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COVID-19 Antibody Plasma Research Study in Hospitalized Patients (UNC CCP RCT)

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: NCT04524507
Recruitment Status : Recruiting
First Posted : August 24, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
The purpose of this research study is to find out if CCP is safe and to determine the safest and most effective level of anti-viral antibody when given to people admitted to the hospital with confirmed COVID-19 infection. Participants enrolled on this study will be transfused with 2 units of CCP through an IV. These units will be given one at a time 4 to 24 hours apart. Participants will be randomized to receive either 2 units with standard antibody levels as recommended by the FDA or 2 units with an antibody level higher than that recommended by the FDA. This study is experimental and CCP is investigational and has not been approved by the FDA for the treatment of COVID-19. The CCP is collected per FDA guidelines from persons recovered from COVID-19 infection. The plasma contains antibodies and possibly other properties that inhibit the virus. The investigators do not know if the level of antibodies present in the CCP will make a difference in how the participant's body is able to fight the infection and hope to learn that in this study.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: High-titer Convalescent COVID-19 Plasma (CCP1) Biological: Standard-titer Convalescent COVID-19 plasma (CCP2) Phase 2

Detailed Description:

This randomized, double-blinded, phase 2 trial will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with less than 8 days of symptoms. Eligible participants will receive institutional-guided standard-of-care (SOC) and ABO-compatible convalescent COVID-19 plasma (CCP). The CCP units will be tested for the presence of anti-SARS-CoV-2 antibodies and pre-assigned as high-titer (CCP1) or standard-titer (CCP2) in a 1:1 randomization. Participants and clinical investigators will be blinded to the CCP titer group identities.

The investigators plan to enroll approximately 56 participants (28 in each group) at UNC-Chapel Hill. Participants will be randomized within 48 hours of admission to a COVID service and will receive convalescent plasma within 24 hours of randomization. At least two units of CCP will be transfused 4-24 hours apart on study Day 0. If available, a third unit may be administered. All participants will undergo a series of safety and efficacy assessments pre-, during, and post-transfusion. Samples for research will be collected on Day 0 through Day 28, unless previously discharged. Additionally, after discharge, participants can provide longitudinal samples collected at 1, 3, and 6-month timepoints after the infusion.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This study has 2 treatment arms and participants will be assigned/randomized to one arm:

  1. CCP1 - CCP tested for the presence of anti-SARS-CoV-2 antibodies and assigned high-titer
  2. CCP2 - CCP tested for the presence of anti-SARS-CoV-2 antibodies and assigned standard-titer
Masking: Double (Participant, Investigator)
Masking Description: This study is double-blinded so neither the participant nor the study team/investigators will know which plasma treatment (CCP1 or CCP2) that the participant is receiving.
Primary Purpose: Treatment
Official Title: IGHID 12021 - A Randomized, Phase II Study Comparing the Efficacy and Safety of Standard Versus High-Titer Anti-SARS-CoV2 Neutralizing Antibody Plasma in Hospitalized Patients With COVID-19
Actual Study Start Date : August 27, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: High-Titer (CCP1)
Within 8 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive high-titer ABO-compatible convalescent COVID-19 plasma (CCP1) within 24 hours following random assignment.
Biological: High-titer Convalescent COVID-19 Plasma (CCP1)
At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.

Active Comparator: Standard-Titer (CCP2)
Within 8 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive standard-titer ABO-compatible convalescent COVID-19 plasma (CCP2) within 24 hours following random assignment.
Biological: Standard-titer Convalescent COVID-19 plasma (CCP2)
At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.




Primary Outcome Measures :
  1. Cumulative Incidence of Serious Adverse Events (SAEs) at study Day 14 [ Time Frame: 14 days ]
    Total number of SAEs among all participants at Day 14; Definition of SAE per protocol and will only be included if related to CCP: 1. Death. 2. Life-threatening (immediate risk of death). 3. Prolongation of existing hospitalization. 4. Persistent or significant disability or incapacity. OR 5. Important medical events that may not result in death, be life threatening, or require intervention or escalation of care may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias, or convulsions that do not result in inpatient hospitalization.

  2. Days to hospital discharge (or discharge equivalent) following first dose of CCP [ Time Frame: 28 days ]
    Average number of days to hospital discharge following first dose of CCP among all participants



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 to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age at least 18 years
  2. Ability and willingness of participant or Legally Authorized Representative (LAR) to give written informed consent.
  3. Laboratory confirmed diagnosis of infection with SARS-CoV-2 by PCR
  4. Hospitalized for COVID-19 with one or more respiratory or gastrointestinal (GI) symptoms:

    • COVID-19 associated respiratory symptoms include but are not limited to: cough, shortness of breath, difficulty breathing, or sore throat
    • COVID-19 associated GI symptoms include but are not limited to: loss of taste, loss of sense of smell, diarrhea, nausea, or vomiting,

Note: Respiratory and GI symptoms other than those listed above, must be noted as acceptable and signed by study PI or designee.

Exclusion Criteria:

  1. Receipt of pooled immunoglobulin in past 30 days
  2. Current or prior enrollment in a SARS-CoV-2 antibody or T-cell therapeutic study.

    Note: Patients enrolled on other randomized controlled trials of pharmaceutical and/or non-pharmaceutical interventions for COVID and meeting eligibility criteria will not be excluded, as determined by study PI (or designee) on a case-by-case basis and as allowed by eligibility criteria of the other trials.

  3. Contraindication to transfusion or history of prior reactions to transfusion blood products. This may include religious or cultural objections to receiving blood products and transfusions.
  4. ABO-compatible titered plasma is not available
  5. > 10 days from noted COVID-related subjective or objective fever at randomization. Patients without subjective or objective fever, > 10 days from symptom onset as determined by study PI.

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): NCT04524507


Contacts
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Contact: JoAnn Kuruc, RN, MSN 919-966-8533 joann_kuruc@med.unc.edu
Contact: Brian Gurney, ACNP, FNP 919-843-6848 brian_gurney@med.unc.edu

Locations
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United States, North Carolina
University of North Carolina Health Care Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: JoAnn Kuruc, RN, MSN    919-966-8533    joann_kuruc@med.unc.edu   
Contact: Brian Gurney, ACNP, FNP    919-843-6848    brian_gurney@med.unc.edu   
Principal Investigator: Luther A Bartelt, MD         
Principal Investigator: David M Margolis, MD         
Sub-Investigator: David van Duin, MD, PhD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Luther A Bartelt, MD UNC-Chapel Hill
Principal Investigator: David M Margolis, MD UNC-Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04524507    
Other Study ID Numbers: 20-1544
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator/researcher who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting Materials: Study Protocol
Analytic Code
Time Frame: 12-24 months after publication
Access Criteria: Investigators/researchers who propose to use study data will need to have IRB, IEC, or REB approval and an executed data use/sharing agreement with UNC.

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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 University of North Carolina, Chapel Hill:
COVID-19
Coronavirus
Infection
SARS-CoV-2
Randomized
Hospitalized
Plasma
Neutralizing
Antibody