Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19

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

Detailed Description
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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.

Official Title
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Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19

Conditions
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Pneumonia, Pneumocystis, Coronavirus, COVID-19

Intervention / Treatment
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* Drug: Hydroxychloroquine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxychloroquine and conventional treatments<br>After randomization, subjects take hydroxychloroquine 400mg per day for 5 days, also take conventional treatments. | Drug: Hydroxychloroquine<br>* Subjects take hydroxychloroquine 400 mg per day for 5 days, also take conventional treatments<br>|
| No Intervention: Conventional treatments<br>After randomization, subjects take conventional treatments without hydroxychloroquine. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 |  | 3 days after randomization | 
| The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5 |  | 5 days after randomization | 
| The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 |  | 7 days after randomization | 
| The mortality rate of subjects at weeks 2 |  | 14 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |  | 14 days after randomization | 
| 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. | 14 days after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumonia, COVID-19, hydroxychloroquine