Trials / Withdrawn
WithdrawnNCT04425733
Frespaciguat (MK-5475) in Participants With Hypoxemia Due to COVID-19 Pneumonia (MK-5475-009)
A Study to Assess the Safety, Tolerability, and Pharmacodynamics of Multiple Dose MK-5475 in Participants With Hypoxemia Due to COVID-19 Pneumonia
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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 hypothesis is that frespaciguat when administered to participants with COVID-19 pneumonia and hypoxemia improves arterial oxygenation as measured by the ratio of blood oxygen saturation to fraction of inspired oxygen (SpO2/FiO2 ratio) compared to placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Frespaciguat | Frespaciguat administered at a dose of 180 µg or ≤360 µg QD via inhalation |
| DRUG | Placebo | Frespaciguat-matching placebo administered QD via inhalation |
Timeline
- Start date
- 2020-07-07
- Primary completion
- 2020-11-10
- Completion
- 2020-11-10
- First posted
- 2020-06-11
- Last updated
- 2025-05-15
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04425733. Inclusion in this directory is not an endorsement.