COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49013

Qiu Yunqing

qiuyq@zju.edu.cn

2020-02-03

Not recruiting

RCT

Randomized

Parallel

Not reported

single-center

Treatment

1. 18 to 75 years of age, male or female, willing to sign 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. At least 2 viral nucleic acid tests are still positive under current antiviral therapy, 4. No difficulty in swallowing the pills, 5. Willing to abide by the protocol.

1. Allergic constitution, known to be allergic to balosavir or farpiravir or pharmaceutical excipients, 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. In the investigator's judgment, there are other factors that may cause the subject to be forced to terminate the study, such as other serious illnesses, serious laboratory abnormalities, and other factors that may affect the safety of the subject or the collection of test data and blood samples.

3

The First Hospital Affiliated to Zhejiang University's Medical School

18

75

China

Mild disease at enrollment

1: Mild disease at enrollment

30

Time to viral negativity by RT-PCR;Time to clinical improvement;

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 0

[{"arm_notes": "Study published results but recruitment status on registry is always not yet recruiting", "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": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]