COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49869

Yin Zhenyu

Yinzy@xmu.edu.cn

2020-02-22

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. Aged 18-75 years old, 2. RT-PCR positive for 2019-nCoV or Confirmed lung involvement with chest imaging, 3. The clinical symptoms are slight, and there is no obvious manifestation of pneumonia (mild disease) or clinical symptoms such as fever and respiratory tract in imaging. The manifestation of pneumonia (common type) can be seen in imaging, 4. <=7 days since onset of the disease, 5. Willingness of study participant to accept randomization to any assigned treatment arm, 6. Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study.

1. Investigator makes a decision that trial participation is not in patients' best interest, or any condition that does not allow the protocol to be followed safely, 2. As judged by investigator historic or current diseases that may have impact on the subjects participation of the study or the study outcome. These diseases include but not limited to cadiac diease and arrhythmia and QT prolongation), neurological disease psychiatric disease,active bleeding, serious malnutrition and endocrine disease, currently complicated with serious respiratory disease or that seriously affect immune system, such as flu, COPD, asthma, HIV infection, blood system disease, or splenectomy, organ transplantation etc., 3. Severe liver disease (AST>3 ULN), 4. Patients with known severe renal impairment (estimated glomerular filtration rate <=60 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis, 5. QT elongation, 6. Allergic to chloroquine or hydroxychloroquine, 7. Pregnant or breastfeeding, or positive pregnancy test in a predose examination, 8. Will be transferred to another hospital within 72 hours, 9. Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 14 days prior to the time of the screening evaluation.

3

Zhongshan Hospital Affiliated to Xiamen University

18

75

China

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

100

Clinical recovery time;

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 0

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"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"}]