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Phase 3 Open-Label Controlled Trial of Convalescent Plasma in Early COVID-19 Infection

NCT06084351 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2023-10-16

No results posted yet for this study

Summary

The expanded access program for investigational convalescent plasma (CP) is being utilized nationwide despite its unproven benefit and optimal timing of transfusion. The optimal administration of CP during a viral pandemic must consider the supply of the product, ideal patient selection, and appropriate timing in order to produce maximum benefit with a scarce resource \[2\]. Currently, the FDA suggested guidelines for use include "severe", "critical" or at risk for critical disease. The optimal administration of CP with anti-SARS-CoV-2 antibodies is theoretically early in the course of the illness \[1\], before multiorgan failure or a maladaptive immune response, like seen in the cytokine release syndrome, occurs. Our open-label trial will randomize COVID-19+ patients admitted to the hospital who are at high risk for severe disease to receive 1 dose CP ordered within 48 hours of admission plus standard of care vs. standard of care. The primary clinical endpoint will be time to clinical improvement within 28 days after randomization (based on the ordinal scale as specified below). The purpose of this trial will be to obtain data which can be further utilized in future clinical trials and help clinicians understand the effectiveness of CP.

Conditions

  • Covid19

Interventions

DRUG

Convalescent Plasma

Class: Blood product Physical Description: Opaque yellow fluid within a container labelled with the statement "Caution: New Drug - Limited by Federal (or United States) law to investigational use)." Container will also be labelled with the International Society of Blood Transfusion format for Blood Components. Label will contain the expiration date and the donor identification number. Label will also contain information pertaining to the ABO typing of the plasma. A copy of the IBST identifier will be placed with the patient chart. Manufacture: Plasma will be collected via apheresis via collaboration with American Blood Bank Corporation, a FDA-registered blood establishment. The donors will be screened in accordance with the FDA guidance for donor eligibility for COVID-19:

OTHER

Standard of Care

Standard of care treatment for hospitalized COVID-19 patients

Sponsors & Collaborators

  • Larkin Community Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-12
Primary Completion
2020-10-30
Completion
2020-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06084351 on ClinicalTrials.gov