Coronavirus Disease 2019 (COVID-19) Antibody Plasma Research Study in Hospitalized Patients
UNC CCP RCT
IGHID 12021 - A Randomized, Phase II Study Comparing the Efficacy and Safety of Standard Versus High-Titer Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody Plasma in Hospitalized Patients With COVID-19
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 covid19
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2020
CompletedFirst Posted
Study publicly available on registry
August 24, 2020
CompletedStudy Start
First participant enrolled
August 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2021
CompletedResults Posted
Study results publicly available
November 23, 2021
CompletedDecember 3, 2021
June 1, 2021
4 months
August 21, 2020
November 15, 2021
December 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Total Number of Serious Adverse Events (SAE) Through Study Day 14
Total number of SAE among all participants through Day 14; Definition of SAE per protocol and will only be included if related to COVID-19 Convalescent Plasma (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.
14 days
Median Time to Hospital Discharge (or Discharge Equivalent) Following First Dose of CCP
Median number of days to hospital discharge following first dose of CCP among all participants.
up to 28 days
Study Arms (2)
High-Titer (CCP1)
EXPERIMENTALWithin 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.
Standard-Titer (CCP2)
ACTIVE COMPARATORWithin 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.
Interventions
At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.
At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.
Eligibility Criteria
You may qualify if:
- Age at least 18 years
- Ability and willingness of participant or Legally Authorized Representative (LAR) to give written informed consent.
- Laboratory confirmed diagnosis of infection with SARS-CoV-2 by PCR
- 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.
You may not qualify if:
- Receipt of pooled immunoglobulin in past 30 days
- 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.
- 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.
- ABO-compatible titered plasma is not available
- \> 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina Health Care
Chapel Hill, North Carolina, 27514, United States
Related Publications (1)
Bartelt LA, Markmann AJ, Nelson B, Keys J, Root H, Henderson HI, Kuruc J, Baker C, Bhowmik DR, Hou YJ, Premkumar L, Cornaby C, Schmitz JL, Weiss S, Park Y, Baric R, de Silva AM, Lachiewicz A, Napravnik S, van Duin D, Margolis DM. Outcomes of Convalescent Plasma with Defined High versus Lower Neutralizing Antibody Titers against SARS-CoV-2 among Hospitalized Patients: CoronaVirus Inactivating Plasma (CoVIP) Study. mBio. 2022 Oct 26;13(5):e0175122. doi: 10.1128/mbio.01751-22. Epub 2022 Sep 22.
PMID: 36135380DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Luther Bartelt, MD
- Organization
- University of North Carolina at Chapel Hill
Study Officials
- PRINCIPAL INVESTIGATOR
Luther A Bartelt, MD
UNC-Chapel Hill
- PRINCIPAL INVESTIGATOR
David M Margolis, MD
UNC-Chapel Hill
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2020
First Posted
August 24, 2020
Study Start
August 27, 2020
Primary Completion
January 4, 2021
Study Completion
June 4, 2021
Last Updated
December 3, 2021
Results First Posted
November 23, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- 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.
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.