An exploratory Phase II investigator-initiated clinical trial of the efficacy and safety of TM5614 in patients with novel coronavirus pneumonia

JRCT ID: jRCT2021200018

Registered date:18/08/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: novel coronavirus (SARS-CoV-2) pneumonia
• Date of first enrollment: 07/10/2020
• Target sample size: 30
• Study type: Interventional
• Intervention(s): TM5614 is started at 120 mg once daily for a 14-day period. On Day 7, it will be confirmed whether the drug could be increased and in case determined that the dose could be increased, the dose will be increased to 180 mg from the next day. However, if bleeding symptoms, liver dysfunction are seen on Day 7, or if it is considered impossible to increase the dose to 180 mg, the dose will be continued at 120 mg.

Outcome(s)

• Primary Outcome: Existence of deterioration of oxygenation requiring ventilator management

Secondary Outcome

1. Survival for 28 days from the start of study drug administration
2. Duration of hospitalization after starting study drug administration
3. Number of days required for oxygen administration after starting study drug administration
4. P/F ratio (PaO2/FiO2)
5. Changes in the proportion of lung field lesions on chest CT images before and after study drug administration

Key inclusion & exclusion criteria

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

Include criteria

(1) Inpatients over the age of 20 obtained by written consent
(2) Patients who are positive for COVID-19 by RT-PCR test or antigen test
(3) Patients with a finding consistent with novel coronavirus pneumonia on chest CT examination
(4) Patients with room air SpO2 <95% at rest
(5) Patients who require less than 5 L/min oxygen concentration
(6) Patients who are not on a ventilator
(7) Patients whose AST or ALT value is 2.5 times or less than the institutional upper limit
(8) Patients whose total bilirubin level is 2.5 times or less than the institutional upper limit
(9) Patients with creatinine clearance (calculated by Cockcroft-Gault formula) of 30 mL/min or more

Exclude criteria

(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
(8) Patients on anticoagulants and other concomitantly prohibited drugs that are difficult to discontinue
(9) Patients judged by the investigator or co-investigator to be inappropriate for other reasons

Related Information

• Primary Sponsor: Harigae Hideo
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development