Early Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection — COVERAGE-A  

Covid19 Clinical Trial

Official title: Early Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection: A Multi-Arm Multi-Stage Randomized Trial (MAMS) to Evaluate the Effectiveness of Several Specific Treatments in Reducing the Risk of Clinical Worsening or Death in Sub-Saharan Africa (COVERAGE-Africa)

Status Recruiting

Clinical Trial Summary

Coverage Africa is a nested study in the large Anticov platform trial that aims to generate data on new early treatment strategies for mild/moderate COVID-19 patients in resource-limited-settings to reduce the number progressing to severe forms requiring hospitalization, thereby relieving the burden on health care systems and contributing to "flattening the curve" in contexts where none pharmaceutical intervention such as quarantine are difficult to implement in large urban settings. Treating early when the virus is still present might also limit transmission. Coverage Africa will be conducted in Guinea and Burkina Faso.

The main objective is to conduct an open-label, multicenter, randomized, adaptive platform trial to test the safety and efficacy of several marketed products, including antiviral therapies versus control in mild/moderate of coronavirus disease 2019 (Covid-19) in resource-limited-settings.

The study aims to recruit 600 patients in both countries, one site in Guinea and two sites in Burkina Faso.

The current assessed treatments are now the association of Fluoxétine/Budésonide compared with a control arm: paracetamol.

The adaptive design trial will allow for the removal of drugs, or the addition of new study arms when new data becomes available. Data on the primary efficacy parameters and safety will be integrated with the primary endpoint based on an oxygen saturation percentage (SpO2) ≤ 93% or death within 14 days after randomization to treatment, including death for any reason.

Study will run until August 2022. However, with the proposed adaptive design, the study could also be interrupted for success earlier than planned with the identification of a treatment that significantly reduces hospitalization rate as evidence by results from the primary endpoint.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Covid19
• Infections
• SARS-CoV2 Infection
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2

• NCT number: NCT04920838
• Study type: Interventional
• Source: ANRS, Emerging Infectious Diseases
• Contact: Olivier Marcy, Dr
• Phone: +33 557 57 47 23
• Email: olivier.marcy@u-bordeaux.fr
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 12, 2021
• Completion date: August 2023