COVID-19 trials registries data warehouse

http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=16635

IN-GYU BAE

ttezebae@gmail.com

2020-05-11

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. 18 years old or older2. Patients who have been confirmed of COVID-19 infection and has evidence for pneumoniaA. Confirmation of COVID-19 infection by RT-PCR of SARS-CoV-2 B. Definite diagnosis of new infiltration of the lungs by chest CT scan of chest radiographic inspection3. Patients who are within 72 hours of COVID-19 pneumonia confirmation 4. Patients with 3 (hospitalization, not requiring supplemental oxygen) or higher in seven-category ordinal scale of clinical status5. Patients who are eligible for diagnosis/evaluation to chest CT scan and related to it6. Patients should be able to understand the essence of the clinical trial and to submit a written consent document. For the patients who can understand the nature of the research but cannot sign the document, a relative can agree to the study.

1. Patients who have a record of HIV or AIDS 2. Female patients, either who are pregnant within 6 months before the investigation, who breast-fed babies within 3 months before the investigation, or who may get pregnant or breast-feed within 1 month after the investigation is over3. Patients at high risk of death within 3 days of randomized assignment, by the judge of the investigator4. Patients with liver cirrhosis whose Child-Puch score is B or C5. Patients who have liver disease abnormalities with ALT or AST &gt, 5 times ULN 6. Patients who can be in danger or who shows clinically-important other conditions which may interfere with the evaluation or completion of the test procedure, as the investigator’s opinion7. Patients who are not appropriate for the test, as the investigator’s opinion8. Patients who have hypersensitivity to the investigational drug

2

Gyeongsang National University Hospital

18

100

Democratic People's Republic of Korea

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

84

Proportion of patients with clinical improvement as defined by live discharge from hospital or a decline of 2 categories on the seven-category ordinal scale of clinical status

Phase 2

[{"arm_notes": "", "treatment_id": 854, "treatment_name": "Nafamostat mesilate", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]