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Plasma Therapy of COVID-19 in Severely 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04359810
Recruitment Status : Completed
First Posted : April 24, 2020
Last Update Posted : May 18, 2021
Sponsor:
Collaborators:
New York Blood Center
Amazon.com, Inc.
Information provided by (Responsible Party):
Max O'Donnell, Columbia University

Brief Summary:
This randomized blinded multi-center 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 219 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-2 Infection Biological: Convalescent Plasma (anti-SARS-CoV-2 plasma) Biological: Non-convalescent Plasma (control plasma) Phase 2

Detailed Description:
There are few effective therapies for coronavirus disease 2019 (COVID-19) associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. 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-CoV). Small clinical trials and observational studies of CP therapy in patients with COVID-19 have suggested a possible clinical benefit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A total of 219 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, Multi-Center, 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
Actual Primary Completion Date : December 30, 2020
Actual Study Completion Date : December 30, 2020

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. Day 28 severity outcome [ Time Frame: Up to 28 days ]
    Compare the day 28 severity outcome amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups using a 7-point ordinal scale of clinical status.


Secondary Outcome Measures :
  1. Proportion of SARS-CoV-2 PCR Positivity [ Time Frame: Up to 14 days ]
    Compare the proportion and duration of SARS-CoV-2 PCR positivity (via RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups at days 0, 7, and 14.

  2. Levels of SARS-CoV-2 RNA [ Time Frame: Up to 14 days ]
    Compare levels of SARS-CoV-2 RNA amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups at days 0, 7, and 14.

  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 and 28-day mortality [ 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.

  6. Time-to-clinical improvement in-hospital [ Time Frame: Up to 28 days ]
    Compare time-to-clinical improvement in-hospital amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups, defined as the time to either an improvement of one point on a 7-point ordinal scale of clinical status or alive discharge from the hospital, whichever comes first.

  7. Host genetic differences at day 0 [ Time Frame: Day 0 ]
    To assess for host genetic differences at Day 0 amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups.

  8. Host transcriptomic differences at days 0,7,14 [ Time Frame: Up to 14 days ]
    To assess for host transcriptomic differences at Day 0,7,14 amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 naso-/oro-pharyngeal swab or tracheal aspirate sample within 14 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 [1]
  • 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

    1. Use of remdesivir as treatment for COVID-19 is permitted.

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


Locations
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United States, New York
Columbia University Irving Medical Center/NYP
New York, New York, United States, 10032
Brazil
Hospital Federal dos Servidores do Estado
Rio De Janeiro, Brazil
Hospital Geral de Nova Iguaçu
Rio De Janeiro, Brazil
Instituto Nacional de Infectologia Evandro Chagas
Rio De Janeiro, Brazil
Sponsors and Collaborators
Max O'Donnell
New York Blood Center
Amazon.com, Inc.
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 O'Donnell, Florence Irving Associate 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: May 18, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data-sharing plans for this study will be made available at a later date.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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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 O'Donnell, Columbia University:
COVID-19
COVID
Coronavirus
Convalescent plasma
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases