Restoration of Endothelial Integrity in Patients With COVID-19 (RELIC)

NCT04723589 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: IRB-300005853
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a pilot study designed to demonstrate the feasibility of conducting a larger study of standard plasma therapy in COVID-19 patients.

Conditions

COVID-19

Keywords

plasma

Outcome Measures

Primary Outcomes (2)

• Number of participants completing plasma infusion for COVID-19

  Identification of patient population who are COVID-19-positive and transfused with plasma

  Track patient progress for 30 days post transfusion.

• Number of participants intubated

  Participants who are intubated during hospital stay

  Track patient progress for 30 days post transfusion

Secondary Outcomes (16)

• Sequential Organ Failure Assessment (SOFA) score change

  Track patient progress for 30 days post transfusion

• National Early Warning Score change

  Track patient progress for 30 days post transfusion

• Ventilator-free Days

  Track patient progress for 30 days post transfusion

• Intensive care unit-free Days

  Track patient progress for 30 days post transfusion

• In hospital mortality

  Track patient progress for 30 days post transfusion

Study Arms (2)

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.

Biological: Thawed plasma

Interventions

Thawed plasma BIOLOGICAL

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rondi Gelbard, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking will not be used. Participants randomized to standard care will not receive a sham treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Surgery

Model Details: Group 1: Standard care for COVID-19 Group 2: Standard care plus non-convalescent plasma infusion

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: January 25, 2021
• Study Start: April 30, 2021
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share