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CONTAIN COVID-19: Convalescent Plasma to Limit COVID-19 Complications in Hospitalized 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: NCT04364737
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : August 28, 2020
Sponsor:
Collaborators:
National Center for Advancing Translational Science (NCATS)
Albert Einstein College of Medicine
Yale University
The University of Texas Health Science Center, Houston
The University of Texas Health Science Center at Tyler
University of Miami
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
This is a randomized, blinded phase 2 trial that will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms requiring oxygen supplementation.

Condition or disease Intervention/treatment Phase
COVID-19 Coronavirus Coronavirus Infection Biological: Convalescent Plasma Other: Saline solution Phase 2

Detailed Description:
A total of 300 eligible subjects will be randomized in a 1:1 ratio to receive either convalescent plasma (CP) from people who have recovered from COVID-19 containing antibodies to SARS-CoV-2 or a placebo control, Lactated Ringer's Solution (LR) or saline solution (SS). Hospitalized COVID-19 patients aged ≥18 years of age with respiratory symptoms within 3 to 7 days from the onset of illness OR within 3 days of hospitalization will be eligible to participate.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: CONTAIN COVID-19: Convalescent Plasma to Limit Coronavirus Associated Complications: a Randomized Blinded Phase 2 Study Comparing the Efficacy and Safety of Anti-SARS-CoV2 Plasma to Placebo in COVID-19 Hospitalized Patients
Actual Study Start Date : April 17, 2020
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Convalescent donor plasma Biological: Convalescent Plasma
SARS-CoV-2 convalescent plasma (1-2 units; ~250-500 mL) with antibodies to SARS-CoV-21 per April 13, 2020 directive by the FDA, obtained from New York Blood Center will be administered to eligible candidate

Placebo Comparator: Lactated ringer's solution or sterile saline solution Other: Saline solution
Equivalent volume of saline solution (defined as half-,quarter-, or normal saline) will be administered to eligible candidate as a placebo control group.




Primary Outcome Measures :
  1. Score on the WHO 11-point ordinal scale for clinical improvement at 14 days [ Time Frame: 14 days post randomization ]

    Uninfected 0 Uninfected; no viral RNA detected Ambulatory 1 Asymptomatic; viral RNA detected 2 Symptomatic; Independent 3 Symptomatic; assistance needed

    Hospitalized:

    Mild disease 4 Hospitalized; no oxygen therapy 5 Hospitalized; oxygen by mask or nasal prongs

    Hospitalized:

    Severe disease 6 Hospitalized; oxygen by NIV or High flow 7 Intubation & Mechanical ventilation; pO2/FIO2 >/= 150 or SpO2/FIO2 >/=200 8 Mechanical ventilation pO2/FIO2 < 150 (SpO2/FIO2 <200) or vasopressors 9 Mechanical ventilation pO2/FIO2 < 150 and vasopressors, dialysis or ECMO Death 10 Dead



Secondary Outcome Measures :
  1. Score on the WHO 11-point ordinal scale for clinical improvement at 28 days [ Time Frame: 28 days post randomization ]

    Uninfected 0 Uninfected; no viral RNA detected Ambulatory 1 Asymptomatic; viral RNA detected 2 Symptomatic; Independent 3 Symptomatic; assistance needed

    Hospitalized:

    Mild disease 4 Hospitalized; no oxygen therapy 5 Hospitalized; oxygen by mask or nasal prongs

    Hospitalized:

    Severe disease 6 Hospitalized; oxygen by NIV or High flow 7 Intubation & Mechanical ventilation; pO2/FIO2 >/= 150 or SpO2/FIO2 >/=200 8 Mechanical ventilation pO2/FIO2 < 150 (SpO2/FIO2 <200) or vasopressors 9 Mechanical ventilation pO2/FIO2 < 150 and vasopressors, dialysis or ECMO Death 10 Dead



Other Outcome Measures:
  1. Comparison in Anti-SARS-CoV-2 antibody titers [ Time Frame: 0, 1, 7, 14, 28, 90 days post randomization ]
    Anti-SARS-CoV-2 titers (IgM, IgG, IgA)

  2. Proportion positive in SARS-CoV-2 RNA [ Time Frame: 0, 7, 14, 28 days post randomization ]
    SARS-CoV-2 PCR in nasopharyngeal swabs

  3. Mortality [ Time Frame: 7, 14, 28 days post randomization ]
    Rate of mortality

  4. Rates of Intensive Care Unit admission [ Time Frame: 7, 14, 28 days post randomization ]
    Percentage of patients requiring Intensive Care Unit admission

  5. Changes from baseline in lymphocyte [ Time Frame: 0, 1, 3, 7, 14 days post randomization ]
    Lymphocyte counts

  6. Changes from baseline in neutrophils [ Time Frame: 0, 1, 3, 7, 14 days post randomization ]
    Neutrophil counts

  7. Changes from baseline in D-dimer [ Time Frame: 0, 1, 3, 7, 14 days post randomization ]
    D-dimer level

  8. Changes from baseline in fibrinogen [ Time Frame: 0, 1, 3, 7, 14 days post randomization ]
    Fibrinogen level

  9. Changes from baseline in T lymphocyte subsets [ Time Frame: 0, 7, 28 days post randomization ]
    T cell subsets

  10. Changes from baseline in B lymphocyte subsets [ Time Frame: 0, 1, 3, 7, 14 days post randomization ]
    B cell subsets



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

  1. Patients ≥18 years of age
  2. Hospitalized with laboratory confirmed COVID-19
  3. One or more of the following respiratory signs or symptoms: cough, chest pain, shortness of breath, fever, oxygen saturation ≤ 94%, abnormal CXR/CT imaging)
  4. Hospitalized for ≤ 72 hours OR within day 3 to 7 days from first signs of illness
  5. On supplemental oxygen, non-invasive ventilation or high-flow oxygen
  6. Patients may be on other randomized controlled trials of pharmaceuticals for COVID -19 and patients who meet eligibility criteria will not be excluded on this basis.

Exclusion Criteria

  1. Receipt of pooled immunoglobulin in past 30 days
  2. Contraindication to transfusion or history of prior reactions to transfusion blood products
  3. Invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
  4. Volume overload secondary to congestive heart failure or renal failure
  5. Unlikely to survive past 72 hours from screening based on the assessment of the investigator
  6. Unlikely to be able to assess and follow outcome due to poor functional status

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): NCT04364737


Contacts
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Contact: Mila B Ortigoza, MD, PhD 646-634-7803 Mila.Ortigoza@nyulangone.org
Contact: Gia Cobb Gia.Cobb@nyulangone.org

Locations
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United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Mahalia Desruisseaux, MD       mahalia.desruisseaux@yale.edu   
Principal Investigator: Mahalia Desruisseaux, MD         
United States, Florida
University of Miami Hospital and Clinics Recruiting
Miami, Florida, United States, 33136
Contact: Dushyantha Jayaweera, MD    305-243-0810      
Principal Investigator: Dushyantha Jayaweera, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Liise-Anne Pirofski, MD       l.pirofski@einsteinmed.org   
Principal Investigator: Liise-Anne Pirofski, MD         
NYU Langone Health Recruiting
New York, New York, United States, 10003
Contact: Mila Ortigoza, MD, PhD       Mila.Ortigoza@nyulangone.org   
Principal Investigator: Mila Ortigoza, MD, PhD         
United States, Texas
The University of Texas Health Science Center Recruiting
Houston, Texas, United States, 77030
Contact: Luis Ostrosky, MD       Luis.Ostrosky-Zeichner@uth.tmc.edu   
Principal Investigator: Luis Ostrosky, MD         
The University of Texas Health Science Center Recruiting
Tyler, Texas, United States, 75701
Contact: Julie Philley, MD       Julie.Philley@uthct.edu   
Principal Investigator: Julie Philley, MD         
Sponsors and Collaborators
NYU Langone Health
National Center for Advancing Translational Science (NCATS)
Albert Einstein College of Medicine
Yale University
The University of Texas Health Science Center, Houston
The University of Texas Health Science Center at Tyler
University of Miami
Investigators
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Principal Investigator: Mila B Ortigoza, MD, PhD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04364737    
Other Study ID Numbers: 20-00541
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD that underlie the results reported in this article, after deidenficiation (text, tables, figures, and appendices) will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Mila.Ortigoza@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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