NL-OMON49946
Not yet recruiting
Phase 3
A randomized, double blinded clinical trial of convalescent plasma compared to standard plasma for treatment of hospitalized non-IC patients with COVID-19 infections - COV-PLAS
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 430
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Maximal 3 days hospitalized patients at plasma infusion.
- •2\. Age \* 18 years and \* 85 years
- •3\. SARS\-CoV\-2 infection: confirmed by PCR (BAL, sputum, nasal and/or pharyngeal
- •4\. Symptoms not expected to lead to IC transfer within 6 hours of first plasma
- •administration
- •5\. Written informed consent including storing of specimen for future testing
Exclusion Criteria
- •1\. Accompanying diseases other than COVID\-19 with an expected survival time of
- •less than 12 months
- •2\. Chronic obstructive lung disease (COPD), stage 4
- •3\. Lung fibrosis with UIP pattern in CT und Severe emphysema
- •4\. Chronic heart failure NYHA \>\= 3 and/or pre\-existing reduction of left
- •ventricular ejection fraction to \* 30%
- •5\. Cardiovascular failure requiring diuretics
- •6\. Signs of severe coagulopathy : thrombocytopenia a/o prolongation of the
- •PT/INR, PTT a/o elevation of D\-dimer, a/o decreased fibrinogen level waardes ?
- •7\. Liver cirrhosis Child C
Outcomes
Primary Outcomes
Not specified
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