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Early Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection (COVERAGE-A)

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ClinicalTrials.gov Identifier: NCT04920838
Recruitment Status : Recruiting
First Posted : June 10, 2021
Last Update Posted : June 10, 2021
Sponsor:
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
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

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 two assessed treatments are now the association of Ciclésonide / Nitazoxanide and the Telmisartan, 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 December 2021. 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.


Condition or disease Intervention/treatment Phase
Covid19 Covid19 Drug Treatment Severe Acute Respiratory Syndrome Coronavirus 2 SARS-CoV2 Infection Drug: Nitazoxanide and Ciclésonide Drug: Telmisartan 20Mg Oral Tablet Drug: Paracetamol Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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.
Primary Purpose: Treatment
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)
Actual Study Start Date : April 12, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Active Comparator: Paracetamol
Patients in this arm will receive paracetamol during 14 days
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


Experimental: Nitazoxanide and Ciclésonide
Patients in this arm will receive the combination of ciclezonide (Alvesco® 160 µg ) / nitazoxanide (Netazox® 500 mg) during 14 days
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.

Experimental: Telmisartan
Patients in this arm will receive telmisartan (Micardis® 20 mg) during 10 days
Drug: Telmisartan 20Mg Oral Tablet
20 mg tablet daily




Primary Outcome Measures :
  1. SpO2 ≤ 93% within 14 days [ Time Frame: From inclusion (day 0) to day 14. ]
    Percentage of participant presenting an oxygen saturation percentage (SpO2) ≤ 93% or death within 14 days after randomization to treatment.

  2. Death within 14 days [ Time Frame: From inclusion (day 0) to day 14. ]
    Percentage of participant dead within 14 days after randomization to treatment, including death for any reason.


Secondary Outcome Measures :
  1. Death within 28 days [ Time Frame: From inclusion (day 0) to day 28. ]
    Percentage of participant dead within 28 days after randomization to treatment, including death for any reason.

  2. 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. ]
    Occurence of at least one grade 3 or 4 clinical or biological adverse event within 14 days

  3. Number of hospitalizations due to severe progression [ Time Frame: From inclusion (day 0) to day 28. ]

    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • COVID-19 confirmed by molecular biology
  • 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
  • On-going treatment with Telmisartan
  • Chronic treatment with inhaled corticosteroids (up to 30 days)
  • Renal or hepatic failure or known history of renal or hepatic failure
  • Abnormal physical examination findings:

    • respiratory rate < 25 per minute;
    • blood pressure < 90/60 mmHg or > 160/100 mmHg;
  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04920838


Contacts
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Contact: Olivier Marcy, Dr +33 557 57 47 23 olivier.marcy@u-bordeaux.fr
Contact: Camille Fritzell, Dr +33 557 57 47 23 camille.fritzell@u-bordeaux.fr

Locations
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Burkina Faso
Centre Muraz/INSP Not yet recruiting
Bobo-Dioulasso, Burkina Faso
Contact: Armel Poda, Pr.    65314949 ext +226    armelpoda@yahoo.fr   
Contact: Apoline Sondo, Pr    70077198 ext +226    sondoapoline@yahoo.fr   
Guinea
Centre de traitement des maladies à tendance épidémique de Gbessia Recruiting
Conakry, Guinea
Contact: Mamadou Sow, Pr    622 913 830 ext +224    smsaliou@gmail.com   
Contact: Fodé Bangali Sako, Pr       sakofb@yahoo.fr   
Sponsors and Collaborators
ANRS, Emerging Infectious Diseases
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
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Responsible Party: ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier: NCT04920838    
Other Study ID Numbers: ANRS COV33 COVERAGE-Africa
First Posted: June 10, 2021    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Severe Acute Respiratory Syndrome
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Acetaminophen
Ciclesonide
Nitazoxanide
Telmisartan
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action