The race to find a SARS-CoV-2 drug can only be won by a few chosen drugs: a systematic review of registers of clinical trials of drugs aimed at preventing or treating COVID-19

  1. Vicente Martinez-Vizcaino
  2. Arthur E. Mesas
  3. Iván Cavero-Redondo
  4. Alicia Saz-Lara
  5. Irene Sequí-Dominguez
  6. Carlos Pascual-Morena
  7. Celia Álvarez-Bueno

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Abstract

Considering the massive amount of clinical trial registers aimed to find effective drugs for the prevention and treatment of COVID-19, it is challenging to have a comprehensive view of which drugs are being studied more extensively and when is expected that we will have consistent results regarding their effectiveness. This systematic review included all clinical trials on pharmacological therapy related to COVID-19 and SARS-CoV-2 registered at the International Clinical Trials Registry Platform (WHO-ICTRP) up to April 22, 2020. Clinical trials characteristics (country, design, sample size, main outcomes, expected completion data, type of participants, length of the interventions, main outcomes). How many trials and the accumulated sample size by drug or combination of drugs, and by month in 2020 was depicted. We identified 412 clinical trials registers addressing the effect of pharmacological treatments on COVID-19, predominantly from Asia and Europe (42.2% and 31.1% of clinical trials registers, respectively). The most main outcomes studied were clinical recovery (54.4% of the clinical trials registers, respiratory recovery (28.2%) mortality (27.4%), viral load/negativity (20.4%). During 2020, a huge amount of clinical trials are expected to be completed: 41 trials (60,366 participants) using hydroxychloroquine, 20 trials (1,588 participants) using convalescent’s plasma, 18 trials (6,830 participants) using chloroquine, 12 trials (9,938 participants using lopinavir/ritonavir, 11 trials (1,250 participants) using favipiravir, 10 trials (2,175 participants) using tocilizumab and 6 trials (13,540 participants) using Remdesivir. The distribution of the number of registered clinical trials among the different therapeutic options leads to an excess of sample size for some and a lack for others. Our data allow us to conclude that by the end of June we will have results of almost 20 trials involving 40000 patients for hydroxychloroquine and 5 trials with 4500 patients for remdesivir; however, low statistical power is expected from the 9 clinical trials testing the efficacy of favipiravir or the 5 testing tocilizumab, since they will recruit less than 1000 patients each one.

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  1. ScreenIT

    SciScore for 10.1101/2020.05.05.20091785: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: Thank you for sharing your data.

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Among the limitations of this study it should be acknowledged that: i) the quality of the registers has not been evaluated due to the lack of a reliable tool for this purpose; ii) although the WHO-ICTRP is the main database of clinical trial registers and collects most national and international databases, some trials registered in non-WHO-ICTRP databases may not have been included; iii) the information collected from each clinical trial register could be heterogeneous, because each database encodes the information differently; iv) because of the lack of quality in the description of the sources of funding in many registers, we have not examined the potential relationship between therapeutic options and public or private sponsors of the trials; and v) the figures provided relating number of trials with sample size estimated to be available during 2020 may be underestimated, because many registers do not indicate the estimated end date of the trial. In summary, regardless of whether it is financed by public or private resources, and especially in this pandemic crisis, research is a public good, and therefore has to be based on its scientific and social value, in order to produce the scientific evidence needed by the population, policy makers and, above all, clinicians [18]. For this reason, it is not justified that predictably by June more than 20 clinical trials enrolling tens of thousands of patients will finish their recruitment processes testing almost identical hypotheses...

    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 10.1101/2020.05.05.20091785 on medRxiv