COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04425733

Medical Director Merck Sharp & Dohme Corp.

Not reported

2020-06-11

Withdrawn

RCT

Randomized

Sequential assignment

Blind label

unclear

Treatment

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)

- 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

2

Merck Sharp & Dohme LLC

18

80

None

Moderate disease at enrollment

3: Moderate disease at enrollment

0

Number of Participants Who Experience an Adverse Event (AE);Change From Baseline to Day 7 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2);Change From Baseline to Day 4 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2);Number of Participants Who Discontinued Study Drug Due to an Adverse Event (AE);Change From Baseline to Day 6 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2);Change From Baseline to Day 1 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2);Change From Baseline to Day 3 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2);Change From Baseline to Day 5 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2);Change From Baseline to Day 2 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)

None

Phase 1

[{"arm_notes": "", "treatment_id": 806, "treatment_name": "Mk-5475", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]