EUCTR2020-001632-10-DE
Active, not recruiting
Phase 1
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 - RECOVER
Ruprecht-Karls-Universität Heidelberg, Medical Faculty, University Hospital Heidelberg -0 sites174 target enrollmentApril 20, 2020
ConditionsCoronavirus disease 2019 (COVID-19) / SARS-CoV-2 DiseaseMedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestationsMedDRA version: 23.1Level: PTClassification code 10084460Term: COVID-19 treatmentSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 23.0Level: LLTClassification code 10084270Term: SARS-CoV-2 acute respiratory diseaseSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 23.1Level: LLTClassification code 10084439Term: SARS-CoV-2 serology test positiveSystem Organ Class: 100000004848MedDRA version: 21.1Level: LLTClassification code 10054540Term: Passive immunizationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Virus Diseases [C02]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Coronavirus disease 2019 (COVID-19) / SARS-CoV-2 Disease
- Sponsor
- Ruprecht-Karls-Universität Heidelberg, Medical Faculty, University Hospital Heidelberg -
- Enrollment
- 174
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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\)
- •chronic immunosuppression not meeting the criteria of group 1 (group 2\)
- •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
- •D\-dimer \> 1µg/mL
- •Age \= 75 years meeting neither the criteria of group 1 nor group 2 (group 4\).
- •4\. Blood hemoglobin concentration \= 8 g/dl.
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
- •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.
Outcomes
Primary Outcomes
Not specified
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