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Clinical Trials/EUCTR2020-001310-38-DE
EUCTR2020-001310-38-DEActive, not recruitingPhase 1

A randomized, prospective, open label clinical trial on the use of convalescent plasma compared to best supportive care in patients with severe COVID-19 - Convalescent Plasma against COVID-19

DRK-Bluspendedienst Baden-Württemberg - Hessen gGmbH0 sites120 target enrollmentStarted: March 31, 2020Last updated:
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
120

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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
  • 3.severe disease defined by at least one of the following:
  • a.respiratory rate = 30 breaths / minute under ambient air
  • b.requirement of any type of ventilation support
  • c.needs ICU Treatment
  • 4. Written informed consent by patient or legally authorized representative
  • 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 88
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

  • 1.Accompanying diseases other than COVID-19 with an expected survival time of
  • less than 12 months
  • 2.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
  • 3.Interval > 72 hours since start of ventilation support
  • 4.Not considered eligible for extracorporeal oxygenation support (even in case of
  • severe ARDS according to Berlin classification with Horovitz-Index < 100 mg Hg)
  • 5.Chronic obstructive lung disease (COPD), stage 4
  • 6.Lung fibrosis with UIP pattern in CT and severe emphysema
  • 7.Chronic heart failure NYHA = 3 and/or pre-existing reduction of left ventricular
  • ejection fraction to = 30%
  • 8.Cardiovascular failure requiring = 0.5 µg/kg/min noradrenaline (or equivalent) or
  • requiring more than two types of vasopressor medication
  • 9.Liver cirrhosis Child C
  • 10.Liver failure: Bilirubin > 5 x ULN and elevation of ALT or AST (> 10 x ULN)
  • 11.Any history of adverse reactions to plasma proteins
  • 12.Known deficiency of immunoglobulin A
  • 13.Pregnancy
  • 14.Breastfeeding women
  • 15.Volume overload until sufficiently treated
  • 16.Pulmonary edema
  • 17.Participation in another clinical trial for treatment of COVID-19

Investigators

Sponsor
DRK-Bluspendedienst Baden-Württemberg - Hessen gGmbH

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