Coverage Africa is a nested study in the large Anticov platform trial that aims togenerate data on new early treatment strategies for mild/moderate COVID-19 patients inresource-limited-settings to reduce the number progressing to severe forms requiringhospitalization, thereby relieving the burden on health care systems and contributing to"flattening the curve" in contexts where none pharmaceutical intervention such asquarantine are difficult to implement in large urban settings. Treating early when thevirus is still present might also limit transmission. Coverage Africa will be conductedin Guinea and Burkina Faso.The main objective is to conduct an open-label, multicenter, randomized, adaptiveplatform trial to test the safety and efficacy of several marketed products, includingantiviral 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 twosites in Burkina Faso.The current assessed treatments are now the association of Fluoxétine/Budésonide comparedwith a control arm: paracetamol.The adaptive design trial will allow for the removal of drugs, or the addition of newstudy arms when new data becomes available. Data on the primary efficacy parameters andsafety will be integrated with the primary endpoint based on an oxygen saturationpercentage (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 studycould also be interrupted for success earlier than planned with the identification of atreatment that significantly reduces hospitalization rate as evidence by results from theprimary endpoint.
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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.
Inclusion Criteria:
- Adults 18 years of age at the time of screening or >= 40 years and presenting at
least one comorbidity : high blood pressure; a known obesity and/ or a known and
treated diabete.
- SARS-CoV-2 infection confirmed by molecular biology (RT-PCR on a nasopharyngeal or
oropharyngeal swab) or by antigen test validated in the country according to
national guidelines
- A viral syndrome with or without uncomplicated pneumonia, defined as blood oxygen
saturation level (SpO2) >=94%.
- Mild Covid-19 symptoms with an onset < 7 days before inclusion.
- Signed written consent from the patient or his/her representative.
- No need an oxygen therapy according to international guidelines (WHO Progression
Scale, grade 2 to 4)
- Accepting and having the ability to be reached by telephone throughout the study.
- Having designated a contact person who can be contacted in case of emergency.
- Accepted to be reached by phone along throughout the study
Exclusion Criteria:
- Blood oxygen saturation level (SpO2) < 94%.
- Known hypersensitivity to investigational products
- Chronic treatment with inhaled corticosteroids (up to 30 days)
- Known history of renal or hepatic failure
- Abnormal physical examination findings:
- respiratory rate < 25 per minute;
- Clinical hypotension with associated signs justifying hospital care
- Feeling unwell for more than 7 days prior to screening.
- End-organ compromise requiring admission to a resuscitation or continuous care unit
or short-term life-threatening comorbidity with life expectancy < 3 months.
- For any new antiviral included in the study, prior treatment with the antiviral,
presence of contraindication to its use or intake of concomitant medication
proscribed with its use.
- Patients with known suicidal thoughts, severe psychiatric disorders or major
depression that is uncontrolled or controlled by one of the prohibited drugs
- Known history of long QT syndrome or severe ventricular cardiac arrhythmia
(ventricular tachycardia, patients with recovered ventricular fibrillation)
- Unwilling or unable to comply with the requirements of the study protocol at any
time during the study, e.g. no access to or not comfortable with use of a smartphone
or with answering questions using a telephone, in the opinion of the Investigator or
cannot use an inhalation chamber.
- Any other reason that makes it impossible to monitor the patient during the study.
- Enrolled in other clinical trials with unregistered drugs or with registered drugs
that may interact with any of the study IPs or are contraindicated as concomitant
therapy within the last 3 months prior to screening
Centre Muraz/INSP
Bobo-Dioulasso, Burkina Faso
Centre de traitement des maladies à tendance épidémique de Gbessia
Conakry, Guinea
Olivier Marcy, Dr
+33 557 57 47 23
olivier.marcy@u-bordeaux.fr
Anthony L'Hostellier
+33 557 57 47 23
anthony.lhostellier@u-bordeaux.fr
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