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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT04462757
Eligibility Criteria:
Inclusion Criteria:
* Patient age 18 or above.
* Clinically suspected/proven COVID-19.
* Requiring organ support with one or more of:
* Non-invasive or invasive ventilatory support
* Receiving infusion of vasopressor or inotropes or both.
* No concomitant health problems that, in the opinion of the PI or designee in agreement with the treating clinician, would interfere with participation, administration of study drug or assessment of outcomes including safety.
Exclusion Criteria:
* More than 24h has elapsed since CCU admission.
* Death is deemed to be imminent and inevitable during the next 24h.
* One or more of: the patient, substitute decision-maker or the attending physician are not committed to full active treatment.
* Known condition resulting in ongoing immunosuppression including neutropenia (count \< 1.5 x 10\^9/L) prior to hospitalisation, malignancy, latent tuberculosis or chronic liver disease (if known).
* Previous or current treatment with anakinra or medication suspected of interacting with anakinra, listed in the drug SmPC, known at the time of trial entry or previous participation in this trial.
* Known to have received active treatment in a clinical trial of an investigational immunomodulatory agent (not including corticosteroids) within 30 days prior to study entry.
* Known to be pregnant or breast feeding or inability to reliably confirm that the patient is not pregnant.
* Known allergy to anakinra or any of the excipients listed in the drug SmPC
* Known allergy to other products that are produced by DNA technology using the micro-organism E. coli (e.g. Escherichia coli derived protein).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04462757
Study Brief:
Protocol Section:
NCT04462757