COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49015

Yunqing Qiu

qiuyq@zju.edu.cn

2020-02-04

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. Aged 18 to 75 years male or female, willing to sign the informed consent, 2. Tested positive for novel coronavirus infection after the onset of symptoms using a real time polymerase chain reaction (RT-PCR)-based diagnostic assay, 3. Enrollment and initiation of study drug treatment <=96 hours after onset of symptoms, 4. No difficulty in swallowing the pills, 5. Willing to abide by the protocol.

1. Hypersensitive to study drug, 2. Body weight <40 kg, 3. Considered as severe disease: has an ongoing respiratory deficiency and subjected to invasive mechanical ventilation, or presence of shock, or admitted to the ICU due to complications, 4. Has known kidney dysfunction determined as CLcr<60 mL/min, 5. Increase in alanine aminotransferase (ALT) / aspartate aminotransferase (AST) is more than 5 times the upper limit of normal, or increase in ALT or AST is more than 3 ULN and increase in total bilirubin more than 2 ULN, 6. Pregnancy or breastfeeding,or positive pregnancy test in a predose examination, or have a plan to be pregnant within 3 months after the study.

3

The First Affiliated Hospital; Zhejiang University School of Medicine

18

75

China

Mild disease at enrollment

1: Mild disease at enrollment

30

Time to viral negativityby RT-PCR;Time to clinical improvement: Time from start of study drug to hospital discharge or to NEWS2<2 for 24 hours.;

| Declared number of arm (4.0) differs from found arms (5.0)

Phase 0

[{"arm_notes": "", "treatment_id": 178, "treatment_name": "Baloxavir marboxil", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]