Hyperimmune Plasma for Patients With COVID-19

Not Applicable

• Conditions: Covid19
• Interventions: Other: treated with hyperimmune plasma

• Registration Number: NCT04614012
• Lead Sponsor: ANNA FALANGA

Brief Summary

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which originated in Wuhan, China, has become a major concern all over the world.

Convalescent plasma or immunoglobulins have been used as a last resort to improve the survival rate of patients with SARS whose condition continued to deteriorate despite treatment with pulsed methylprednisolone. Moreover, several studies showed a shorter hospital stay and lower mortality in patients treated with convalescent plasma than those who were not treated with convalescent plasma. Evidence shows that convalescent plasma from patients who have recovered from viral infections can be used effectively as a treatment of patients with active disease. To date, no specific treatment has been proven to be effective. 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 and womens , 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: 2020-07-02
• Status Verified: 2020-11
• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-02
• Last Update Submitted: 2020-11-02
• Study First Posted: 2020-11-03
• Last Update Posted: 2020-11-03
• Primary Completion: 2022-07-02
• Study Completion: 2022-07-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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) positive
• signed informed consent unless unfeasible for the critical condition

Exclusion Criteria

• 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
hyperimmune plasma	treated with hyperimmune plasma	treated with hyperimmune plasma

Primary Outcome Measures

Name	Time	Method
Death	within 30 days	death from any cause

Secondary Outcome Measures

Name	Time	Method
viral load	at days 1, 3 and 7	naso-pharyngeal swab and BAL
length of intensive care unit stay	within 7 days	days from entry to exit from ICU
length of hospitalization	within 30 days	days from entry to exit from hospital
immune response	at days 1, 3 and 7	neutralizing title
time to extubation	within 7 days	days since intubation

Trial Locations

Locations (1)

Anna Falanga; 🇮🇹 Bergamo, Italy