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:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2025-12-24 @ 11:05 PM
NCT ID:
NCT04447469
Eligibility Criteria:
Key Inclusion Criteria:
* Subject (or legally authorized representative) is able and willing to provide informed consent, which includes compliance with study requirements and restrictions listed in the consent form. Consent must be performed per institutional regulations.
* Age of ≥ 18 years
* Positive SARS-CoV-2 (2019-nCoV) test within 14 days prior to randomization
* Hospitalized for SARS-CoV-2 (2019-nCoV)
* Bilateral pneumonia on chest x-ray or computed tomography
* Clinical laboratory results indicative of hyper-inflammation within 7 days prior to randomization
* Cohort 1: Receiving any form of non-invasive ventilation OR oxygenation to maintain SpO2 ≥ 92% and non-mechanically ventilated (examples include nasal cannula, face mask, venturi mask, high-flow nasal cannula, or non-invasive positive pressure ventilation)
* Cohort 2: Recently ventilated with mechanical ventilation beginning within 48 hours prior to randomization
Key Exclusion Criteria:
* Onset of COVID-19 symptoms \> 14 days prior to randomization
* Hospitalized \> 7 days prior to randomization
* Need for invasive mechanical ventilation (Only for Cohort 1)
* Need for ECMO
* Serious prior or concomitant illness that in the opinion of the Investigator precludes the subject from enrolling in the trial
* Recent treatment with cell-depleting biological therapies (eg, anti-CD20) within 12 months, non-cell-depleting biological therapies (such as anti-tumor necrosis factor \[TNF\], anakinra, anti-IL-6 receptor \[eg, tocilizumab\], or abatacept) within 8 weeks (or 5 half-lives, whichever is longer), treatment with alkylating agents within 12 weeks, treatment with cyclosporine A, azathioprine, cyclophosphamide, mycophenolate mofetil (MMF), or other immunosuppressant (except for corticosteroids) within 4 weeks prior to randomization. Medications that become standard of care for COVID-19 and/or receive emergency use authorization may be allowed after discussion with the medical monitor.
* If subject is receiving or has received hydroxychloroquine within 3 months prior to screening visit, a corrected QT interval by Federicia method (QTcF) on Screening electrocardiogram (ECG) ≥500ms is exclusionary. If subject has a pacemaker, this criterion does not apply.
* Enrolled in another investigational study of a medical intervention within 30 days prior to randomization. Participation in open label trials involving investigational treatments for COVID-19 may be allowed upon approval by the Sponsor.
* Life expectancy less than 48 hours, in the opinion of the Investigator
* Known human immunodeficiency virus infection (regardless of immunological status), known hepatitis B virus surface antigen positivity and/or anti-hepatitis C virus positivity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04447469
Study Brief:
Protocol Section:
NCT04447469