COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04261907

Not reported

Not reported

2020-02-10

Terminated

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: - 1. aged between 18 and 75 years, extremes included, male or female - 2. laboratory (rt-pcr) and clinical symptoms confirmed case of 2019-ncov pneumonia, according to the official guideline "pneumonia diagnosis and treatment scheme for novel coronavirus infection (trial version 5)" - 3. hospitalised with a new onset respiratory illness (≤7 days since illness onset) - 4. no family planning within six months, and agree to take effective contraceptive measures throughout the study and for at least 30 days after the final study drug dose - 5. must agree not to enroll in another study of an investigational agent prior to completion of day 30 of study - 6. informed consent form (icf) signed voluntarily

- 1. severe 2019-ncov pneumonia met one of the following criteria: respiratory distress, rr ≥ 30 times / min, or sao2 / spo2 ≤ 93% in resting state, or arterial partial pressure of oxygen (pao2) /concentration of oxygen (fio2) ≤ 300mmhg (1mmhg = 0.133kpa) - 2. critical severe 2019-ncov pneumonia met one of the following criteria: respiratory failure and mechanical ventilation required, or shock, or combined with other organ failure required icu monitoring treatment - 3. severe liver disease (e.g. child pugh score ≥ c, ast > 5 times upper limit) - 4. known allergic reaction to any of components of asc09 / ritonavir compound tablets - 5. patients with definite contraindications in the label of ritonavir - 6. positive serum pregnancy test result for women with childbearing potential at screening - 7. using hiv protease inhibitor drugs - 8. not suitable for the study, in the opinion of the investigator (e.g. patient may be transferred to another hospital during the study period, patient with multiple basic diseases, etc.)

2

First Affiliated Hospital of Zhejiang University

18

75

China

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

6

The incidence of composite adverse outcome

None

Not reported

[{"arm_notes": "", "treatment_id": 1414, "treatment_name": "Asc09+ritonavir", "treatment_type": "Anti-inflammatories+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]