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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

Tracking Information
First Submitted Date  ICMJE March 23, 2020
First Posted Date  ICMJE March 25, 2020
Last Update Posted Date May 28, 2020
Actual Study Start Date  ICMJE March 17, 2020
Actual Primary Completion Date April 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
death [ Time Frame: within 7 days ]
death from any cause
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
  • time to extubation [ Time Frame: within 7 days ]
    days since intubation
  • length of intensive care unit stay [ Time Frame: within 7 days ]
    days from entry to exit from ICU
  • time to CPAP weaning [ Time Frame: within 7 days ]
    days since CPAP initiation
  • viral load [ Time Frame: at days 1, 3 and 7 ]
    naso-pharyngeal swab, sputum and BAL
  • immune response [ Time Frame: at days 1, 3 and 7 ]
    neutralizing title
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperimmune Plasma for Critical Patients With COVID-19
Official Title  ICMJE Plasma From Donors Recovered From New Coronavirus 2019 As Therapy For Critical Patients With Covid-19
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE COVID-19
Intervention  ICMJE Other: hyperimmune plasma
administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5
Study Arms  ICMJE Experimental: treated
treated with hyperimmune plasma
Intervention: Other: hyperimmune plasma
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2020)
49
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 7, 2020
Actual Primary Completion Date April 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04321421
Other Study ID Numbers  ICMJE IRCCSSanMatteoH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: will be decided
Responsible Party Cesare Perotti, Foundation IRCCS San Matteo Hospital
Study Sponsor  ICMJE Foundation IRCCS San Matteo Hospital
Collaborators  ICMJE OSPEDALE CARLO POMA ASST MANTOVA
Investigators  ICMJE
Principal Investigator: Cesare Perotti, MD Foundation IRCCS San Matteo Hospital
PRS Account Foundation IRCCS San Matteo Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP