Early Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection
COVERAGE-A
1 other identifier
interventional
600
2 countries
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 covid19
Started Apr 2021
Longer than P75 for phase_2 covid19
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 12, 2021
CompletedFirst Submitted
Initial submission to the registry
May 4, 2021
CompletedFirst Posted
Study publicly available on registry
June 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedJanuary 31, 2023
July 1, 2022
2.3 years
May 4, 2021
January 30, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
SpO2 ≤ 93% within 14 days
Percentage of participant presenting an oxygen saturation percentage (SpO2) ≤ 93% or death within 14 days after randomization to treatment.
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.
From inclusion (day 0) to day 14.
Secondary Outcomes (3)
Death within 28 days
From inclusion (day 0) to day 28.
Occurence of at least one grade 3 or 4 clinical or biological adverse event within 14 days
From inclusion (day 0) to day 14.
Number of hospitalizations due to severe progression
From inclusion (day 0) to day 28.
Study Arms (4)
Paracetamol
ACTIVE COMPARATORPatients in this arm will receive paracetamol during 14 days
Nitazoxanide and Ciclésonide
EXPERIMENTALPatients in this arm will receive the combination of ciclezonide (Alvesco® 160 µg ) / nitazoxanide (Netazox® 500 mg) during 14 days
Telmisartan
EXPERIMENTALPatients in this arm will receive telmisartan (Micardis® 20 mg) during 10 days
Fluoxétine and Budésonide
EXPERIMENTALPatients in this arm will receive the combination of Fluoxétine (Fluoxétine Arrow® 40 mg ) / Budésonide (Budecort® 2\*400 mcg) during 7 days
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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%.
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ANRS, Emerging Infectious Diseaseslead
- University of Bordeauxcollaborator
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
- PACCI Programcollaborator
- Alliance for International Medical Actioncollaborator
- Centre Murazcollaborator
- Barcelona Institute for Global Healthcollaborator
Study Sites (2)
Centre Muraz/INSP
Bobo-Dioulasso, Burkina Faso
Centre de traitement des maladies à tendance épidémique de Gbessia
Conakry, Guinea
Related Publications (1)
Doucet MH, Songbono CT, Plazy M, Martin C, Fritzell C, Sow MS, Traore FA, Jaspard M, Poda A, Malvy D, Marcy O, Delamou A, Orne-Gliemann J. Perceptions of COVID-19 among communities of Conakry (Guinea): a qualitative study exploring the context of the ANRS COV33 Coverage-Africa therapeutic trial. BMJ Open. 2022 Dec 27;12(12):e061715. doi: 10.1136/bmjopen-2022-061715.
PMID: 36574985DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Investigators and all the staff in clinical sites will not be masked. Data manager and statician will not be masked too. However, the sponsor will be masked.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2021
First Posted
June 10, 2021
Study Start
April 12, 2021
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
January 31, 2023
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will share