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

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

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.

Sponsors & Collaborators

• University of Bordeaux

  collaborator OTHER

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• PACCI Program

  collaborator OTHER

• Alliance for International Medical Action

  collaborator OTHER

• Centre Muraz

  collaborator OTHER

• Barcelona Institute for Global Health

  collaborator OTHER

• ANRS, Emerging Infectious Diseases

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-12

Primary Completion

2023-08-31

Completion

2023-08-31

Countries

• Burkina Faso
• Guinea

Study Locations