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

  1. Sujit Kumar Sah
  2. Krishna Undela
  3. Sharad Chand
  4. Madhan Ramesh
  5. R Subramanian
  6. Oliver Joel Gona
  7. Sophia M. George
  8. UP Nandakumar
  9. Santosh Aryal
  10. P Niharika
  11. C.S. Shastry

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Abstract

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.

PROSPERO registration

CRD42020205433

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  1. ScreenIT

    SciScore for 10.1101/2020.10.02.20206045: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    RandomizationThe human studies (randomized control trials) published in English language that evaluated the safety and efficacy of pharmacotherapy versus placebo or standard of care or usual care will be considered for review as well.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Immunosupressive agents, glucocorticoids, dexamethasone, antirheumatic agents, tocilizumab, sarilumab, biological products, antibodies, monoclonal, anti-bacterial agents, azithromycin, nafamostat, camostat, nitazoxanide, famotidine, angiotensin-converting enzyme inhibitors, non-steroidal anti-inflammatory agents were some other key words that were used while probing the databases.
    dexamethasone , antirheumatic agents , tocilizumab , sarilumab , biological products ,
    suggested: None
    anti-bacterial agents , azithromycin , nafamostat , camostat , nitazoxanide , famotidine ,
    suggested: None
    Software and Algorithms
    SentencesResources
    Data sources: We will conduct a comprehensive search of electronic databases such as PubMed/Medline (https://www.ncbi.nlm.nih.gov/pubmed/), Web of Science (https://clarivate.com/web-of-science-core-collection/), Scopus (https://www.scopus.com/), The Cochrane Library (
    PubMed/Medline
    suggested: None
    Cochrane Library
    suggested: (Cochrane Library, RRID:SCR_013000)
    http://www.cochranelibrary.com/), ClinicalTrials.gov (https://www.clinicaltrials.gov/), Google Scholar (https://scholar.google.com/), Medrxiv (https://www.medrxiv.org/) and other potential databases.
    Google Scholar
    suggested: (Google Scholar, RRID:SCR_008878)
    The following search strategies will be adopted to search PubMed databases presented below: #1.
    PubMed
    suggested: (PubMed, RRID:SCR_004846)
    Search “drug therapy”[MeSH Terms] #2.
    MeSH
    suggested: (MeSH, RRID:SCR_004750)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  2. Version published to 10.1101/2020.10.02.20206045v2 on medRxiv
  3. Version published to 10.1101/2020.10.02.20206045v1 on medRxiv