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Completed

NCT Number: NCT04261517

Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19

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

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Key information

Conditions

Pneumonia, Pneumocystis Bacterial Infections and Mycoses COVID-19 Coronaviridae Infections Coronavirus Coronavirus Infections Infections Lung Diseases Lung Diseases, Fungal Mycoses Nidovirales Infections Pneumocystis Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai Public Health Clinical Center, Shanghai, Shanghai Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydroxychloroquine

Drug

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

Primary outcomes

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

    Time frame: 3 days after randomization

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

    Time frame: 5 days after randomization

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

    Time frame: 7 days after randomization

  4. The mortality rate of subjects at weeks 2

    Time frame: 14 days after randomization

Secondary outcomes

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

    Time frame: 14 days after randomization

  2. The critical illness rate of subjects at weeks 2

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shanghai Public Health Clinical Center

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 7, 2020
Registry last updated
Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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