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A randomized, open-label, controlled trial for the efficacy and safety of Farpiravir Tablets in the treatment of patients with novel coronavirus pneumonia (COVID-19)

A randomized, open-label, controlled trial for the efficacy and safety of Farpiravir Tablets in the treatment of patients with novel coronavirus pneumonia (COVID-19)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029996
Enrollment
Unknown
Registered
2020-02-20
Start date
2020-02-20
Completion date
Unknown
Last updated
2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Low-dose group:Tablets
The adult dose is 1600 mg per time on first day
the duration of treatment will be 10 d.
Middle-dose group:Tablets
The adult dose is 1800 mg per time on first day
High-dose group:Tablets
The adult dose is 2400 mg per time on first day

Sponsors

Beijing Chaoyang Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign the Consent Form; 2. Male or female aged 18 and over; 3. According to the "Diagnosis and Treatment Scheme for Pneumonia of Novel coronavirus pneumonia Infection-Trial Fifth Edition", inpatient diagnosed with Novel coronavirus pneumonia diagnosed and clinical classification of ordinary type: Inpatients with fever (underarm temperature >= 37.0 degree C), respiratory tract, etc. Imaging shows pneumonia.

Exclusion criteria

Exclusion criteria: 1. Females who are pregnant or likely to be pregnant, or who are lactating and unable to stop breastfeeding, or who have positive pregnancy tests during screening; 2. Males or females who have a birth plan or are unwilling to take reliable contraceptive measures for contraception within 90 days from signing the informed consent to the last dose; 3. Other circumstances that the researchers consider inappropriate for participation in this study.

Design outcomes

Primary

MeasureTime frame
Time to Clinical Recovery;

Secondary

MeasureTime frame
The incidence of common Novel coronavirus pneumonia progressing to severe;Release and quarantine time;Time when common Novel coronavirus pneumonia progress to severe;Proportion to ICU;Mechanical ventilation rate;mortality rate;Time for the main clinical manifestations to subside (fever, dry cough, fatigue);Duration of fever;Changes in viral load over time;Time for the virus to turn negative;

Countries

China

Contacts

Public ContactZhaohui Tong

Beijing Chaoyang Hospital, Capital Medical University

13910930309@163.com+86 13910930309

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026