MedTrace Logo

Convalescent Plasma Collection and Treatment in Pediatrics and Adults

NCT04376034 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2020-05-06

No results posted yet for this study

Summary

This is a prospective study, involving contacting potential plasma donors and the use of their plasma to help fight off infections of those suffering from COVID19 in accordance to collection guidelines for plasma and FDA IND requirement. This study will include up to 240 participants potentially receiving convalescent plasma and up to 1000 potential donors.

There are 3 basic arms to the study: mild, moderate and severe/critical severity. All 3 severity groups are eligible for enrollment, but mild severity will not be given plasma unless there is progression. Moderate severity will given up to 1 unit of plasma and severe/critical severity up to 2 units. There is no placebo group, however given the excepted issues of shortages of plasma, intention to treat will be used for analysis.

Conditions

  • COVID19
  • Coronavirus Infection
  • Coronavirus
  • Virus Diseases
  • RNA Virus Infections

Interventions

BIOLOGICAL

Convalescent Plasma 1 Unit

Each adult recipient will receive 1 units of plasma, each unit will consist of about 200 to 250 mL. Each pediatric recipient will receive 10mL/kg up to 1 unit of plasma.

BIOLOGICAL

Convalescent Plasma 2 Units

Those that meet severe or critical criteria will be given 2 units if available or 1 unit if 2 units are not available. Those that are given 1 unit may receive the second unit (or the remainder of the maximum pediatric weight calculated amount of plasma up to 1 additional unit) if they progress to severe or critical condition or if already in severe or critical condition but only received 1 unit secondary to shortages. Each pediatric recipient will receive 10mL/kg up to 2 units of plasma.

OTHER

Standard of Care

Those that meet mild severity will be allowed to enroll in the study, but will not receive plasma unless there is progression of illness into the moderate/rapid progression or greater category.

Sponsors & Collaborators

  • West Virginia University

    lead OTHER

Principal Investigators

  • Brian Peppers, DO, PhD · WVU Medicine Children's

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
31 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-16
Primary Completion
2021-03-30
Completion
2021-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04376034 on ClinicalTrials.gov