Prevention and treatment for COVID-19 associated severe pneumonia in the Gambia (PaTS-COVID-19), a single-blinded randomized clinical trial: study protocol

Effua Usuf ORCID logo ; Helen Brotherton ORCID logo ; Behzad Nadjm ; Nuredin Mohammed ORCID logo ; Abdou Gai ; Fatoumata Sillah ; Mary Grey Johnson ; Chiquita Joquina Jones ; Catherine Sarr ; Hakeem Edun Babatunde ; +13 more... Abul Khalie Mohammad ; Bakary Dibba ; Ebrahim Ndure ; Lamin Bojang ; Saffiatou Darboe ; Alasana Bah ; Abdoulie Bojang ; Karen Forrest ; Davis Nwakanma ; Charles Roberts ; Bittaye Mustapha ; Umberto D’Alessandro ; Anna Roca ; (2023) Prevention and treatment for COVID-19 associated severe pneumonia in the Gambia (PaTS-COVID-19), a single-blinded randomized clinical trial: study protocol. International Journal of Clinical Trials, 10 (1). pp. 26-33. ISSN 2349-3240 DOI: 10.18203/2349-3259.ijct20230048
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Background: The coronavirus disease (COVID-19) pandemic resulted in an unprecedent global response for the development of COVID-19 vaccines. However, as viral mutations continue to occur, potentially decreasing the efficacy of currently available vaccines, and inequity of vaccine access continues, identifying safe and effective drugs to minimise severity of COVID-19 disease remains a priority. Methods: We designed an adaptive individually randomised single blinded non identical placebo-controlled trial to evaluate the safety and efficacy of repurposing licenced treatments for COVID-19 patients in an African setting. The trial has two cohorts: Cohort 1 recruits mild and moderate COVID-19 cases and their household contacts. Cases are actively followed up for 14 days, with a final visit at day 28. There are two co-primary endpoints: clinical progression to severe-pneumonia and persistence of the virus at day 14. The primary endpoint for household contacts is infection during a 14-day follow-up period. Cohort 2 recruits hospitalized patients with severe COVID-19 associated pneumonia followed up actively until discharge or death, and passively until day 90, with a final visit. The primary endpoint is clinical progression or death. Conclusions: This randomised trial will contribute African-specific data to the global response to COVID-19. Besides the efficacy of drugs on clinical progression, the trial will provide information on the dynamics of intra-household transmission. Trial registration: This study is registered with Clinical Trials.gov with registration number NCT04703608 and with Pan African clinical trials registry with registration number PACTR202101544570971.


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