Last updated: January 30, 2023
Sponsor: ANRS, Emerging Infectious Diseases
Overall Status: Active - Recruiting
Phase
2/3
Condition
Sars-cov-2
Corona Virus
Covid-19
Treatment
N/AClinical Study ID
NCT04920838
ANRS COV33 COVERAGE-Africa
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adults 18 years of age at the time of screening or >= 40 years and presenting at leastone comorbidity : high blood pressure; a known obesity and/ or a known and treateddiabete.
- SARS-CoV-2 infection confirmed by molecular biology (RT-PCR on a nasopharyngeal ororopharyngeal swab) or by antigen test validated in the country according to nationalguidelines
- A viral syndrome with or without uncomplicated pneumonia, defined as blood oxygensaturation 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 ProgressionScale, 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
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 orshort-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 proscribedwith its use.
- Patients with known suicidal thoughts, severe psychiatric disorders or majordepression 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 timeduring the study, e.g. no access to or not comfortable with use of a smartphone orwith answering questions using a telephone, in the opinion of the Investigator orcannot 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 drugsthat may interact with any of the study IPs or are contraindicated as concomitanttherapy within the last 3 months prior to screening
Study Design
Total Participants: 600
Study Start date:
April 12, 2021
Estimated Completion Date:
August 31, 2023
Connect with a study center
Centre Muraz/INSP
Bobo-Dioulasso,
Burkina FasoActive - Recruiting
Centre de traitement des maladies à tendance épidémique de Gbessia
Conakry,
GuineaSuspended
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