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Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19

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ClinicalTrials.gov Identifier: NCT04261517
Recruitment Status : Completed
First Posted : February 7, 2020
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
Hongzhou Lu, Shanghai Public Health Clinical Center

Tracking Information
First Submitted Date  ICMJE February 6, 2020
First Posted Date  ICMJE February 7, 2020
Last Update Posted Date April 13, 2020
Actual Study Start Date  ICMJE February 6, 2020
Actual Primary Completion Date February 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
  • The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 [ Time Frame: 3 days after randomization ]
  • The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5 [ Time Frame: 5 days after randomization ]
  • The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 [ Time Frame: 7 days after randomization ]
  • The mortality rate of subjects at weeks 2 [ Time Frame: 14 days after randomization ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 14 days after randomization ]
  • The critical illness rate of subjects at weeks 2 [ Time Frame: 14 days after randomization ]
    The diagnosis of critical illness case was based on the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4) made by National Health Commission of the People's Republic of China.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19
Official Title  ICMJE Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19
Brief Summary The study aims to evaluate the efficacy and safety of hydroxychloroquine in the treatment of COVID-19 pneumonia.
Detailed Description There is no vaccine or antiviral treatment for human coronavirus, so this study aims to evaluate the efficacy and safety of hydroxychloroquine in the treatment of COVID-19 pneumonia.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pneumonia, Pneumocystis
  • Coronavirus
  • COVID-19
Intervention  ICMJE Drug: Hydroxychloroquine
Subjects take hydroxychloroquine 400 mg per day for 5 days, also take conventional treatments
Study Arms  ICMJE
  • Experimental: Hydroxychloroquine and conventional treatments
    After randomization, subjects take hydroxychloroquine 400mg per day for 5 days, also take conventional treatments.
    Intervention: Drug: Hydroxychloroquine
  • No Intervention: Conventional treatments
    After randomization, subjects take conventional treatments without hydroxychloroquine.
Publications * Chen J, Liu D, Liu L, Liu P, Xu Q, Xia L, Ling Y, Huang D, Song S, Zhang D, Qian Z, Li T, Shen Y, Lu H. [A pilot study of hydroxychloroquine in treatment of patients with moderate COVID-19]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2020 May 25;49(2):215-219. doi: 10.3785/j.issn.1008-9292.2020.03.03. Chinese.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 25, 2020
Actual Primary Completion Date February 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The participants were diagnosed as COVID-19 pneumonia, according to the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4 or update version) made by National Health Commission of the People's Republic of China;
  • Participants aged over 18;
  • Written the informed consent.

Exclusion Criteria:

  • Hypersensitivity to chloroquine or hydroxychloroquine;
  • Women during pregnancy;
  • Severe heart, lung, kidney, brain, blood diseases or other important systemic diseases;
  • Participants with retinal disease, hearing loss;
  • Participants with severe neurological and mental illness;
  • Subjects were considered to be unable to complete the study, or not suitable for the study by researchers.

Exit criteria:

  • Subjects asked to withdraw the study
  • Subject will benefit if withdraw according to researchers' suggestions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04261517
Other Study ID Numbers  ICMJE HC-COVID-19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hongzhou Lu, Shanghai Public Health Clinical Center
Study Sponsor  ICMJE Shanghai Public Health Clinical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai Public Health Clinical Center
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP