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Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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Brief Summary:
The study aims to evaluate the efficacy and safety of hydroxychloroquine in the treatment of COVID-19 pneumonia.

Condition or disease Intervention/treatment Phase
Pneumonia, Pneumocystis Coronavirus COVID-19 Drug: Hydroxychloroquine Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19
Actual Study Start Date : February 6, 2020
Actual Primary Completion Date : February 25, 2020
Actual Study Completion Date : February 25, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Hydroxychloroquine and conventional treatments
After randomization, subjects take hydroxychloroquine 400mg per day for 5 days, also take conventional treatments.
 Drug: Hydroxychloroquine
Subjects take hydroxychloroquine 400 mg per day for 5 days, also take conventional treatments
No Intervention: Conventional treatments
After randomization, subjects take conventional treatments without hydroxychloroquine.


Outcome Measures
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Primary Outcome Measures :
  1. The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 [ Time Frame: 3 days after randomization ]
  2. The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5 [ Time Frame: 5 days after randomization ]
  3. The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 [ Time Frame: 7 days after randomization ]
  4. The mortality rate of subjects at weeks 2 [ Time Frame: 14 days after randomization ]

Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 14 days after randomization ]
  2. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04261517


Locations
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China, Shanghai
Shanghai Public Health Clinical Center
Shanghai, Shanghai, China, 201508
Shanghai Public Health Clinical Center
Shanghai, Shanghai, China
Sponsors and Collaborators
Shanghai Public Health Clinical Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hongzhou Lu, professor, Shanghai Public Health Clinical Center
ClinicalTrials.gov Identifier: NCT04261517    
Other Study ID Numbers: HC-COVID-19
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hongzhou Lu, Shanghai Public Health Clinical Center:
Pneumonia
COVID-19
hydroxychloroquine
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Pneumonia, Pneumocystis
Pneumonia, Viral
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
 Lung Diseases, Fungal
Mycoses
Bacterial Infections and Mycoses
Pneumocystis Infections
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents