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Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19

Primary Purpose

Pneumonia, Pneumocystis, Coronavirus, COVID-19

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Hydroxychloroquine
Sponsored by
Shanghai Public Health Clinical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Pneumocystis focused on measuring Pneumonia, COVID-19, hydroxychloroquine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Public Health Clinical Center
  • Shanghai Public Health Clinical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hydroxychloroquine and conventional treatments

Conventional treatments

Arm Description

After randomization, subjects take hydroxychloroquine 400mg per day for 5 days, also take conventional treatments.

After randomization, subjects take conventional treatments without hydroxychloroquine.

Outcomes

Primary Outcome Measures

The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7
The mortality rate of subjects at weeks 2

Secondary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
The critical illness rate of subjects at weeks 2
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.

Full Information

First Posted
February 6, 2020
Last Updated
April 9, 2020
Sponsor
Shanghai Public Health Clinical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04261517
Brief Title
Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19
Official Title
Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 6, 2020 (Actual)
Primary Completion Date
February 25, 2020 (Actual)
Study Completion Date
February 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Public Health Clinical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumocystis, Coronavirus, COVID-19
Keywords
Pneumonia, COVID-19, hydroxychloroquine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydroxychloroquine and conventional treatments
Arm Type
Experimental
Arm Description
After randomization, subjects take hydroxychloroquine 400mg per day for 5 days, also take conventional treatments.
Arm Title
Conventional treatments
Arm Type
No Intervention
Arm Description
After randomization, subjects take conventional treatments without hydroxychloroquine.
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
Subjects take hydroxychloroquine 400 mg per day for 5 days, also take conventional treatments
Primary Outcome Measure Information:
Title
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3
Time Frame
3 days after randomization
Title
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5
Time Frame
5 days after randomization
Title
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7
Time Frame
7 days after randomization
Title
The mortality rate of subjects at weeks 2
Time Frame
14 days after randomization
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
14 days after randomization
Title
The critical illness rate of subjects at weeks 2
Description
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.
Time Frame
14 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201508
Country
China
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32391667
Citation
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.
Results Reference
derived
Links:
URL
http://www.zjujournals.com/med/CN/10.3785/j.issn.1008-9292.2020.03.03
Description
The results have been published on the Journal of Zhejiang University (Medical Sciences)

Learn more about this trial

Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19

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