Efficacy of hydroxychloroquine in patients with COVID-19: results of a randomized clinical trial

  1. Zhaowei Chen
  2. Jijia Hu
  3. Zongwei Zhang
  4. Shan Jiang
  5. Shoumeng Han
  6. Dandan Yan
  7. Ruhong Zhuang
  8. Ben Hu
  9. Zhan Zhang

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Abstract

Aims

Studies have indicated that chloroquine (CQ) shows antagonism against COVID-19 in vitro. However, evidence regarding its effects in patients is limited. This study aims to evaluate the efficacy of hydroxychloroquine (HCQ) in the treatment of patients with COVID-19.

Main methods

From February 4 to February 28, 2020, 62 patients suffering from COVID-19 were diagnosed and admitted to Renmin Hospital of Wuhan University. All participants were randomized in a parallel-group trial, 31 patients were assigned to receive an additional 5-day HCQ (400 mg/d) treatment, Time to clinical recovery (TTCR), clinical characteristics, and radiological results were assessed at baseline and 5 days after treatment to evaluate the effect of HCQ.

Key findings

For the 62 COVID-19 patients, 46.8% (29 of 62) were male and 53.2% (33 of 62) were female, the mean age was 44.7 (15.3) years. No difference in the age and sex distribution between the control group and the HCQ group. But for TTCR, the body temperature recovery time and the cough remission time were significantly shortened in the HCQ treatment group. Besides, a larger proportion of patients with improved pneumonia in the HCQ treatment group (80.6%, 25 of 31) compared with the control group (54.8%, 17 of 31). Notably, all 4 patients progressed to severe illness that occurred in the control group. However, there were 2 patients with mild adverse reactions in the HCQ treatment group. Significance: Among patients with COVID-19, the use of HCQ could significantly shorten TTCR and promote the absorption of pneumonia.

Significance

Among patients with COVID-19, the use of HCQ could significantly shorten TTCR and promote the absorption of pneumonia.

Trial registration

URL: https://www.clinicaltrials.gov/ . The unique identifier: ChiCTR2000029559.

Article activity feed

  1. ScreenIT

    SciScore for 10.1101/2020.03.22.20040758: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: Study design and participants: The clinical research protocol was reviewed and approved by the Ethics Committee in Renmin Hospital of Wuhan University (Wuhan, China).
    Consent: Informed consent was obtained from all patients.
    Randomization62 patients who met the trial criteria were randomly assigned in a to two groups, all received the standard treatment (oxygen therapy, antiviral agents, antibacterial agents, and immunoglobulin, with or without corticosteroids), patients in the HCQ treatment group received additional oral HCQ (hydroxychloroquine sulfate tablets, Shanghai Pharma) 400 mg/d (200 mg/bid) between days 1 and 5 (Figure 1), patients in the control group with the standard treatment only.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistical analyses were performed using Graphpad Prism, version 6.0.
    Graphpad Prism
    suggested: (GraphPad Prism, RRID:SCR_002798)

    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. ScreenIT

    SciScore for 10.1101/2020.03.22.20040758: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementMaterials and Methods Study design and participants The clinical research protocol was reviewed and approved by the Ethics Committee in Renmin Hospital of Wuhan University (Wuhan, China).Randomization62 patients who met the trial criteria were randomly assigned in a to two groups, all received the standard treatment (oxygen therapy, antiviral agents, antibacterial agents, and immunoglobulin, with or without corticosteroids), patients in the HCQ treatment group received additional oral HCQ (hydroxychloroquine sulfate tablets, Shanghai Pharma) 400 mg/d (200 mg/bid) between days 1 and 5 (Figure 1), patients in the control group with the standard treatment only.Blindingnot detected.Power Analysisnot detected.Sex as a biological variableAs shown in Table 1, For all patients, the age was 44.7 (15.3) years old, 46.8% (29 of 62) were male and 53.2% (33 of 62) were female.

    Table 2: Resources

    Antibodies
    SentencesResources
    For this, IL-6 antibody blocker, transfusion of convalescent plasma, and other therapies have been applied to counteract the cytokine storm [19,20].
    IL-6
    suggested: None
    Software and Algorithms
    SentencesResources
    Statistical analyses were performed using Graphpad Prism, version 6.0.
    Graphpad Prism
    suggested: (GraphPad Prism, SCR_002798)

    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).

    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 is not a substitute for expert review. SciScore checks for the presence and correctness of RRIDs (research resource identifiers) in the manuscript, and detects sentences that appear to be missing RRIDs. SciScore also checks to make sure that rigor criteria are addressed by authors. It does this by detecting sentences that discuss criteria such as blinding or power analysis. SciScore does not guarantee that the rigor criteria that it detects are appropriate for the particular study. Instead it assists authors, editors, and reviewers by drawing attention to sections of the manuscript that contain or should contain various rigor criteria and key resources. For details on the results shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2020.03.22.20040758v3 on medRxiv
  4. Version published to 10.1101/2020.03.22.20040758v2 on medRxiv
  5. Version published to 10.1101/2020.03.22.20040758v1 on medRxiv