Hyperimmune Plasma for Critical Patients With COVID-19

Not Applicable

Completed

• Conditions: COVID-19
• Interventions: Other: hyperimmune plasma

• Registration Number: NCT04321421
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Brief Summary

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has become pandemic. To date, no specific treatment has been proven to be effective. Promising results were obtained in China using Hyperimmune plasma from patients recovered from the disease.The investigators plan to treat critical Covid-19 patients with hyperimmune plasma.

Detailed Description

Apheresis from recovered donors will be performed with a cell separator device , with 500-600 mL of plasma obtained from each donor. Donors are males, age 18 yrs or more, evaluated for transmissible diseases according to the italian law. Adjunctive tests will be for hepatitis A virus, hepatitis E virus and Parvovirus B-19. All donors will be tested for the Covid-19 neutralizing title. Each plasma bag obtained from plasmapheresis will be immediately divided in two units and frozen according to the national standards and stored separately.

Based on experience published in literature 250-300 mL of convalescent plasma will be used to treat each of the recruited patients at most 3 times over 5 days.

Study Timeline

• Study Start: 2020-03-17
• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-25
• Primary Completion: 2020-04-28
• Status Verified: 2020-05
• Study Completion: 2020-05-07
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• age >=18 yrs
• positive for reverse transcription polymerase chain reaction (RT-PCR) severe acute respiratory syndrome (SARS)-CoV-2
• Acute respiratory distress syndrome (ARDS) moderate to severe, according to Berlin definition, lasting less than10 days
• Polymerase chain reaction (PCR) increased by 3.5 with respect to baseline or >1.8 mg/dl
• need for mechanical ventilation or continuous positive airway pressure (CPAP)
• signed informed consent unless unfeasible for the critical condition

Exclusion Criteria

• Moderate to severe ARDS lasting more than 10 days
• proven hypersensitivity or allergic reaction to hemoderivatives or immunoglobulins
• consent denied

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treated	hyperimmune plasma	treated with hyperimmune plasma

Primary Outcome Measures

Name	Time	Method
death	within 7 days	death from any cause

Secondary Outcome Measures

Name	Time	Method
length of intensive care unit stay	within 7 days	days from entry to exit from ICU
immune response	at days 1, 3 and 7	neutralizing title
time to CPAP weaning	within 7 days	days since CPAP initiation
viral load	at days 1, 3 and 7	naso-pharyngeal swab, sputum and BAL
time to extubation	within 7 days	days since intubation

Trial Locations

Locations (2)

Catherine Klersy; 🇮🇹 Pavia, PV, Italy

Ospedale Asst Carlo Poma Mantova; 🇮🇹 Mantova, Italy