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

NCT ID: NCT04723589

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2021-04-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Arm

Participants randomized to standard care will not receive an intervention but will participate in other study procedures, which are blood collection and data collection.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Arm

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.

Group Type: EXPERIMENTAL

Thawed plasma

Intervention Type: 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.

Interventions

Thawed plasma

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 Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Rondi Gelbard

Associate Professor, Department of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rondi Gelbard, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Other Identifiers

IRB-300005853

Identifier Type: -

Identifier Source: org_study_id