Prevention and treatment for COVID-19 associated severe pneumonia in the Gambia (PaTS-COVID-19), a single-blinded randomized clinical trial: study protocol
DOI:
https://doi.org/10.18203/2349-3259.ijct20230048Keywords:
COVID-19, Mild- moderate- severe- pneumonia, Africa, Gambia, Ivermectin, Aspirin, TransmissionAbstract
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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References
Covid-19 infection. Available at: https://www. worldometers.info/coronavirus/. Accessed on 20 November 2022.
Weekly bulletin on outbreaks and other emergencies. Available at: https://www.afro.who.int/health-topics/disease-outbreaks/outbreaks-and-other-emergencies-updates. Accessed on 20 November 2021.
Martinez-Alvarez M, Jarde A, Usuf E. COVID-19 pandemic in west Africa. Lancet Glob Health. 2020; 8(5):e631-2.
Tackling the Coronavirus (COVID-19): West African perspectives. Available at: https://www. oecd.org/swac/coronavirus-west-africa/. Accessed on 20 November 2021.
Abatan B, Agboghoroma O, Akemoke F. Intense and mild first epidemic wave of coronavirus disease, The Gambia. Emerg Infect Dis. 2021;27(8):2064-72.
Clinical Trials. Available at: https://clinicaltrials. gov/ct2/results?cond=covid&term=&cntry=&state=&city=&dist=. Accessed on 20 November 2021.
Group RC, Horby P, Lim WS. Dexamethasone in Hospitalized Patients with Covid-19. N Engl J Med. 2021;384(8):693-704.
Brotherton H, Usuf E, Nadjm B, et al. Dexamethasone for COVID-19: data needed from randomised clinical trials in Africa. Lancet Glob Health. 2020;8(9):e1125-e6.
Touray S, Sanyang B, Zandrow G, et al. An assessment of critical care capacity in the Gambia. J Crit Care. 2018;47:245-53.
Recent macroeconomic and financial developments. Available at: https://www.afdb.org/en/ countries/ west-africa/gambia/gambia-economic-outlook. Accessed on 20 November 2021.
Diallo BA, Usuf E, Ceesay O, D'Alessandro U, Roca A, Martinez-Alvarez M. Clinical research on COVID-19: perceptions and barriers to participation in The Gambia. BMJ Glob Health. 2022;7(2):23-8.
Dabira ED, Soumare HM, Lindsay SW, et al. Mass drug administration with high-dose ivermectin and dihydroartemisinin-piperaquine for malaria elimination in an area of low transmission with high coverage of malaria control interventions: protocol for the MASSIV cluster randomized clinical trial. JMIR Res Protoc. 2020;9(11):e20904.
Ranjbar K, Moghadami M, Mirahmadizadeh A. Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial. BMC Infect Dis. 2021; 21(1):337.
Clinical Trials. Available at: https://clinicaltrials. gov/ct2/show/NCT04343001?term=CRASH+19&draw=2&rank=1. Accessed on 20 November 2021.
Clinical Managament of COVID-19 Interim guidance. Available at: https://apps.who.int/ iris/handle/10665/332196. Accessed on 20 November 2021.
Bosch F, Palmeirim MS, Ali SM, Ame SM, Hattendorf J, Keiser J. Diagnosis of soil-transmitted helminths using the Kato-Katz technique: What is the influence of stirring, storage time and storage temperature on stool sample egg counts? PLoS Negl Trop Dis. 2021;15(1):e0009032.
Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999;54(7): 581-6.
CONSORT 2020. Available at: www.consort-statement.org. Accessed on 20 November 2021.
Knight SR, Ho A, Pius R. Risk stratification of patients admitted to hospital with covid-19 using the ISARIC WHO clinical characterisation protocol: development and validation of the 4C Mortality Score. BMJ. 2020;370:3339.
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