Safety and efficacy of pharmacotherapy used for the management of COVID 19: A systematic review and meta-analysis of randomized control trials

Sah, S. K.; Undela, K.; Chand, D. S.; Ramesh, M.; R, S.; Gona, O. J.; George, S. M.; UP, N.; Aryal, S.; P, N.; Shastry, C. S.

Background: COVID-19 is a novel coronavirus, which is highly contagious and a threat to human health, spreading across nearly 235 countries, affecting 33.8 million and causing 1.01 million fatalities as of 22 September 2020. Researchers have invested tremendous efforts to develop vaccines or effective drug therapy but have not yet been fruitful. Hence, we planned to conduct this systematic review and meta-analysis to supplement the readers with comprehensive data and credible information on the safety and efficacyof essential pharmacotherapy during the pharmacological management of COVID-19. Methods: Theprotocol will be designed based on the updated PRISMA-P 2015 guidelines. An elaborate search of electronic databases such as PubMed/Medline, Web of Science, Scopus, The Cochrane Library, ClinicalTrials.gov, Google Scholar, Medrxiv and other potential databases for articles published during January 2020 to 10 October 2020 is planned to be conducted. Following this,randomized control trials published in English language that assess the safety and efficacy of pharmacotherapy versusplacebo or standard of care or usual care will be evaluated for inclusion. The primary outcomes will include time to clinical recovery and the probability for the negative conversion of COVID-19. Secondary outcomes will quantifythe proportion of patients relieved of symptoms, the all-cause mortality, morbidity, detection of viral RNA, time needed to achieve a negative viral load, ordinal scale changes, ventilatorand oxygen requirements,length of hospital stayand the incidence of adverse and serious adverse events.RevMan V.5.3 computer software packages will be utilised to conduct an accurate statistical analysis of the study. Thebinary random-effects model will be used at a 95 % confidence interval to estimate the weighted effect size ofdichotomous data and continuous data studies. The results of statistical analysis will be considered statistically significant whena p-value <0.05 is attained. Results: Selected studies will be used to evaluate the safety and efficacy of pharmacotherapy used during the management of the novel COVID-19. Conclusion: This study will be a qualitative and quantitative pool of comprehensive evidence regarding the safety and efficacy of pharmacotherapy on COVID-19.