Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19

COVID-19 Clinical Trial

Official title:

Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04261517
• Other study ID #: HC-COVID-19
• Status: Completed
• Phase: Phase 3
• Start date: February 6, 2020
• Est. completion date: February 25, 2020

Study information

• Verified date: April 2020
• Source: Shanghai Public Health Clinical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 25, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• COVID-19
• Pneumonia
• Pneumonia, Pneumocystis

Intervention

Drug:
• Hydroxychloroquine
Subjects take hydroxychloroquine 400 mg per day for 5 days, also take conventional treatments

Locations

Country	Name	City	State
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Public Health Clinical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3		3 days after randomization
Primary	The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5		5 days after randomization
Primary	The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7		7 days after randomization
Primary	The mortality rate of subjects at weeks 2		14 days after randomization
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0		14 days after randomization
Secondary	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

External Links

•   The results have been published on the Journal of Zhejiang University (Medical Sciences)