Frespaciguat (MK-5475) in Participants With Hypoxemia Due to COVID-19 Pneumonia (MK-5475-009)
NCT ID: NCT04425733
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2020-07-07
2020-11-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Panel A Frespaciguat 180 µg
Participants receive 180 µg of frespaciguat once daily (QD) via inhalation from Days 1-7.
Frespaciguat
Frespaciguat administered at a dose of 180 µg or ≤360 µg QD via inhalation
Panel A Placebo
Participants receive frespaciguat-matching placebo QD via inhalation from Days 1-7.
Placebo
Frespaciguat-matching placebo administered QD via inhalation
Panel B Frespaciguat 360 µg
Participants receive 360 µg of frespaciguat QD via inhalation from Days 1-7.
Frespaciguat
Frespaciguat administered at a dose of 180 µg or ≤360 µg QD via inhalation
Panel B Placebo
Participants receive frespaciguat-matching placebo QD via inhalation from Days 1-7.
Placebo
Frespaciguat-matching placebo administered QD via inhalation
Panel C Frespaciguat ≤360 µg
Participants receive ≤360 µg of frespaciguat QD via inhalation from Days 1-7.
Frespaciguat
Frespaciguat administered at a dose of 180 µg or ≤360 µg QD via inhalation
Panel C Placebo
Participants receive frespaciguat-matching placebo QD via inhalation from Days 1-7.
Placebo
Frespaciguat-matching placebo administered QD via inhalation
Interventions
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Frespaciguat
Frespaciguat administered at a dose of 180 µg or ≤360 µg QD via inhalation
Placebo
Frespaciguat-matching placebo administered QD via inhalation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Other Identifiers
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MK-5475-009
Identifier Type: OTHER
Identifier Source: secondary_id
2020-002062-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
5475-009
Identifier Type: -
Identifier Source: org_study_id
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