Frespaciguat (MK-5475) in Participants With Hypoxemia Due to COVID-19 Pneumonia (MK-5475-009)

Merck Sharp & Dohme (MSD)

Status and phase: Withdrawn; Phase 1

Conditions: Coronavirus Disease 2019 (COVID-19); Pneumonia; Hypoxemia

Treatments: Drug: Frespaciguat; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04425733

MK-5475-009 (Other Identifier)

5475-009

2020-002062-14 (EudraCT Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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0 participants in 6 patient groups, including a placebo group

Panel A Frespaciguat 180 µg

Experimental group

Description:

Participants receive 180 µg of frespaciguat once daily (QD) via inhalation from Days 1-7.

Treatment:

Drug: Frespaciguat

Panel A Placebo

Placebo Comparator group

Description:

Participants receive frespaciguat-matching placebo QD via inhalation from Days 1-7.

Treatment:

Drug: Placebo

Panel B Frespaciguat 360 µg

Experimental group

Description:

Participants receive 360 µg of frespaciguat QD via inhalation from Days 1-7.

Treatment:

Drug: Frespaciguat

Panel B Placebo

Placebo Comparator group

Description:

Participants receive frespaciguat-matching placebo QD via inhalation from Days 1-7.

Treatment:

Drug: Placebo

Panel C Frespaciguat ≤360 µg

Experimental group

Description:

Participants receive ≤360 µg of frespaciguat QD via inhalation from Days 1-7.

Treatment:

Drug: Frespaciguat

Panel C Placebo

Placebo Comparator group

Description:

Participants receive frespaciguat-matching placebo QD via inhalation from Days 1-7.

Treatment:

Drug: Placebo