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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|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.|
|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|
Active Comparator: Paracetamol
Patients in this arm will receive paracetamol 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
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.
Patients in this arm will receive telmisartan (Micardis® 20 mg) during 10 days
Drug: Telmisartan 20Mg Oral Tablet
20 mg tablet daily
- 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.
- 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.
- 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.
- 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
- 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
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
|Contact: Olivier Marcy, Dr||+33 557 57 47 firstname.lastname@example.org|
|Contact: Camille Fritzell, Dr||+33 557 57 47 email@example.com|
|Centre Muraz/INSP||Not yet recruiting|
|Bobo-Dioulasso, Burkina Faso|
|Contact: Armel Poda, Pr. 65314949 ext +226 firstname.lastname@example.org|
|Contact: Apoline Sondo, Pr 70077198 ext +226 email@example.com|
|Centre de traitement des maladies à tendance épidémique de Gbessia||Recruiting|
|Contact: Mamadou Sow, Pr 622 913 830 ext +224 firstname.lastname@example.org|
|Contact: Fodé Bangali Sako, Pr email@example.com|