Back to resultsEarly Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection (COVERAGE-A)
Primary Purpose
Covid19, Covid19 Drug Treatment, Severe Acute Respiratory Syndrome Coronavirus 2
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nitazoxanide and Ciclésonide
Telmisartan 20Mg Oral Tablet
Paracetamol
Fluoxétine and Budésonide
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
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
Sites / Locations
- Centre Muraz/INSPRecruiting
- Centre de traitement des maladies à tendance épidémique de Gbessia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Paracetamol
Nitazoxanide and Ciclésonide
Telmisartan
Fluoxétine and Budésonide
Arm Description
Patients in this arm will receive paracetamol during 14 days
Patients in this arm will receive the combination of ciclezonide (Alvesco® 160 µg ) / nitazoxanide (Netazox® 500 mg) during 14 days
Patients in this arm will receive telmisartan (Micardis® 20 mg) during 10 days
Patients in this arm will receive the combination of Fluoxétine (Fluoxétine Arrow® 40 mg ) / Budésonide (Budecort® 2*400 mcg) during 7 days
Outcomes
Primary Outcome Measures
SpO2 ≤ 93% within 14 days
Percentage of participant presenting an oxygen saturation percentage (SpO2) ≤ 93% or death within 14 days after randomization to treatment.
Death within 14 days
Percentage of participant dead within 14 days after randomization to treatment, including death for any reason.
Secondary Outcome Measures
Death within 28 days
Percentage of participant dead within 28 days after randomization to treatment, including death for any reason.
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
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
Full Information
NCT ID
NCT04920838
First Posted
May 4, 2021
Last Updated
January 30, 2023
Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
University of Bordeaux, Institut National de la Santé Et de la Recherche Médicale, France, PACCI Program, Alliance for International Medical Action, Centre Muraz, Barcelona Institute for Global Health
1. Study Identification
Unique Protocol Identification Number
NCT04920838
Brief Title
Early Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection
Acronym
COVERAGE-A
Official Title
Early Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection: A Multi-Arm Multi-Stage Randomized Trial (MAMS) to Evaluate the Effectiveness of Several Specific Treatments in Reducing the Risk of Clinical Worsening or Death in Sub-Saharan Africa (COVERAGE-Africa)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
University of Bordeaux, Institut National de la Santé Et de la Recherche Médicale, France, PACCI Program, Alliance for International Medical Action, Centre Muraz, Barcelona Institute for Global Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Covid19 Drug Treatment, Severe Acute Respiratory Syndrome Coronavirus 2, SARS-CoV2 Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This is a multicentre, multiple country, randomised, open-label, adaptive, platform clinical study aiming to determine the efficacy and safety of various treatment regimens for prevention of the need for hospitalisation for specialised care due to severe progression of COVID-19.
The study is designed with the ability to incorporate the adding or dropping of treatment arms and that will include similar inclusion and non-inclusion criteria, the same primary and secondary endpoints, common data entry procedures, a shared database and a single statistical methodology for analysis of the primary endpoint.
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Paracetamol
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive paracetamol during 14 days
Arm Title
Nitazoxanide and Ciclésonide
Arm Type
Experimental
Arm Description
Patients in this arm will receive the combination of ciclezonide (Alvesco® 160 µg ) / nitazoxanide (Netazox® 500 mg) during 14 days
Arm Title
Telmisartan
Arm Type
Experimental
Arm Description
Patients in this arm will receive telmisartan (Micardis® 20 mg) during 10 days
Arm Title
Fluoxétine and Budésonide
Arm Type
Experimental
Arm Description
Patients in this arm will receive the combination of Fluoxétine (Fluoxétine Arrow® 40 mg ) / Budésonide (Budecort® 2*400 mcg) during 7 days
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide and Ciclésonide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Telmisartan 20Mg Oral Tablet
Intervention Description
20 mg tablet daily
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Fluoxétine and Budésonide
Intervention Description
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.
Primary Outcome Measure Information:
Title
SpO2 ≤ 93% within 14 days
Description
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.
Title
Death within 14 days
Description
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.
Secondary Outcome Measure Information:
Title
Death within 28 days
Description
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.
Title
Occurence of at least one grade 3 or 4 clinical or biological adverse event within 14 days
Description
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.
Title
Number of hospitalizations due to severe progression
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier Marcy, Dr
Phone
+33 557 57 47 23
Email
olivier.marcy@u-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony L'Hostellier
Phone
+33 557 57 47 23
Email
anthony.lhostellier@u-bordeaux.fr
Facility Information:
Facility Name
Centre Muraz/INSP
City
Bobo-Dioulasso
Country
Burkina Faso
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armel Poda, Pr.
Phone
65314949
Ext
+226
Email
armelpoda@yahoo.fr
First Name & Middle Initial & Last Name & Degree
Apoline Sondo, Pr
Phone
70077198
Ext
+226
Email
sondoapoline@yahoo.fr
Facility Name
Centre de traitement des maladies à tendance épidémique de Gbessia
City
Conakry
Country
Guinea
Individual Site Status
Suspended
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Early Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection
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