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Plasma Therapy of COVID-19 in Critically Ill Patients

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04359810
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 30, 2020
Sponsor:
Collaborator:
New York Blood Center
Information provided by (Responsible Party):
Max R. O'Donnell, Columbia University

Brief Summary:
This randomized blinded phase 2 trial will assess the efficacy and safety of Anti-SARS-CoV-2 convalescent plasma among adults with severe COVID-19. Adults ≥18 years of age may participate. A total of 105 eligible subjects will be randomized in a 2:1 ratio to receive either high-titer anti-SARS-CoV-2 plasma or non-convalescent fresh frozen plasma (control plasma).

Condition or disease Intervention/treatment Phase
SARS-CoV Infection Biological: Convalescent Plasma (anti-SARS-CoV-2 plasma) Biological: Non-convalescent Plasma (control plasma) Phase 2

Detailed Description:
There are no approved therapies for Coronavirus disease 2019 (COVID-19), also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Exposure to viruses results in an adaptive immune response that commonly include antibodies with neutralization activity. Plasma from subjects who have recovered from viral infections has been used to both prevent or treat disease. Notable examples of the successful use of convalescent plasma (CP) include influenza, measles, Argentine hemorrhagic fever, Middle East respiratory syndrome (MERS), Ebola and severe acute respiratory syndrome (SARS). In recent work in China, an open label safety trial of CP in patients with COVID-19 suggested a substantive benefit.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A total of 105 eligible subjects will be randomized in a 2:1 ratio to receive either convalescent plasma qualitatively positive for SARS-CoV-2 antibody (anti-SARS-CoV-2 plasma) or non-convalescent fresh frozen plasma (control plasma).
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Human Anti-SARS-CoV-2 Convalescent Plasma in Severely Ill Adults With COVID-19
Actual Study Start Date : April 21, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Convalescent Plasma (anti-SARS-CoV-2 plasma)
Convalescent plasma (1 unit; ~200-250 mL) collected from a volunteer who recovered from COVID-19 disease
Biological: Convalescent Plasma (anti-SARS-CoV-2 plasma)
Convalescent Plasma that contains antibody titers against SARS-CoV-2

Active Comparator: Non-convalescent Plasma (control plasma)
Non-convalescent plasma (1 unit; ~200-250 mL) of standard plasma collected prior to December 2019
Biological: Non-convalescent Plasma (control plasma)
Non-convalescent plasma (does not contain antibody titers against SARS-CoV-2)




Primary Outcome Measures :
  1. Time to Improvement [ Time Frame: Up to 28 days ]
    The efficacy of treatment will be determined by determining the time-to-clinical improvement, defined as the time from randomization to either an improvement of one point on a seven-category ordinal scale or alive discharge from the hospital, whichever comes first.


Secondary Outcome Measures :
  1. Rate of SARS-CoV-2 PCR Positivity [ Time Frame: Up to 14 days ]
    Compare the rates of SARS-CoV-2 PCR positivity (RT PCR) amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups.

  2. Duration of SARS-CoV-2 PCR Positivity [ Time Frame: Up to 14 days ]
    Compare the duration of SARS-CoV-2 PCR positivity (RT PCR) amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups.

  3. Duration of Need for Supplemental Oxygen [ Time Frame: Up to 28 days ]
    Compare duration of need for supplemental oxygen and/or mechanical ventilation amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups.

  4. Duration of Hospitalization [ Time Frame: Up to 28 days ]
    Compare duration of hospitalization amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups.

  5. In-hospital 28-day Mortality Rate [ Time Frame: Up to 28 days ]
    Compare in-hospital and 28-day mortality amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups.



Information from the National Library of Medicine

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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:

  • Willing and able to provide written informed consent prior to performing study procedures or have a legally authorized representative available to do so.
  • Age ≥18 years
  • Evidence of SARS-CoV-2 infection by PCR test of nasopharyngeal swab sample within 7 days of randomization
  • Peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen, non-invasive or invasive mechanical ventilation at screening
  • Evidence of infiltrates on chest radiography
  • Females of childbearing age and males, must be willing to practice an effective contraceptive method or remain abstinent during the study period.

Exclusion Criteria:

  • Participation in another clinical trial of anti-viral agent(s) for COVID-19
  • Receipt of any anti-viral agent(s) with possible activity against SARS-CoV-2 <24 hours prior to study drug administration
  • Mechanically ventilated (including veno-venous (VV)-ECMO) ≥ 5 days
  • Severe multi-organ failure
  • History of prior reactions to transfusion blood products meeting definitive case definition criteria, at least severe severity, and probable or definite imputability per National Healthcare Safety Network (NHSN)/Centers for Disease Control and Prevention (CDC) criteria
  • Known Immunoglobulin A (IgA) deficiency
  • Females who are pregnant

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): NCT04359810


Contacts
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Contact: Max O'Donnell, MD 212-305-5794 mo2130@cumc.columbia.edu
Contact: Andrew Eisenberger, MD 212-305-0983 abe6@cumc.columbia.edu

Locations
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United States, New York
Columbia University Irving Medical Center/NYP Recruiting
New York, New York, United States, 10032
Contact: Max O'Donnell, MD    212-305-5794    mo2130@cumc.columbia.edu   
Contact: Walter I. Lipkin, MD    646-361-2525    wil2001@cumc.columbia.edu   
Sponsors and Collaborators
Max R. O'Donnell
New York Blood Center
Investigators
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Principal Investigator: Max O'Donnell, MD Columbia University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Max R. O'Donnell, Florence Irving Assistant Professor of Medicine and Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT04359810    
Other Study ID Numbers: AAAS9924
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Max R. O'Donnell, Columbia University:
COVID-19
COVID
Coronavirus
Convalescent plasma
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases