A Clinical Trial of Convalescent Plasma Compared to Best Supportive Care for Treatment of Patients With Severe COVID-19

• Status: Completed
• Trial end date: 2021-02-22
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, prospective, multicenter, open label clinical trial of convalescent plasma compared to best supportive care for treatment of patients with severe COVID-19.

The aim of the study is to explore the therapeutic effect of convalescent plasma transfusions on the survival and course of disease of patients with severe COVID-19. Convalescent plasma will be collected from recovered COVID-19 patients.

Patients with severe COVID-19 will be randomly assigned to two groups. Patients in the treatment group will receive covalescent plasma (250 - 325 ml) on days 1, 3 and 5. Patients in the control group will receive best supportive care. Clinical condition in all patients will be evaluated on day 14. In case of progressive COVID-19 on day 14 compared to baseline, patients in the control group may be switched to treatment with convalescent plasma on days 15, 17 and 19.

Fifty-three patients will be included in each group. Data of each patient will be collected until discharge but nor longer than day 60.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen

Criteria

Inclusion Criteria:

Patients with SARS-CoV-2 infection and

1. age ≥ 18 years and ≤ 75 years

2. SARS-CoV-2 infection confirmed by PCR (BAL, sputum, nasal and/or pharyngeal swap)

3. severe disease defined by at least one of the following:

1. respiratory rate ≥ 30 breaths / minute under ambient air

2. requirement of any type of ventilation support

3. needs ICU treatment

4. Written informed consent by patient or legally authorized representative

Exclusion Criteria:

1. Accompanying diseases other than COVID-19 with an expected survival time of less than 12 months.

2. Previous treatment with any SARS-CoV-2-convalescent plasma

3. In the opinion of the clinical team, progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatment

4. Interval > 72 hours since start of ventilation support

5. Not considered eligible for extracorporeal oxygenation support (even in case of severe ARDS according to Berlin classification with Horovitz-Index < 100 mg Hg)

6. Chronic obstructive lung disease (COPD), stage 4

7. Lung fibrosis with UIP pattern in CT und severe emphysema

8. Chronic heart failure NYHA >= 3 and/or pre-existing reduction of left ventricular ejection fraction to ≤ 30%

9. Shock of any type requiring ≥ 0.5 µg/kg/min noradrenaline (or equivalent) or requiring more than two types of vasopressor medication for more than 8 hours

10. Liver cirrhosis Child C

11. Liver failure: Bilirubin > 5xULN and elevation of ALT /AST (at least one >10xULN).

12. Any history of adverse reactions to plasma proteins

13. Known deficiency of immunoglobulin A

14. Pregnancy

15. Breastfeeding women

16. Volume overload until sufficiently treated

17. Participation in another clinical trial with an investigational medicinal product