COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCTs031200026

Shu Okugawa

okugawa-tky@g.ecc.u-tokyo.ac.jp

2020-05-01

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1) Patients who have given written consent to participate in the study2) SARS-CoV-2 PCR positive3) Patients with pneumonia on chest image4) Patients with fever over 37.5 degrees5) Pregnancy test-negative

1) Patients with fever over 37.5 degrees for more than 10 days2) Patients having less than 93% of oxygen saturation (SpO2) in without the oxygen administration3) Patients having cardiac dysfunctions such as congestive heart failure, having severe liver dysfunction, and having renal dysfunction requiring dialysis4) Patients having history of gout or currently undergoing treatment of gout or hyperuricemia5) Patients having disorders of consciousness such as disorientation6) Patients who are pregnant or who may be pregnant7)Patients who are suspected to have an infection with a microorganism other than SARS-COV-2, causative organism of pneumonia.8) Patients with hyperkalemia or hyponatremia9) Patients who are considered inappropriate for inclusion in the study by the investigator

2

Shu Okugawa

20

74

Japan

Moderate disease at enrollment

3: Moderate disease at enrollment

45

Change in patient condition on a 10-point scale from baseline to day7

Phase 3

[{"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1514, "treatment_name": "Favipiravir+nafamostat mesilate", "treatment_type": "Antivirals+coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]