Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19

Shanghai Public Health Clinical Center30 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pneumonia, Pneumocystis Coronavirus COVID-19

Interventions

HydroxychloroquineDRUG

Subjects take hydroxychloroquine 400 mg per day for 5 days, also take conventional treatments

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3

Time frame: 3 days after randomization

The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5

Time frame: 5 days after randomization

The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7

Time frame: 7 days after randomization

The mortality rate of subjects at weeks 2

Time frame: 14 days after randomization

Secondary Outcomes

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time frame: 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.

Time frame: 14 days after randomization

Data from ClinicalTrials.gov

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