Clinical Study to assess positive value of blood plasma from donors having built immunity against the new corona virus (SARS-CoV-2) transfused to patients suffering from SARS-CoV-2 infectio

Phase 1

• Conditions: Patients with SARS-CoV-2 infection and:1.age = 18 years and = 75 years2.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: a.respiratory rate = 30 breaths / minute under ambient air b.requirement of any type of ventilation support c.needs ICU treatment; MedDRA version: 20.1Level: LLTClassification code 10047475Term: Viral pneumonia, unspecifiedSystem Organ Class: 100000004862; MedDRA version: 23.0Level: LLTClassification code 10070267Term: SARS virus test positiveSystem Organ Class: 100000004848; MedDRA version: 20.0Level: LLTClassification code 10021433Term: ImmunizationSystem Organ Class: 100000004865; MedDRA version: 21.1Level: LLTClassification code 10054540Term: Passive immunizationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001310-38-DE
• Lead Sponsor: DRK-Bluspendedienst Baden-Württemberg - Hessen gGmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-31
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

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:
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

Study & Design

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