Status:
UNKNOWN
Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the Treatment of Novel Coronavirus Pneumonia
Lead Sponsor:
Beijing Chao Yang Hospital
Conditions:
Novel Coronavirus Pnuemonia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
This study is a multi-centered, three-armed, randomized, double-blinded, controlled study, namely, the oral trial drug favipiravir tablets plus chloroquine phosphatetablets tablets group (combined gro...
Eligibility Criteria
Inclusion
- Male and female, 18-75 years old
- Patients previously diagnosed with novel coronavirus pneumonia: the course of illness is no more than 14 days; if the course of the disease was more than 14 days, patient meets one of the following conditions can also be included in the group: (1) No apparent absorption or progression of chest radiograph was observed within 7 days; (2) respiratory symptoms (chest tightness, or cough, or breathing difficulties); (3) Test for viral nucleic acid positive within 3 days.
- informed consent should be signed by the participate or an authorized agent
- Agree to clinical samples collection
- Female or male subjects of childbearing age agree to take effective contraceptive measures within 3 months of the last oral medication to ensure that female or male partners of childbearing age do not become pregnant
Exclusion
- Severe vomiting or difficulty ingesting medication
- Woman who are pregnant or during lactation
- Patients received lopinavir/ridonavir, ribavirin, interferon and monoclonal antibody specific antiviral drugs three days before enrollment
- Cases of respiratory failure requiring mechanical ventilation
- Shock
- Combined with other organ failure and requires ICU care
- Clinical prognostic non-survival, palliative care, or in deep coma and no have response to supportive treatment within three hours of admission
Key Trial Info
Start Date :
March 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 25 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04319900
Start Date
March 5 2020
End Date
June 25 2020
Last Update
March 24 2020
Active Locations (1)
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1
Beijing Chaoyang hospital
Beijing, Beijing Municipality, China, 100020