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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
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.
20 mg tablet daily
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
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.
Centre Muraz/INSP
Bobo-Dioulasso, Burkina Faso
RECRUITINGCentre de traitement des maladies à tendance épidémique de Gbessia
Conakry, Guinea
SUSPENDEDSpO2 ≤ 93% within 14 days
Percentage of participant presenting an oxygen saturation percentage (SpO2) ≤ 93% or death within 14 days after randomization to treatment.
Time frame: From inclusion (day 0) to day 14.
Death within 14 days
Percentage of participant dead within 14 days after randomization to treatment, including death for any reason.
Time frame: From inclusion (day 0) to day 14.
Death within 28 days
Percentage of participant dead within 28 days after randomization to treatment, including death for any reason.
Time frame: From inclusion (day 0) to day 28.
Occurence of at least one grade 3 or 4 clinical or biological adverse event within 14 days
Occurence of at least one grade 3 or 4 clinical or biological adverse event within 14 days
Time frame: From inclusion (day 0) to day 14.
Number of hospitalizations due to severe progression
Hospitalisation due to aggravation of COVID-19, including hospitalisation's reason as described below * Request of mechanical ventilation and/or Intensive Care Unit (ICU) * Non-ICU hospitalisation, requiring supplemental oxygen * Non-ICU hospitalisation, not requiring supplemental oxygen
Time frame: From inclusion (day 0) to day 28.
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