Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19

NCT ID: NCT04261517

Last Updated: 2020-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-06

Study Completion Date

2020-02-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pneumonia, Pneumocystis Coronavirus COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hydroxychloroquine and conventional treatments

After randomization, subjects take hydroxychloroquine 400mg per day for 5 days, also take conventional treatments.

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

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

Conventional treatments

After randomization, subjects take conventional treatments without hydroxychloroquine.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hydroxychloroquine

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Public Health Clinical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hongzhou Lu

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Chen J, Liu D, Liu L, Liu P, Xu Q, Xia L, Ling Y, Huang D, Song S, Zhang D, Qian Z, Li T, Shen Y, Lu H. [A pilot study of hydroxychloroquine in treatment of patients with moderate COVID-19]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2020 May 25;49(2):215-219. doi: 10.3785/j.issn.1008-9292.2020.03.03. Chinese.

Reference Type DERIVED
PMID: 32391667 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.zjujournals.com/med/CN/10.3785/j.issn.1008-9292.2020.03.03

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HC-COVID-19

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.