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Coronavirus Disease 2019 (COVID-19) Antibody Plasma Research Study in Hospitalized Patients (UNC CCP RCT)

Primary Purpose

COVID-19

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

High-titer Convalescent COVID-19 Plasma (CCP1)

Standard-titer Convalescent COVID-19 plasma (CCP2)

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Coronavirus, Infection, SARS-CoV-2, Randomized, Hospitalized, Plasma, Neutralizing, Antibody

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

University of North Carolina Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-Titer (CCP1)

Standard-Titer (CCP2)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04524507

First Posted

August 21, 2020

Last Updated

December 1, 2021

Sponsor

University of North Carolina, Chapel Hill

1. Study Identification

Unique Protocol Identification Number

NCT04524507

Brief Title

Coronavirus Disease 2019 (COVID-19) Antibody Plasma Research Study in Hospitalized Patients

Acronym

UNC CCP RCT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

August 27, 2020 (Actual)

Primary Completion Date

January 4, 2021 (Actual)

Study Completion Date

June 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

COVID-19, Coronavirus, Infection, SARS-CoV-2, Randomized, Hospitalized, Plasma, Neutralizing, Antibody

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

This study has 2 treatment arms and participants will be assigned/randomized to one arm: CCP1 - CCP tested for the presence of anti-SARS-CoV-2 antibodies and assigned high-titer CCP2 - CCP tested for the presence of anti-SARS-CoV-2 antibodies and assigned standard-titer

Masking

ParticipantInvestigator

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.

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-Titer (CCP1)

Arm Type

Experimental

Arm Description

Arm Title

Standard-Titer (CCP2)

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

High-titer Convalescent COVID-19 Plasma (CCP1)

Intervention Description

At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.

Intervention Type

Biological

Intervention Name(s)

Standard-titer Convalescent COVID-19 plasma (CCP2)

Intervention Description

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 Measure Information:

Title

Total Number of Serious Adverse Events (SAE) Through Study Day 14

Description

Time Frame

14 days

Title

Median Time to Hospital Discharge (or Discharge Equivalent) Following First Dose of CCP

Description

Median number of days to hospital discharge following first dose of CCP among all participants.

Time Frame

up to 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luther A Bartelt, MD

Organizational Affiliation

UNC-Chapel Hill

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David M Margolis, MD

Organizational Affiliation

UNC-Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina Health Care

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing Time Frame

12-24 months after publication

IPD Sharing 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.

Citations:

PubMed Identifier

36135380

Citation

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.

Results Reference

derived

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Coronavirus Disease 2019 (COVID-19) Antibody Plasma Research Study in Hospitalized Patients

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