour traiter la Covid-19 en Afrique, Deutsche Welle
- 27 April 2021 – Could a new COVID-19 treatment be the answer to combating the pandemic in Africa?, Health Policy Watch
- 27 April 2021 – El mayor ensayo clínico en África contra el COVID-19 probará una nueva combinación de fármacos que incluye nitazoxanida, Infobae
- 27 April 2021 – A la recherche d’un traitement anti-covid pour l’Afrique, Le Temps
- 27 April 2021 – ANTICOV: largest clinical trial in Africa for people with mild COVID-19 to test new drug combination
- 8 March 2021 – System failure, Foreign Affairs
- 29 January 2021 – Afrikas Kampf gegen Corona: Wie die Erfolgsgeschichte zur moralischen Tragödie verkam, NZZ
- 24 November 2020 – Adaptive platform trials for COVID-19 with Dr Roger Lewis
- 24 November 2020 – Lancement du project ANTICOV dans 13 pays africains, Journal Télévisé en Lingala Facile
- 24 November 2020 – Largest clinical trial in Africa to treat COVID-19 cases before they become severe is launched in 13 countries
Clinical trials documents
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