Cancelled due to lack of patient Clinical study for the effect and

A randomized, open-label, controlled trial for the efficacy and safety of hydroxychloroquine sulfate tablets in the treatment of patients with severe novel coronavirus pneumonia (COVID-19)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000029762

Enrollment

Unknown

Registered

2020-02-12

Start date

2020-02-12

Completion date

Unknown

Last updated

2020-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Experimental group:Conventional treatent and hydroxychloroquine

Control group:Conventional treatment

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Subjects who meet the following conditions can become subjects of this study: 1. Sign written informed consent. Adolescents or patients who cannot sign informed consent must obtain informed consent from the guardian; 2. Chinese aged >=18 years; 3. It complies with the NCP Critical and Critical Diagnostic Standards, namely "Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5). Combined with the following epidemiological history, clinical manifestations, and pathogenic examinations to make a comprehensive judgment. 4. The course of disease is within 14 days after the onset of illness; 5. Will take nasopharyngeal or oropharyngeal swabs before administration.

Exclusion criteria

Exclusion criteria: Patients with any of the following were excluded from the study: 1. Patients with previous allergy to 4-aminoquinoline compounds; 2. Patients with previous severe retinal or visual field related diseases; 3. Patients with severe liver damage; 4. Patients with impaired renal function (creatinine clearance <=50 mL / min); 5. Patients weighing <35kg; 6. Patients exposed to other study drugs within 30 days before administration; 7. Being pregnant or breastfeeding. Or have a pregnancy plan (including partner) within one month.

Design outcomes

Primary

Measure	Time frame
Negative conversion rate of COVID-19 nucleic acid;Lung inflammation absorption ratio;	—

Secondary

Measure	Time frame
Time for body temperature to return to normal;Time of improvement in respiratory symptoms;Proportion of severe to light;All-cause mortality;Days in hospital;Duration of non-invasive / invasive ventilation;Frequency of serious adverse events;	—

Countries

China

Contacts

Public ContactWenxiang Huang

The First Affiliated Hospital of Chongqing Medical University

wenxiang_huang@163.com+86 13883533808

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026