A randomized, double blinded clinical trial of convalescent plasma compared to standard plasma for treatment of hospitalized non-IC patients with COVID-19 infections
- Conditions
- COVID-1910047438
- Registration Number
- NL-OMON49946
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 430
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
swap)
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
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
8. Liver failure: Bilirubin > 5xULN and elevation of ALT /AST (at least one
>10xULN).
9. Any history of severe adverse reactions to plasma proteins
10. Known deficiency of immunoglobulin A
11. Pregnancy
12. Breastfeeding women
13. Volume overload until sufficiently treated
14. Pulmonary edema
15. Participation in another clinical trial for treatment of COVID-19
16. Psychiatric or cognitive illness or recreational drug/alcohol use that in
the opinion of the principal investigator, would affect subject safety and/or
compliance
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method