Status:
UNKNOWN
Early Use of Hyperimmune Plasma in COVID-19
Lead Sponsor:
Catherine Klersy
Collaborating Sponsors:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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
Detailed Description
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 admini...
Eligibility Criteria
Inclusion
- 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 real-time RT-PCR in naso/oropharyngeal swabs or any other relevant specimen..
- 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)
- No more than 48 hours between the onset of positive pressure respiratory support and treatment administration day
- Evidence of pulmonary infiltrates at chest imaging (chest x-ray, CT scan or LUS)
- The patient is not eligible in the Tsunami trial.
Exclusion
- 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 hours, irrespective of the provision of treatments.
- Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \<30).
- Pregnancy
- Current documented and uncontrolled bacterial infection.
Key Trial Info
Start Date :
November 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2022
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04721236
Start Date
November 19 2020
End Date
May 19 2022
Last Update
March 31 2022
Active Locations (1)
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1
Catherine Klersy
Pavia, Italy, 27100