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

Authors

  • Effua Usuf Disease Control & Elimination, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia https://orcid.org/0000-0002-6515-7186
  • Helen Brotherton Disease Control & Elimination, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia
  • Behzad Nadjm Clinical Service Department, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia
  • Nuredin Mohammed Department of Data Management, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia
  • Abdou Gai Department of Data Management, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia
  • Fatoumata Sillah Disease Control & Elimination, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia
  • Mary Grey Johnson Disease Control & Elimination, Medical Research Council Unit, Theambia at Londo Gn School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia
  • Chiquita Joquina Jones Disease Control & Elimination, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia
  • Catherine Sarr Disease Control & Elimination, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia
  • Hakeem Edun Babatunde Disease Control & Elimination, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia
  • Abul Khalie Mohammad Disease Control & Elimination, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia
  • Bakary Dibba Disease Control & Elimination, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia
  • Ebrahim Ndure Department of Data Management, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia
  • Lamin Bojang Department of Data Management, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia
  • Saffiatou Darboe Disease Control & Elimination, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia
  • Alasana Bah Disease Control & Elimination, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia
  • Abdoulie Bojang Disease Control & Elimination, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia
  • Karen Forrest Clinical Service Department, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia
  • Davis Nwakanma Disease Control & Elimination, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia
  • Charles Roberts Department of Surgery, Edward Francis Small Teaching Hospital, Banjul, BCC, The Gambia
  • Bittaye Mustapha Ministery of Health, Banjul, BCC, The Gambia
  • Umberto D’Alessandro Disease Control & Elimination, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia
  • Anna Roca Disease Control & Elimination, Medical Research Council Unit, The Gambia at London School of Hygiene & Tropical Medicine, Fajara, KMC, The Gambia

DOI:

https://doi.org/10.18203/2349-3259.ijct20230048

Keywords:

COVID-19, Mild- moderate- severe- pneumonia, Africa, Gambia, Ivermectin, Aspirin, Transmission

Abstract

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 randomized 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 randomized 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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Published

2023-01-23