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Clinical Study of Chloroquine Phosphate in the Treatment of Severe Novel Coronavirus Pneumonia (COVID-19)

Clinical Study of Chloroquine Phosphate in the Treatment of Severe Novel Coronavirus Pneumonia (COVID-19)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029988
Enrollment
Unknown
Registered
2020-02-18
Start date
2020-02-13
Completion date
Unknown
Last updated
2020-02-25

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

Sponsors

Zhongnan Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Male and female, 18-70 years old; 2) Severe patients (in any case: respiratory distress, RR >= 30 times / min; in resting state, oxygen saturation <= 93%; PaO2 / FiO2 <= 300MMHG); 3) Within 12 days after illness onset; 4) Agree to sign the informed consent; 5) Able to ingest, absorb and tolerate oral medication; 6) Agree to collect clinical samples; 7) Consent to contraceptive measures for sex within 7 days of the last oral medication.

Exclusion criteria

Exclusion criteria: 1) Cases with severe vomiting and difficulty in taking drugs orally or causing difficulty in taking drugs after oral administration; 2) Pregnant and lactating women; 3) The subjects received specific antiviral drugs such as lopinavir / lidonavir, ribavirin and monoclonal antibody within one week before admission; 4) Cases with no hope of survival, hospice care only, or deep coma and no response to supportive treatment within three hours after admission; 5) Cases of deep shock and respiratory failure; 6) Severe liver diseases (such as child Pugh score >= C, AST more than 5 times of the upper limit of normal); 7) Patients with severe renal insufficiency (estimated glomerular filtration rate <= 30ml / min / 1.73m2) or undergoing continuous renal replacement therapy, hemodialysis, peritoneal dialysis; 8) Patients with known allergic reactions or contraindications to chloroquine phosphate; 9) The doctor decided that it was not in the best interests of the subjects to participate in the study, or there was any situation in which the agreement could not be followed safely.

Design outcomes

Primary

MeasureTime frame
Time to Clinical Recovery;

Secondary

MeasureTime frame
All cause mortality;Length-of-stay in hospital;Length-of-stay in ICU;Days of mechanical ventilation;Modified BAP-65 and DECAF score;

Countries

China

Contacts

Public ContactZhao Yan

Zhongnan Hospital of Wuhan University

doctoryanzhao@whu.edu.cn+86 13995577963

Outcome results

None listed

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