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Hyperimmune Plasma for Critical Patients With COVID-19 (COV19-PLASMA)

Primary Purpose

COVID-19

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

hyperimmune plasma

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring hyperimmune plasma, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Catherine Klersy
Ospedale Asst Carlo Poma Mantova

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treated

Arm Description

treated with hyperimmune plasma

Outcomes

Primary Outcome Measures

death

death from any cause

Secondary Outcome Measures

time to extubation

days since intubation

length of intensive care unit stay

days from entry to exit from ICU

time to CPAP weaning

days since CPAP initiation

viral load

naso-pharyngeal swab, sputum and BAL

immune response

neutralizing title

Full Information

NCT ID

NCT04321421

First Posted

March 23, 2020

Last Updated

May 27, 2020

Sponsor

Foundation IRCCS San Matteo Hospital

Collaborators

OSPEDALE CARLO POMA ASST MANTOVA

1. Study Identification

Unique Protocol Identification Number

NCT04321421

Brief Title

Hyperimmune Plasma for Critical Patients With COVID-19

Acronym

COV19-PLASMA

Official Title

Plasma From Donors Recovered From New Coronavirus 2019 As Therapy For Critical Patients With Covid-19

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

March 17, 2020 (Actual)

Primary Completion Date

April 28, 2020 (Actual)

Study Completion Date

May 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Foundation IRCCS San Matteo Hospital

Collaborators

OSPEDALE CARLO POMA ASST MANTOVA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

hyperimmune plasma, COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Longitudinal assessment of COVID-19 patients treated with hyperimmune plasma

Masking

None (Open Label)

Allocation

N/A

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

treated

Arm Type

Experimental

Arm Description

treated with hyperimmune plasma

Intervention Type

Other

Intervention Name(s)

hyperimmune plasma

Intervention Description

administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5

Primary Outcome Measure Information:

Title

death

Description

death from any cause

Time Frame

within 7 days

Secondary Outcome Measure Information:

Title

time to extubation

Description

days since intubation

Time Frame

within 7 days

Title

length of intensive care unit stay

Description

days from entry to exit from ICU

Time Frame

within 7 days

Title

time to CPAP weaning

Description

days since CPAP initiation

Time Frame

within 7 days

Title

viral load

Description

naso-pharyngeal swab, sputum and BAL

Time Frame

at days 1, 3 and 7

Title

immune response

Description

neutralizing title

Time Frame

at days 1, 3 and 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cesare Perotti, MD

Organizational Affiliation

Foundation IRCCS San Matteo Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Catherine Klersy

City

Pavia

State/Province

ZIP/Postal Code

27100

Country

Italy

Facility Name

Ospedale Asst Carlo Poma Mantova

City

Mantova

ZIP/Postal Code

46100

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

will be decided

Citations:

PubMed Identifier

32113510

Citation

Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Apr;20(4):398-400. doi: 10.1016/S1473-3099(20)30141-9. Epub 2020 Feb 27. No abstract available.

Results Reference

background

Citation

WHO. Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected. 2020. https://www.who. int/docs/default-source/coronaviruse/clinical-management-of-novel-cov. pdf (accessed Feb 20, 2020).

Results Reference

background

PubMed Identifier

16172857

Citation

Lai ST. Treatment of severe acute respiratory syndrome. Eur J Clin Microbiol Infect Dis. 2005 Sep;24(9):583-91. doi: 10.1007/s10096-005-0004-z.

Results Reference

background

Citation

WHO. Use of convalescent whole blood or plasma collected from patients recovered from Ebola virus disease for transfusion, as an empirical treatment during outbreaks. 2014. http://apps.who.int/iris/rest/ bitstreams/604045/retrieve (accessed Feb 20, 2020).

Results Reference

background

PubMed Identifier

26618098

Citation

Arabi Y, Balkhy H, Hajeer AH, Bouchama A, Hayden FG, Al-Omari A, Al-Hameed FM, Taha Y, Shindo N, Whitehead J, Merson L, AlJohani S, Al-Khairy K, Carson G, Luke TC, Hensley L, Al-Dawood A, Al-Qahtani S, Modjarrad K, Sadat M, Rohde G, Leport C, Fowler R. Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol. Springerplus. 2015 Nov 19;4:709. doi: 10.1186/s40064-015-1490-9. eCollection 2015.

Results Reference

background

PubMed Identifier

21248066

Citation

Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.

Results Reference

background

PubMed Identifier

32004427

Citation

Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.

Results Reference

background

PubMed Identifier

34013969

Citation

Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.

Results Reference

derived

PubMed Identifier

33044747

Citation

Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.

Results Reference

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PubMed Identifier

32648959

Citation

Piechotta V, Chai KL, Valk SJ, Doree C, Monsef I, Wood EM, Lamikanra A, Kimber C, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Jul 10;7(7):CD013600. doi: 10.1002/14651858.CD013600.pub2.

Results Reference

derived

PubMed Identifier

32468508

Citation

Perotti C, Del Fante C, Baldanti F, Franchini M, Percivalle E, Vecchio Nepita E, Seminari E, De Silvestri A, Bruno R, Klersy C. Plasma from donors recovered from the new Coronavirus 2019 as therapy for critical patients with COVID-19 (COVID-19 plasma study): a multicentre study protocol. Intern Emerg Med. 2020 Aug;15(5):819-824. doi: 10.1007/s11739-020-02384-2. Epub 2020 May 28.

Results Reference

derived

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Hyperimmune Plasma for Critical Patients With COVID-19

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