A Randomized Open label Phase-II Clinical Trial with or without Infusion of Plasma from Subjects after Convalescence of SARS-CoV-2 Infection in High-Risk Patients with Confirmed Severe SARS-CoV-2 Disease

Phase 1

• Conditions: Coronavirus disease 2019 (COVID-19) / SARS-CoV-2 Disease; MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; MedDRA version: 23.1Level: PTClassification code 10084460Term: COVID-19 treatmentSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 23.0Level: LLTClassification code 10084270Term: SARS-CoV-2 acute respiratory diseaseSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]; MedDRA version: 23.1Level: LLTClassification code 10084439Term: SARS-CoV-2 serology test positiveSystem Organ Class: 100000004848; MedDRA version: 21.1Level: LLTClassification code 10054540Term: Passive immunizationSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2020-001632-10-DE
• Lead Sponsor: Ruprecht-Karls-Universität Heidelberg, Medical Faculty, University Hospital Heidelberg -

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-20
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

1. PCR confirmed SARS-CoV-2 infection in a respiratory tract sample.

2. Oxygen saturation (SaO2) of 94 % or less while breathing ambient air or a ratio of the
partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) of less than 300 mm Hg.

3. High risk due to either pre-existing or concurrent hematological malignancy and/or active cancer therapy (incl. chemotherapy, radiotherapy, surgery) within the last 24 months or less (group 1)

and/or
chronic immunosuppression not meeting the criteria of group 1 (group 2)

and/or
Age = 50 - 75 years meeting neither the criteria of group 1 nor group 2 (group 3)
and at least one of these criteria: Lymphopenia < 0.8 x G/l
and/or
D-dimer > 1µg/mL

and/or
Age = 75 years meeting neither the criteria of group 1 nor group 2 (group 4).

4. Blood hemoglobin concentration = 8 g/dl.

5. Provision of written informed consent.

6. Patient is able to understand and comply with the protocol for the duration of the study, including treatment and scheduled visits and examinations.

7. Male or female patient aged = 18 years.

8. Postmenopausal or evidence of non-childbearing status. For women of childbearing potential: negative urine or serum pregnancy test within 14 days prior to study treatment.
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 87
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 87

Exclusion Criteria

1. Dementia, psychiatric or cognitive illness or recreational drug/alcohol use that in the
opinion of the principle investigator, would affect subject safety and/or compliance.

2. Contraindication to transfusion or history of prior reactions to transfusion blood
products.

3. Patients with known selective IgA deficiency.

4. Patients with mechanical ventilation and/or extracoporal membrane oxygenation
(ECMO) at time of initial inclusion into the trial.

5. Participation in another trial with an investigational medicinal product.

6. Treatment with SARS-CoV-2 convalescent plasma in the past.

Study & Design

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