Participants |
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Inclusion criteria
Written informed consent prior to performing study procedures. Witnessed oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible
Male or female adult patient ≥ 18 years of age at time of enrolment
Laboratory‐confirmed SARS‐CoV‐2 infection as determined by PCR in naso/oropharyngeal swabs or any other relevant specimen
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Patients requiring hospitalisation for COVID‐19 without mechanical ventilation (invasive or non‐invasive) or high‐flow oxygen devices and at least 1 of the following:
radiographic evidence of pulmonary infiltrates by imaging (chest X‐ray, CT scan, etc.), or
clinical assessment (evidence of rales/crackles on exam) and SpO2 ≤ 94% on room air that requires supplemental oxygen
Not > 12 days between the onset of symptoms (fever or cough) and treatment administration day
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Exclusion criteria
Requiring mechanical ventilation (invasive or non‐invasive) or high‐flow oxygen devices
> 12 days since symptoms (fever or cough)
Participation in any other clinical trial of an experimental treatment for COVID‐19
In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 h, irrespective of the provision of treatments
Any incompatibility or allergy to the administration of human plasma
Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated GFR < 30)
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Outcomes |
Primary study outcome: category changes in ordinal scale (time frame: 15 days) (for categories: see additional outcomes)
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Primary review outcomes
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Secondary review outcomes
Number of participants with grade 3 and grade 4 AEs, including potential relationship between intervention and adverse reaction (e.g. TRALI, transfusion‐transmitted infection, TACO, TAD, acute transfusion reactions): yes
Number of participants with SAEs: yes
Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: yes
30‐day and 90‐day mortality: NR (up to 29 days)
Admission on the ICU: NR
Length of stay on the ICU: NR
Time to discharge from hospital: NR
QoL: NR
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Additional review outcomes
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Category changes in ordinal scale (time frame: 15 days)
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Time to category 5, 6 or 7 of the ordinal scale (time frame: 29 days)
Oxygenation‐free days (time frame: 29 days)
Ventilator‐free days
Change in biological parameters (time frame: days 1, 3, 5, 8, 11 and 29) ‐ serum levels of CRP, lymphocyte count, LDH, D Dimer, IL‐6, coagulation tests at baseline and days 3, 5, 8, 11, 15 and 29
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Antibodies levels in CP donors recovered from COVID‐19 (time frame: 3 months)
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Viral load (time frame: days 1, 3, 5, 8, 11 and 29)
change in PCR for SARS‐CoV‐2 in naso/oropharyngeal swabs and blood at baseline and on days 3, 5, 8, 11 (while hospitalised); and days 15 and 29 (if able to return to clinic or still hospitalised)
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