COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2021210006

Clinical Trial Coordinating Office

tm5614covid@c-ctd.co.jp

2021-05-28

Recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

1. Inpatients 20 years or over obtained by written consent2. Patients who are positive for COVID-19 by PCR or other methods based on gene amplification or antigen testing 3. Patients with a finding consistent with novel coronavirus pneumonia on chest CT examination4. Patients with room air SpO2 <96% at rest5. Patients who require less than 5 L/min oxygen concentration6. Patients who are not on a ventilator7. Patients whose AST or ALT value is 2.5 times or less than the institutional upper limit8. Patients whose total bilirubin level is 2.5 times or less than the institutional upper limit9. Patients with creatinine clearance (calculated by Cockcroft-Gault formula) of 30 mL/min or more

1. Patients on home oxygen therapy.2. kidney disease patients undergoing dialysis treatment.3. Patients with a history or complications of malignant tumors(except for those with no recurrence or new onset for at least 5 years after treatment).4. Patients with cirrhosis(Child-Pugh score class B and C).5. Pregnant or lactating patients.6. Patients who have participated in or are currently participating in other clinical trials within 30 days prior to enrollment in this clinical trial.7. Patients with bleeding tendency(Intracranial bleeding, Gastrointestinal hemorrahage, Urinary tract bleeding, Retroperitoneal hemorrhage, Hemoptysis).8. Patients with a high risk of bleeding, including:Patients with a history of intracranial hemorrhage or a predisposition to hemorrhage such as intracranial tumor, arteriovenous malformation, or aneurysm.Patients with a history of cerebral infarction(within 3 months).Patients who have undergone intracranial or spinal surgery or injury(within 3 months).Patients with a history of gastrointestinal or urinary tract bleeding(within 21 days).Patients who have undergone major surgery(within 14 days).Patients with a platelet count of less than 100000/mm3 before administration of study drug.Patients with severe hypertension.9. Patients on anticoagulants and other concomitantly prohibited drugs that are difficult to discontinue.10. Patients judged by the investigator or co-investigator to be inappropriate for other reasons.

2

Harigae Hideo

20

100

Japan

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

100

Oxygenation Index Scale

Phase 2

[{"arm_notes": "", "treatment_id": 1001, "treatment_name": "Plasminogen activator inhibitor-1 (pai-1)", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]