COVID-19Phase 2UNC CCP RCTNCT04524507

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

A Phase 2 study testing High-titer Convalescent COVID-19 Plasma (CCP1) and Standard-titer Convalescent COVID-19 plasma (CCP2) in people with COVID-19, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: COVID-19
What is being tested?: High-titer Convalescent COVID-19 Plasma (CCP1) and Standard-titer Convalescent COVID-19 plasma (CCP2)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteUnited States
Study dates: 27 Aug 2020to 4 Jun 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina Health Care
Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: COVID-19
Being tested: High-titer Convalescent COVID-19 Plasma (CCP1), Standard-titer Convalescent COVID-19 plasma (CCP2)
Keywords: COVID-19, Coronavirus, Infection, SARS-CoV-2, Randomized, Hospitalized, Plasma, Neutralizing, Antibody
Medical subject headings: COVID-19, Coronavirus Infections, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High-titer Convalescent COVID-19 Plasma (CCP1)Biological
At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.
Standard-titer Convalescent COVID-19 plasma (CCP2)Biological
At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.

Study groups in NCT04524507
Study group	Role	What they receive
High-Titer (CCP1)	Experimental	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. Receives: Biological: High-titer Convalescent COVID-19 Plasma (CCP1)
Standard-Titer (CCP2)	Active comparator	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. Receives: Biological: Standard-titer Convalescent COVID-19 plasma (CCP2)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: up to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Aug 20204 Jun 2021

First posted24 Aug 2020
Study start27 Aug 2020
Primary completion4 Jan 2021
Study completion4 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant, Investigator
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04524507
Sponsor's protocol ID: 20-1544
Acronym: UNC CCP RCT
Status last verified: Jun 2021
First submitted: 21 Aug 2020
Last updated: 3 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

Ulusan S, Markmann AJ, Vanna UP, Castillo I, Cuadra E, Mattocks M, Ekanem JA, Tart W, Mock JR, Baric RS, Premkumar L, Bartelt LA, Gunn BM. Pooled intravenous immunoglobulins exhibit broad binding and Fc-mediated activity against diverse SARS-CoV-2 variants. J Virol. 2026 Oct 22:e0147126. doi: 10.1128/jvi.01471-26. Online ahead of print.
PubMed 42910924
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.
PubMed 36135380

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04524507
Acronym / sponsor ID: UNC CCP RCT / 20-1544
Conditions: COVID-19
Keywords: COVID-19, Coronavirus, Infection, SARS-CoV-2, Randomized, Hospitalized, Plasma, Neutralizing
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Study start: 27 Aug 2020 (actual)
Primary completion: 4 Jan 2021 (actual)
Study completion: 4 Jun 2021 (actual)
First posted: 24 Aug 2020 (actual)
Results: Posted 23 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
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

Arm	Type	Receives
High-Titer (CCP1)	Experimental	Biological: High-titer Convalescent COVID-19 Plasma (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.
Standard-Titer (CCP2)	Active comparator	Biological: Standard-titer Convalescent COVID-19 plasma (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.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Biological	High-Titer (CCP1)
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.	Biological	Standard-Titer (CCP2)

Primary outcome

Total Number of Serious Adverse Events (SAE) Through Study Day 14
Time frame: 14 days
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
Time frame: up to 28 days
Median number of days to hospital discharge following first dose of CCP among all participants.

Results and safety

Results posted to the registry on 23 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High-Titer (CCP1)	15	9
Standard-Titer (CCP2)	41	18

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

Time frame: 14 days. Number. Unit: Serious Adverse Events

Measure	High-Titer (CCP1) n = 14	Standard-Titer (CCP2) n = 41
Value	0	0

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

Time frame: up to 28 days. Median (95% Confidence Interval). Unit: Days

Measure	High-Titer (CCP1) n = 14	Standard-Titer (CCP2) n = 41
Value	5 (2 to 6)	7 (3 to 20)

Adverse events

Time frame: From the time participants received the study intervention through Day 28.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High-Titer (CCP1)	2 of 14 (14.3%)	13 of 14 (92.9%)	2 of 14
Standard-Titer (CCP2)	15 of 41 (36.6%)	38 of 41 (92.7%)	10 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42910924Ulusan S, Markmann AJ, Vanna UP, Castillo I, Cuadra E, Mattocks M, Ekanem JA, Tart W, Mock JR, Baric RS, Premkumar L, Bartelt LA, Gunn BM. Pooled intravenous immunoglobulins exhibit broad binding and Fc-mediated activity against diverse SARS-CoV-2 variants. J Virol. 2026 Oct 22:e0147126. doi: 10.1128/jvi.01471-26. Online ahead of print.
Derived from this study: PubMed 36135380Bartelt 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.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Luther A Bartelt, MD principal investigator

UNC-Chapel Hill

David M Margolis, MD principal investigator

UNC-Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Number of Serious Adverse Events (SAE) Through Study Day 14 (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04524507, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.