Teprenone for preventing aggravation of COVID-19

JRCT ID: jRCTs061200002

Registered date:20/05/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 15/07/2020
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Teprenone 50mg p.o. 3 times a day after each meal for 10 days

Outcome(s)

• Primary Outcome: Intubation rate

Secondary Outcome

1. Mortality
2. Period until fever relief
3. Oxygen dose
4. Change in chest CT images
5. Blood test values and theire rate of change
6. Severity
7. Period until discharge or lifting quarantine restrictions
8. Period until symptom disappearance
9. Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. 20 years-old or older
2. Confirmed diagnosis of COVID-19 with PCR or antigen test
3. temperature >= 37.5 degree Celsius
4. All subjects are required to have signed an informed consent document indicating that they understood the purpose of and procedures required for the study and are willing to participate in the study

Exclude criteria

1. Teprenon use within 2 weeks of study treatment
2. Patient who needs ventilator or ECMO
3. Active infectious disease requiring systemic treatment except for stable NTM
4. During pregnancy, within 28 days of postparturition, or during lactation.
5. Unidentified patient

Related Information

• Primary Sponsor: ICHIHARA Eiki
• Source(s) of Monetary Support: Okayama University