COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49574

Yin Zhenyu

Yinzy@xmu.edu.cn

2020-02-18

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. The age at the time of signing the informed consent is >= 18 years old and <= 75 years old, both male and female, 2. The change of typical viral pneumonia in lung was detected by RT-PCR test of novel coronavirus nucleic acids or lung CT, 3. SaO2 / SpO2 <= 94% or pa02 / fi02 ratio < 300mghg at room temperature at admission, 4. Onset <=12 days, 5. Willing to participate in the trial and randomly assigned to any treatment group, 6. Cannot participate in another experiment during the study period.

1. In the opinion of the researchers, the participation of the trial is not in the best interests of the patients, or any situation is not in line with the situation that the trial scheme is allowed to be followed safely, 2. According to the judgment of the investigator, the diseases previously or now may affect the patients' participation in the trial or the outcome of the study, including but not limited to: malignant tumors, autoimmune diseases, liver and kidney diseases, cardiovascular system diseases (including but not limited to having a clear history of heart disease, cardiac arrhythmia and ECG QT Patients with prolonged interval), nervous system diseases, mental system diseases, active bleeding, severe malnutrition and endocrine diseases, patients with severe respiratory system diseases or diseases seriously affecting the immune system, such as: influenza, COPD, asthma, human immunodeficiency virus (HIV) infection, or blood system diseases, or splenectomy, organ transplantation, etc., 3. Severe liver disease (AST > 3 times of upper limit), 4. Patients with known renal insufficiency (estimated glomerular filtration rate <= 60ml / min / 1.73 m2 or continuous renal replacement therapy, hemodialysis, peritoneal dialysis, 5. Extended QT interval in ECG, 6. Allergic to chloroquine or hydroxychloroquine, 7. Pregnant or lactating or positive pregnancy test during pre medication examination, 8. Transfer to another hospital within 72 hours, 9. Receive any trial treatment drug for 2019-ncov within 14 days prior to screening evaluation (off label, compassionate use or trial related).

3

Zhongshan Hospital Affiliated to Xiamen University

18

75

China

Severe disease at enrollment

6: Severe disease at enrollment

100

Clinical recovery time;Clinical recovery time;Changes in viral load of upper and lower respiratory tract samples compared with the baseline;

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

Phase 4

[{"arm_notes": "", "treatment_id": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "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"}]