COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04462757

Rachel Cox

Not reported

2020-07-08

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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.

- 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).

2

University of Manchester

18

100

United Kingdom

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

5

Plasma IL-6 levels;Plasma IL-1Ra levels

None

Phase 2

[{"arm_notes": "", "treatment_id": 83, "treatment_name": "Anakinra", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 83, "treatment_name": "Anakinra", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}]