Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19

Sponsor

Shanghai Public Health Clinical Center (Other)

Overall Status

Completed

CT.gov ID

NCT04261517

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Days)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Feb 6, 2020

Actual Primary Completion Date :

Feb 25, 2020

Actual Study Completion Date :

Feb 25, 2020

Arms and Interventions

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.

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

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.