A randomized double-blind placebo-controlled, pilot trial of intravenous plasma-purified alpha-1 antitrypsin for severe COVID-19 illness.

Phase 1

• Conditions: acute respiratory distress sydnrome (ARDS) secondary to Covid-19; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-001391-15-IE
• Lead Sponsor: Royal College of Surgeons Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-31
• Last Update Posted: 19 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified