COVID-19Phase 2RELICNCT04723589
Restoration of Endothelial Integrity in Patients With COVID-19 (RELIC)
A Phase 2 study testing Thawed plasma in people with COVID-19, run by University of Alabama at Birmingham.
Trial summary
This is a pilot study designed to demonstrate the feasibility of conducting a larger study of standard plasma therapy in COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Thawed plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2021to 30 Apr 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- COVID-19 positive by PCR or assay within 72 hours or less
- Oxygen saturation of ≤94% on room air or requiring supplemental oxygen at screening
Who cannot join
- mechanically ventilated
- pregnant
- prisoners
- receiving resuscitation with blood products for hemorrhagic shock
- receiving an investigational therapy for COVID-19
- diagnosed with severe comorbidities
- not expected to survive more than 24 hours
About this study
This is a pilot study designed to demonstrate the feasibility of conducting a larger study of standard plasma therapy in COVID-19 patients.
Read the detailed description
This is a randomized trial in hospitalized COVID-19-positive patients. This trial compares standard care to standard care plus an infusion of non-convalescent thawed plasma. Blood will be collected from all participants at eight timepoints, and clinical data will be collected for 30 days or until discharge/death.
- Conditions
- COVID-19
- Being tested
- Thawed plasma
- Keywords
- plasma
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thawed plasmaBiological
Plasma not labeled "convalescent plasma" is presumed to be free of COVID antibodies, but is not tested for antibodies. To ensure that we are using antibody-free plasma, we will test each unit of plasma with a quick COVID test before it is utilized in this study.
| Study group | Role | What they receive |
|---|---|---|
| Standard Arm | No intervention | Participants randomized to standard care will not receive an intervention but will participate in other study procedures, which are blood collection and data collection. |
| Intervention Arm | Experimental | Participants randomized to the intervention arm will receive standard care plus an infusion of thawed plasma, starting rate 30 ml/hour for 24 hours, increased to 50 ml/hour if deemed to be hypovolemic (low fluid volume). Only non-convalescent (COVID-antibody-free) plasma will be used. Receives: Biological: Thawed plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants completing plasma infusion for COVID-19
Identification of patient population who are COVID-19-positive and transfused with plasma
Measured: Track patient progress for 30 days post transfusion.
Number of participants intubated
Participants who are intubated during hospital stay
Measured: Track patient progress for 30 days post transfusion
Secondary outcomes (16)
Sequential Organ Failure Assessment (SOFA) score change
SOFA is used as a clinical indicator of morbidity severity. The scale is 0-24, with 0 being normal.
Measured: Track patient progress for 30 days post transfusion
National Early Warning Score change
This score is used as a clinical indicator of patient deterioration. The total possible score ranges from 0 to 20. The higher the score the greater the clinical risk.
Measured: Track patient progress for 30 days post transfusion
Ventilator-free Days
Number of in-hospital days that patient is not ventilated
Measured: Track patient progress for 30 days post transfusion
Intensive care unit-free Days
Number of days patient is hospitalized and not in ICU
Measured: Track patient progress for 30 days post transfusion
In hospital mortality
Number of patients who receive transfusion but do not survive for 30 days
Measured: Track patient progress for 30 days post transfusion
Angiopoietin 1&2 blood test
Angiopoietin, a protein, that plays a role in blood vessel formation
Measured: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Soluble Tie2 blood test
Soluble Tie2 is a protein that mediates the function of angiopoietin
Measured: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Soluble Thrombomodulin blood test
This test indicates blood vessel injury
Measured: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Syndecan-1 blood test
This test indicates blood vessel injury
Measured: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Prothrombin time blood test
This test measures blood coagulation
Measured: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Partial thromboplastin time blood test
This test measures blood coagulation
Measured: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
D-dimer blood test
This test measures for D-dimer concentration, indicating that the blood has been breaking down blood clots
Measured: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Fibrinogen blood test
Tests for a protein important to clotting
Measured: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Thromboelastography blood test
Measures blood coagulation
Measured: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Von Willebrand Factor Antigen blood test
This test measures a blood clotting protein
Measured: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Factor VIII blood test
This test measures a blood clotting protein
Measured: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start30 Apr 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Why it stopped: Widespread vaccine availability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Group 1: Standard care for COVID-19 Group 2: Standard care plus non-convalescent plasma infusion
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rondi Gelbard, University of Alabama at Birmingham
- Investigators
- Rondi Gelbard, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723589
- Sponsor's protocol ID
- IRB-300005853
- Acronym
- RELIC
- Status last verified
- Jun 2021
- First submitted
- 26 Nov 2020
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Endothelial Integrity in Patients With COVID-19 (RELIC)
- ClinicalTrials.gov ID
- NCT04723589
- Acronym / sponsor ID
- RELIC / IRB-300005853
- Conditions
- COVID-19
- Keywords
- plasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Widespread vaccine availability
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study designed to demonstrate the feasibility of conducting a larger study of standard plasma therapy in COVID-19 patients.
Detailed description
This is a randomized trial in hospitalized COVID-19-positive patients. This trial compares standard care to standard care plus an infusion of non-convalescent thawed plasma. Blood will be collected from all participants at eight timepoints, and clinical data will be collected for 30 days or until discharge/death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1: Standard care for COVID-19 Group 2: Standard care plus non-convalescent plasma infusion
| Arm | Type | Receives |
|---|---|---|
| Standard Arm | No intervention | –Participants randomized to standard care will not receive an intervention but will participate in other study procedures, which are blood collection and data collection. |
| Intervention Arm | Experimental | Biological: Thawed plasmaParticipants randomized to the intervention arm will receive standard care plus an infusion of thawed plasma, starting rate 30 ml/hour for 24 hours, increased to 50 ml/hour if deemed to be hypovolemic (low fluid volume). Only non-convalescent (COVID-antibody-free) plasma will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- COVID-19 positive by PCR or assay within 72 hours or less
- Oxygen saturation of ≤94% on room air or requiring supplemental oxygen at screening
Key exclusion criteria (7 listed)
- mechanically ventilated
- pregnant
- prisoners
- receiving resuscitation with blood products for hemorrhagic shock
- receiving an investigational therapy for COVID-19
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 |
|---|---|---|
| Thawed plasmaPlasma not labeled "convalescent plasma" is presumed to be free of COVID antibodies, but is not tested for antibodies. To ensure that we are using antibody-free plasma, we will test each unit of plasma with a quick COVID test before it is utilized in this study. | Biological | Intervention Arm |
Primary outcome
Number of participants completing plasma infusion for COVID-19
Time frame: Track patient progress for 30 days post transfusion.
Identification of patient population who are COVID-19-positive and transfused with plasma
Number of participants intubated
Time frame: Track patient progress for 30 days post transfusion
Participants who are intubated during hospital stay
16 secondary outcomes
Sequential Organ Failure Assessment (SOFA) score change
Time frame: Track patient progress for 30 days post transfusion
National Early Warning Score change
Time frame: Track patient progress for 30 days post transfusion
Ventilator-free Days
Time frame: Track patient progress for 30 days post transfusion
Intensive care unit-free Days
Time frame: Track patient progress for 30 days post transfusion
In hospital mortality
Time frame: Track patient progress for 30 days post transfusion
Angiopoietin 1&2 blood test
Time frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Soluble Tie2 blood test
Time frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Soluble Thrombomodulin blood test
Time frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Syndecan-1 blood test
Time frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Prothrombin time blood test
Time frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Partial thromboplastin time blood test
Time frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
D-dimer blood test
Time frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Fibrinogen blood test
Time frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Thromboelastography blood test
Time frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Von Willebrand Factor Antigen blood test
Time frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Factor VIII blood test
Time frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Rondi Gelbard, MD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thawed plasma in people with COVID-19, run by University of Alabama at Birmingham.
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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of participants completing plasma infusion for COVID-19 (time frame: Track patient progress for 30 days post transfusion.). 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?
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 30 Jun 2021.