Status:
WITHDRAWN
Frespaciguat (MK-5475) in Participants With Hypoxemia Due to COVID-19 Pneumonia (MK-5475-009)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Coronavirus Disease 2019 (COVID-19)
Pneumonia
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate safety, tolerability, and pharmacodynamics of frespaciguat after administration of multiple doses to participants with COVID-19 pneumonia. The primary hypothes...
Eligibility Criteria
Inclusion
- Has virologically confirmed COVID-19 requiring hospital admission.
- Has respiratory symptoms including cough and dyspnea
- Requires supplemental oxygen therapy
- Male participant is abstinent from heterosexual intercourse or agrees to use contraception during the intervention period and for at least 14 days, corresponding to time needed to eliminate study intervention(s) (example, 5 terminal half-lives after the last dose of study intervention)
- Female participant is not a woman of childbearing potential (WOCBP) or is a WOCBP who is abstinent from heterosexual intercourse or using contraception during the intervention period and for at least 14 days, corresponding to time needed to eliminate study intervention(s) (example, 5 terminal half-lives after the last dose of study intervention)
Exclusion
- Has pre-existing medical conditions of any nature which are immediately pre-terminal such as death or limitation of life-sustaining therapy is expected to be imminent
- Requires or is expected to require invasive mechanical ventilation
- Requires or is expected to require noninvasive mechanical ventilation
- Has any issue which would prohibit them from effective use of the frespaciguat inhaler
- Hypoxemia which is explained by any condition other than COVID-19, example, preexisting cardiac or pulmonary disease
- Has severe hepatic impairment (meets Child-Pugh Class C criteria)
- Has severe renal impairment and/or requirement for renal dialysis
Key Trial Info
Start Date :
July 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04425733
Start Date
July 7 2020
End Date
November 10 2020
Last Update
May 15 2025
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