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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Withdrawn
Phase 1

Conditions

Coronavirus Disease 2019 (COVID-19)
Pneumonia
Hypoxemia

Treatments

Drug: Placebo
Drug: MK-5475

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 MK-5475 after administration of multiple doses to participants with COVID-19 pneumonia. The primary hypothesis is that MK-5475 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 MK-5475 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

0 participants in 6 patient groups, including a placebo group

Panel A MK-5475 180 µg
Experimental group
Description:
Participants receive 180 µg of MK-5475 once daily (QD) via inhalation from Days 1-7.
Treatment:
Drug: MK-5475
Panel A Placebo
Placebo Comparator group
Description:
Participants receive MK-5475-matching placebo QD via inhalation from Days 1-7.
Treatment:
Drug: Placebo
Panel B MK-5475 360 µg
Experimental group
Description:
Participants receive 360 µg of MK-5475 QD via inhalation from Days 1-7.
Treatment:
Drug: MK-5475
Panel B Placebo
Placebo Comparator group
Description:
Participants receive MK-5475-matching placebo QD via inhalation from Days 1-7.
Treatment:
Drug: Placebo
Panel C MK-5475 ≤360 µg
Experimental group
Description:
Participants receive ≤360 µg of MK-5475 QD via inhalation from Days 1-7.
Treatment:
Drug: MK-5475
Panel C Placebo
Placebo Comparator group
Description:
Participants receive MK-5475-matching placebo QD via inhalation from Days 1-7.
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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