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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04321421
Recruitment Status : Completed
First Posted : March 25, 2020
Last Update Posted : May 28, 2020
Sponsor:
Collaborator:
OSPEDALE CARLO POMA ASST MANTOVA
Information provided by (Responsible Party):
Cesare Perotti, Foundation IRCCS San Matteo Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Other: hyperimmune plasma Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Longitudinal assessment of COVID-19 patients treated with hyperimmune plasma
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Plasma From Donors Recovered From New Coronavirus 2019 As Therapy For Critical Patients With Covid-19
Actual Study Start Date : March 17, 2020
Actual Primary Completion Date : April 28, 2020
Actual Study Completion Date : May 7, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: treated
treated with hyperimmune plasma
 Other: hyperimmune plasma
administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5


Outcome Measures
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Primary Outcome Measures :
  1. death [ Time Frame: within 7 days ]
    death from any cause


Secondary Outcome Measures :
  1. time to extubation [ Time Frame: within 7 days ]
    days since intubation

  2. length of intensive care unit stay [ Time Frame: within 7 days ]
    days from entry to exit from ICU

  3. time to CPAP weaning [ Time Frame: within 7 days ]
    days since CPAP initiation

  4. viral load [ Time Frame: at days 1, 3 and 7 ]
    naso-pharyngeal swab, sputum and BAL

  5. immune response [ Time Frame: at days 1, 3 and 7 ]
    neutralizing title


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321421


Locations
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Italy
Catherine Klersy
Pavia, PV, Italy, 27100
Ospedale Asst Carlo Poma Mantova
Mantova, Italy, 46100
Sponsors and Collaborators
Foundation IRCCS San Matteo Hospital
OSPEDALE CARLO POMA ASST MANTOVA
Investigators
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Principal Investigator: Cesare Perotti, MD Foundation IRCCS San Matteo Hospital
More Information
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Publications:
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).
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).

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cesare Perotti, Head, Immunohematology & Transfusion Service, Foundation IRCCS San Matteo Hospital
ClinicalTrials.gov Identifier: NCT04321421    
Other Study ID Numbers: IRCCSSanMatteoH
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: will be decided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cesare Perotti, Foundation IRCCS San Matteo Hospital:
hyperimmune plasma
COVID-19
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases