Status:
COMPLETED
A Clinical Trial of Convalescent Plasma Compared to Best Supportive Care for Treatment of Patients With Severe COVID-19
Lead Sponsor:
Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen
Conditions:
COVID-19
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
This is a randomized, prospective, multicentre, open label clinical trial of convalescent plasma compared to best supportive care for treatment of patients with severe COVID-19. The primary Endpoint ...
Eligibility Criteria
Inclusion
- Patients with SARS-CoV-2 infection and
- age ≥ 18 years and ≤ 75 years
- SARS-CoV-2 infection confirmed by PCR (BAL, sputum, nasal and/or pharyngeal swap)
- severe disease defined by at least one of the following:
- respiratory rate ≥ 30 breaths / minute under ambient air
- requirement of any type of ventilation support
- needs ICU treatment
- Written informed consent by patient or legally authorized representative
Exclusion
- Accompanying diseases other than COVID-19 with an expected survival time of less than 12 months.
- Previous treatment with any SARS-CoV-2-convalescent plasma
- 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
- Interval \> 72 hours since start of ventilation support
- Not considered eligible for extracorporeal oxygenation support (even in case of severe ARDS according to Berlin classification with Horovitz-Index \< 100 mg Hg)
- Chronic obstructive lung disease (COPD), stage 4
- Lung fibrosis with UIP pattern in CT und severe emphysema
- Chronic heart failure NYHA \>= 3 and/or pre-existing reduction of left ventricular ejection fraction to ≤ 30%
- 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
- Liver cirrhosis Child C
- Liver failure: Bilirubin \> 5xULN and elevation of ALT /AST (at least one \>10xULN).
- Any history of adverse reactions to plasma proteins
- Known deficiency of immunoglobulin A
- Pregnancy
- Breastfeeding women
- Volume overload until sufficiently treated
- Participation in another clinical trial with an investigational medicinal product
Key Trial Info
Start Date :
August 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2022
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04433910
Start Date
August 30 2020
End Date
March 25 2022
Last Update
September 14 2023
Active Locations (16)
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1
University Hospital Ulm
Ulm, Baden-Württmberg, Germany, 89081
2
University Hopsital Frankfurt
Frankfurt, Hessia, Germany, 60590
3
Saarland University Hospital
Homburg, Saarland, Germany, 66421
4
University Hospital Berlin, Charite
Berlin, Germany, 13353