Early Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
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 two assessed treatments are now the association of Ciclésonide / Nitazoxanide and the
Telmisartan, 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 December 2021. 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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborators:
Alliance for International Medical Action Barcelona Institute for Global Health Centre Muraz Institut National de la Santé Et de la Recherche Médicale, France PACCI Program University of Bordeaux