COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49218

Zhao Yan

doctoryanzhao@whu.edu.cn

2020-02-18

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

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.

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.

2

Zhongnan Hospital of Wuhan University

18

70

China

Severe disease at enrollment

6: Severe disease at enrollment

80

Time to Clinical Recovery;

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 4

[{"arm_notes": "", "treatment_id": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]