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 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
NCT ID:
NCT05639192
Eligibility Criteria:
Inclusion Criteria:
* Patient must be willing and able to give informed consent to participate in the trial and to adhere to the procedures stated in the protocol
* ≥18 years of age
* Patient is admitted to a hospital (max. 72 hours prior to randomization) due to COVID-19 and has a positive SARS-CoV-2 PCR test
* Clinical symptoms indicative of moderate or severe illness (corresponding to score 5 or 6 on the WHO 10-point clinical progression scale) with COVID 19 prior to trial treatment
* Patient agrees to not participate in another clinical trial from screening until day 56
Exclusion Criteria:
* Patient is moribund or has an estimated life expectancy \<1 month (e.g., terminal cancer, etc.)
* Patient is anticipated to be discharged from hospital within 48 hours
* Patient requires anti-inflammatory medicines beyond SoC (SoC are drugs that are approved for treatment of COVID-19 as well as medicines that have been recommended in treatment guidelines of national health authorities and/or professional organization)
* Patient requires invasive mechanical ventilation
* Patient is known to have active tuberculosis
* Patient is known to have hereditary fructose intolerance.
* Patient is known to have co-infection with Influenza viruses or other viral respiratory infections (respiratory syncytial virus \[RSV\], parainfluenza viruses, respiratory adenoviruses).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05639192
Study Brief:
Protocol Section:
NCT05639192