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

The University of Alabama at Birmingham

Status and phase: Withdrawn; Phase 2

Conditions: COVID-19

Treatments: Biological: Thawed plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04723589

IRB-300005853

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Standard Arm

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Biological: Thawed plasma