The study assesses the efficacy of early administration of hyperimmune plasma in covid-19 patients who are on CPAP or intubated. Efficacy is measured as a 2 point decrease in the WHO scale
Patients who satisfy eligibility criteria and in particular have started positive pressure
respiratory support not more than no more than 48 hours are administered 200 to 300 ml in 2
or 3 times administered over a time window of 5 days. . Plasma titration will depend on the
availability in the local Plasma Bank; any titre ≥ 1:80 will be acceptable. primary endpoint
will be assessed at 28 days; vital status will be further investigated at 3 and 6 months.
Other: hyperimmune plasma
plasma collected from convalescent Covid-19 donors with titre 1:80 or more
Inclusion Criteria:
1. 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.
2. Male or female adult patient ≥18 years of age at time of enrolment.
3. Laboratory-confirmed SARS-CoV-2 infection as determined by real-time RT-PCR in
naso/oropharyngeal swabs or any other relevant specimen..
4. Patient is hospitalized for COVID-19, is severely hypoxic with a P/F ≤ 200 while
breathing room air or supplemental oxygen and requires positive pressure respiratory
support, either non-invasive (helmet/mask CPAP or NIV) or invasive (endotracheal
intubation and mechanical ventilation)
5. No more than 48 hours between the onset of positive pressure respiratory support and
treatment administration day
6. Evidence of pulmonary infiltrates at chest imaging (chest x-ray, CT scan or LUS)
7. The patient is not eligible in the Tsunami trial.
Exclusion Criteria:
1. Participation in any other clinical trial of an experimental treatment for COVID-19.
2. In the opinion of the clinical team, progression to death is imminent and inevitable
within the next 24 hours, irrespective of the provision of treatments.
3. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30).
4. Pregnancy
5. Current documented and uncontrolled bacterial infection.
Catherine Klersy
Pavia, Italy
Francesco Mojoli, MD, Principal Investigator
Fondazione IRCCS Policlinico San Matteo