COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49988

Liu Yingxia

yingxialiu@hotmail.com

2020-02-23

Recruiting

RCT

Randomized

Parallel

Not reported

single-center

Treatment

1. 16 to 75 years of age, male or female, 2. Respiratory or blood samples tested positive for novel coronavirus, 3. A novel coronavirus nucleic acid was detected in respiratory or anal swabs after 10 days of standard treatment with roranavir / ritonavir, 4. Willing to take contraception during the study and within 7 days after treatment, 5. No difficulty in swallowing the Pills, 6. Willing to sign informed consent form.

1. Any situation which the protocol cannot be carried out safely, 2. Patient refuses to receive invasive tracheal support (if needed), 3. Pregnant or lactating women:childbearing age women with positive pregnancy test, breastfeeding, miscarriage or within 2 weeks after delivery.Postmenopausal and hysterectomy women do not need a pregnancy test, 4. Patients with chronic liver and kidney disease and reaching end-stage, 5. Previous history of allergic reactions to Fapiravir or Lopinavir and Ritonavir, 6. After the investigator's judgment, the subjects could not participate the study protocol, follow-up or self-evaluation after enrollment.

2

The Third People's Hospital of Shenzhen

16

75

China

No restriction on type of patients

0: No restriction on type of patients

30

Blood routine tests; Liver function examination; Renal function examination; Blood gas analysis; Chest CT examination;

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

Phase 0

[{"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1123, "treatment_name": "Ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]