Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT04425733
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04425733
Study Brief:
Protocol Section:
NCT04425733