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
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