COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001391-15/IE

Royal College of Surgeons Ireland - Mandy Jackson

mandyjackson@Rcsi.ie

2020-03-31

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1.Laboratory confirmed diagnosis of COVID-19 infection 2. Moderate to severe ARDS with a PaO2/FiO2 ratio <200 3. >18 years of age 4. Patients receiving invasive mechanical ventilation or non-invasive ventilation

1. Not receiving invasive mechanical ventilation or non invasive ventilation 2. More than 96 hours from the onset of ARDS 3. Age < 18 years 4. Known to be pregnant or breastfeeding 5. Participation in a clinical trial of interferon therapies, immune plasma therapies or immunoglobulin within 30 days 6. Major trauma in the prior 5 days 7. Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last year 8. WHO Class III or IV pulmonary hypertension 9. Pulmonary embolism within past 3 months 10. Currently receiving extracorporeal life support (ECLS) 11. Currently receiving renal replacement therapy 12. Severe chronic liver disease with Child-Pugh score > 12 13. DNAR (Do Not Attempt Resuscitation) order in place 14. Treatment withdrawal imminent within 24 hours 15. Prisoners 16. Non-English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available. 17. Enrolled in a concomitant clinical trial of interferon therapies, immune plasma therapies or immunoglobulin. 18. IgA deficiency

3

Royal College of Surgeons Ireland

18

None

Ireland

Severe disease at enrollment

6: Severe disease at enrollment

36

The primary effectiveness outcome measure, a continuous variable, is IL-6 in plasma as measured by ELISA.

Declared number of arm (4.0) differs from found arms (2.0)

Phase 2

[{"arm_notes": "Once", "treatment_id": 589, "treatment_name": "Human alpha-1-proteinase inhibitor", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "Weekly", "treatment_id": 589, "treatment_name": "Human alpha-1-proteinase inhibitor", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]