Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19

Phase 3

Completed

• Conditions: Pneumonia, Pneumocystis; COVID-19; Coronavirus
• Interventions: Drug: Hydroxychloroquine

• Registration Number: NCT04261517
• Lead Sponsor: Shanghai Public Health Clinical Center

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 Timeline

• Study Start: 2020-02-06
• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-07
• Primary Completion: 2020-02-25
• Study Completion: 2020-02-25
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-09
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydroxychloroquine and conventional treatments	Hydroxychloroquine	After randomization, subjects take hydroxychloroquine 400mg per day for 5 days, also take conventional treatments.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Shanghai Public Health Clinical Center; 🇨🇳 Shanghai, Shanghai, China