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 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT04356833
Eligibility Criteria:
Inclusion Criteria (cohorts 1 and 2):
1. Patients with COVID-19 (confirmed by PCR or radiologically)
2. ≥16 years
3. Willing and able to provide written informed consent or where patient doesn't have capacity, consent obtained from a legal representative
4. Patients on IMV must meet both the following criteria:
1. PaO2/FiO2 of ≤ 300 (definition of ARDS)
2. Intubated \> 6 hrs
5. Patients not intubated must meet the following criteria:
1. PaO2/FiO2 ≤ 300 or equivalent imputed by non-linear calculation from SpO2/FiO2 (see look-up table in appendices)
2. In-patient \>6 hours and being actively treated
3. On support with non-invasive ventilation OR continuous positive airway pressure (CPAP) OR high flow OR standard oxygen therapy
Exclusion Criteria (cohort 1):
1. Females who are pregnant
2. Concurrent involvement in another experimental investigational medicinal product
3. Known allergies to the IMP or excipients of IMP
4. A pre-existing bleeding disorder (e.g. severe haemophilia) with no definitive treatment
5. Pre-existing severe cardiopulmonary disease (e.g. incurable lung cancer, severe chronic obstructive lung disease, cardiomyopathy, heart failure or impaired contractility \<estimated 40% LVEF or RVEF)
6. Fibrinogen \< 2.0 g/L at time of screening
7. Patients considered inappropriate for active treatment (e.g. being considered for palliative care)
8. Patients with active bleeding in the preceding 7 days
9. Patients who in the opinion of the investigator are not suitable
Exclusion Criteria (cohort 2):
1. Females who are pregnant
2. Known allergies to the IMP or excipients of IMP
3. Fibrinogen \< 1.5 g/L at time of screening
4. Patients considered inappropriate for active treatment (e.g. being considered for palliative care)
5. Patients who in the opinion of the investigator are not suitable
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT04356833
Study Brief:
Protocol Section:
NCT04356833