Status:
UNKNOWN
Early Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
University of Bordeaux
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Covid19
Covid19 Drug Treatment
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04920838
Start Date
April 12 2021
End Date
August 1 2023
Last Update
January 31 2023
Active Locations (2)
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1
Centre Muraz/INSP
Bobo-Dioulasso, Burkina Faso
2
Centre de traitement des maladies à tendance épidémique de Gbessia
Conakry, Guinea