COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49420

Jin Ronghua

jin_eagle@sina.com

2020-03-24

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. male and female aged 18-70 years, 2. positive result of test for 2019 novel coronavirus nucleic acid, 3. Clinical diagnosed with pneumonia, 4. onset within 7 days (severe cases can be delayed to 14 days), 5. the informed consent shall be signed by me or the authorized agent, 6. subjects who can take oral medication or who receive oral medication, 7. agree to collect clinical samples, 8. female subjects of child-bearing age are not pregnant and agree to take effective contraceptive measures within 7 days of the last oral medication to ensure that they are not pregnant, 9. men agree not to have sex with women for seven days after their last oral medication.

1. severe vomiting and difficulty in taking oral medication or in taking oral medication, 2. pregnant and nursing women, 3. subjects received lopinavir/ridonavir, ribavirin, monoclonal antibodies and other specific antiviral drugs in the week prior to admission, 4. cases of respiratory failure requiring mechanical ventilation, 5. cases of shock, 6. combined with other organ failure requires intensive care unit, 7. patients with no clinical expectation of survival and only end-of-life care, or those in a deep coma who did not respond to supportive treatment within three hours of admission.

2

Beijing you'an Hospital; Capital Medical University

18

70

China

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

300

Clearance time of virus RNA;

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

Phase 2

[{"arm_notes": "", "treatment_id": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]