NCT04920838

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

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: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19
• Covid19 Drug Treatment
• Severe Acute Respiratory Syndrome Coronavirus 2
• SARS-CoV2 Infection

Interventions

Type	Name	Description
DRUG	Nitazoxanide and Ciclésonide	Inhaled Ciclésonide: 320 mcg BID per day and Oral Nitazoxanide:2000 mg tablets daily (divided into two daily intakes of two tablets of nitazoxanide 500 mg) during 14 days.
DRUG	Telmisartan 20Mg Oral Tablet	20 mg tablet daily
DRUG	Paracetamol	Tablets containing 500 mg of paracetamol. One to two tablets every 4-6 hours as required, to a maximum of 6 tablets (3 grams) daily in divided doses. Duration of treatment: up to 14 days
DRUG	Fluoxétine and Budésonide	Inhaled Budésonide: 400mcg BID per day and oral Fluoxétine : 80mg tablets daily (divided into two daily intakes of two tablets of Fluoxétine 40 mg) during 7 days.

Timeline

• Start date: 2021-04-12
• Primary completion: 2023-08-01
• Completion: 2023-08-01
• First posted: 2021-06-10
• Last updated: 2023-01-31

Locations

2 sites across 2 countries: Burkina Faso, Guinea