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

How to Cite

Usuf, E., Brotherton, H., Nadjm, B., Mohammed, N., Gai, A., Sillah, F., Johnson, M. G., Jones, C. J., Sarr, C., Babatunde, H. E., Mohammad, A. K., Dibba, B., Ndure, E., Bojang, L., Darboe, S., Bah, A., Bojang, A., Forrest, K., Nwakanma, D., Roberts, C., Mustapha, B., D’Alessandro, U., & Roca, A. (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), 26–33. https://doi.org/10.18203/2349-3259.ijct20230048