Hyperimmune Plasma for Patients With COVID-19

Covid19 Clinical Trial

— IMMUNO-COVID19  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04614012
• Other study ID #: IMMUNO-COVID19
• Status: Recruiting
• Phase: N/A
• Start date: July 2, 2020
• Est. completion date: July 2, 2022

Study information

• Verified date: November 2020
• Source: A.O. Ospedale Papa Giovanni XXIII
• Contact: Anna Falanga
• Phone: +39 0352674776
• Email: afalanga[@]asst-ph23.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2, 2022
• Est. primary completion date: July 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Other:
• treated with hyperimmune plasma
administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5

Locations

Country	Name	City	State
Italy	Anna Falanga	Bergamo

Sponsors (1)

Lead Sponsor	Collaborator
ANNA FALANGA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	death from any cause	within 30 days
Secondary	time to extubation	days since intubation	within 7 days
Secondary	length of intensive care unit stay	days from entry to exit from ICU	within 7 days
Secondary	length of hospitalization	days from entry to exit from hospital	within 30 days
Secondary	immune response	neutralizing title	at days 1, 3 and 7
Secondary	viral load	naso-pharyngeal swab and BAL	at days 1, 3 and 7