COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=134505

Ke Hu

huke-rmhospital@163.com

2021-09-30

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. Male and female, aged 18-70 years, 2. Novel coronavirus nucleic acid test positive, 3. The diagnostic criteria for confirmed cases in the national COVID-19 Protocol (Eighth edition) were met, 4. Onset within 7 days (severe cases can be extended to less than 10 days), 5. The informed consent is signed by patients or their authorized agent, 6. Subjects who may or receive oral medication, 7. Agree to collect clinical samples, 8. Female subjects of reproductive age were not pregnant and agreed to use effective contraception within 7 days of the last oral medication to ensure non-pregnancy, 9. The men agreed not to cohabit with the woman for seven days after the last oral medication.

1. Severe vomiting and difficulty in taking or ingestion of oral medication, 2. Pregnant and lactating women, 3. People with mental illness and cognitive impairment, 4. Subjects received antiviral drugs (including interferon-alpha, ribavirin, chloroquine phosphate, Abidol, remdesivir, lopinavir/ritonavir, monoclonal antibodies) in the week before admission, 5. Cases of respiratory failure requiring mechanical ventilation, 6. There were cases of shock, 7. ICU care is required for other organ failure, 8. Patients who were clinically predicted to have no hope of survival and were placed on hospice care only, or those who were in a deep coma and did not respond to supportive treatment within three hours of admission.

2

Renmin Hospital of Wuhan University

18

70

China

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

60

Time for viral nucleic acid to turn negative;

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

Phase 3

[{"arm_notes": "Oral+inhaled", "treatment_id": 2020, "treatment_name": "Interferon alpha+leflunomide", "treatment_type": "Interferons+other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Inhaled", "treatment_id": 664, "treatment_name": "Interferon alpha", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}]