Clinical trial NCT04920838: Early Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection
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)
Conditions: Covid19
Covid19 Drug Treatment
Severe Acute Respiratory Syndrome Coronavirus 2
SARS-CoV2 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.
Interventions:
description: 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.
name: Nitazoxanide and Ciclésonide
type: Drug
description: 20 mg tablet daily
name: Telmisartan 20Mg Oral Tablet
type: Drug
description: 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.<br/>Duration of treatment: up to 14 days
name: Paracetamol
type: Drug
description: 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.
name: Fluoxétine and Budésonide
type: Drug
Study arms:
design_group_description: Patients in this arm will receive paracetamol during 14 days
design_group_title: Paracetamol
design_group_type: Active Comparator
design_group_description: Patients in this arm will receive the combination of ciclezonide (Alvesco® 160 µg ) / nitazoxanide (Netazox® 500 mg) during 14 days
design_group_title: Nitazoxanide and Ciclésonide
design_group_type: Experimental
design_group_description: Patients in this arm will receive telmisartan (Micardis® 20 mg) during 10 days
design_group_title: Telmisartan
design_group_type: Experimental
design_group_description: Patients in this arm will receive the combination of Fluoxétine (Fluoxétine Arrow® 40 mg ) / Budésonide (Budecort® 2*400 mcg) during 7 days
design_group_title: Fluoxétine and Budésonide
design_group_type: Experimental
Sponsor: France Recherche Nord & Sud SIDA HIV-Hepatites
Collaborators: Barcelona Institute for Global Health
Institut National de la Santé et de la Recherche Médicale
The Alliance for International Medical Action Asso
Université de Bordeaux
Drug name mappings:
name: 硝唑尼特
lang: CN
name: Nitazoxanide
lang: EN
name: 布地奈德
lang: CN
name: Budesonide
lang: EN
name: ブデソニド
lang: JP
name: 盐酸氟西汀
lang: CN
name: Fluoxetine Hydrochloride
lang: EN
name: 环索奈德
lang: CN
name: Ciclesonide
lang: EN
name: シクレソニド
lang: JP
name: 替米沙坦
lang: CN
name: Telmisartan
lang: EN
name: テルミサルタン
lang: JP