Predicting Deterioration of COVID-19 using Biomarkers

UMIN ID: UMIN000045462

Registered date:15/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 2021/09/20
• Target sample size: 70
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Newly initiated oxygen therapy by 14 days after admission
• Secondary Outcome: National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale and Japanese Ministry of Health, Labor, and Welfare severity classification of COVID-19 on Day 0,2,4,6,8,10,12,14, as well as on the day when oxygen therapy is initiated and the day when mechanical ventilation is initiated. In-hospital, 28-day, and 90-day mortality. Hospital-, ICU-, oxygen-, ventilator-, RRT-, and vasopressor-free days until Day 28 after admission. Tracheostomy and time when tracheostomy is performed. Organ failure score such as Sequential Organ Failure Assessment score (SOFA score) and Japanese Association for Acute Medicine disseminated intravascular coagulation criteria (JAAM DIC diagnostic criteria) on Day 0, 2, 7, 14 after admission.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) hepatitis C 2) Rheumatoid arthritis and autoimmune diseases 3) Immunosuppressed patients 4) Patient who is expected to die within 48 hours after admission 5) Patient who is considered to be inappropriate for the inclusion to this study by a treating physician

Related Information

• Primary Sponsor: Keio University
• Source(s) of Monetary Support: Sysmex Corporation