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Hydroxychloroquine treating novel coronavirus pneumonia (COVID-19): a randomized controlled, open label, multicenter trial

Hydroxychloroquine treating novel coronavirus pneumonia (COVID-19): a randomized controlled, open label, multicenter trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029868
Enrollment
Unknown
Registered
2020-02-15
Start date
2020-02-11
Completion date
Unknown
Last updated
2020-03-23

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:oral hydroxychloroquine sulfate tablets
Control group:Conventional treatment meet the Guideline

Sponsors

Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 18 years old and above; 2. Meet the novel coronavirus pneumonia (COVID-19) diagnostic criteria. The upper and lower respiratory tract RT-PCR confirmed that 2019-nCoV nucleic acid positive, chest CT imaging examination could be used in conjunction; 3. SaO2/SpO2=94% under indoor air, or PaO2/FiO2<300mgHg (for severe type patients); 4. Sign informed consent; 5. Do not participate in the clinical study of other study drugs within 28 days.

Exclusion criteria

Exclusion criteria: 1. Aged less than 18 years old; 2. Other serious medical diseases such as malignant tumor, heart, liver and kidney disease, uncontrollable metabolic disease, etc; 3. Not suitable for gastrointestinal administration; 4. Pregnant or lactating women; 5. Those who are allergic to the ingredients of this product; 6. Mental state can not cooperate with the observer or cognitive impairment; 7. Severe liver disease (such as child Pugh score >=C, AST > 5 times ULN); 8. Patients with known severe renal impairment (creatinine clearance rate <=30 ml/min) or continuous renal replacement therapy, hemodialysis, peritoneal dialysis.

Design outcomes

Primary

MeasureTime frame
Viral nucleic acid test;

Countries

China

Contacts

Public ContactGuochao Shi

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

shi_guochao2010@qq.com+86 13918462035

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026