Hyperimmune Plasma for Patients With COVID-19 (IMMUNO-COVID19)

The Use of Hyperimmune Plasma for the Treatment of COVID-19 Infection

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.

Study Overview

• Status: Unknown
• Conditions: Covid19
• Intervention / Treatment: Other: treated 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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Falanga; Phone Number: +39 0352674776; Email: afalanga@asst-ph23.it

Study Locations

• Italy
  • Bergamo, Italy, 24127
    • Recruiting
    • Anna Falanga
    • Contact: Anna Falanga; Email: afalanga@asst-pg23.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hyperimmune plasma; treated with hyperimmune plasma	Other: treated with hyperimmune plasma; administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5; Other Names: hyperimmune plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	death from any cause	within 30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ANNA FALANGA

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Anticipated): July 2, 2022
• Study Completion (Anticipated): July 2, 2022

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: covid19; Hospitalized patients; Hyperimmune plasma
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IMMUNO-COVID19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No