Convalescent Plasma Collection and Treatment in Pediatrics and Adults

NCT04376034 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 2004965705
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study, using plasma to help fight off infections of those suffering from COVID-19 in accordance with collection guidelines for plasma and FDA IND requirements. This study included up to 240 participants potentially receiving convalescent plasma. NOTE: West Virginia does not have any entity with the required FDA registration/licensure or necessary equipment to collect convalescent plasma for transfusion. Therefore, the plasma donation portion of this study was not completed.

Conditions

COVID19; Coronavirus Infection; Coronavirus; Virus Diseases; RNA Virus Infections

Keywords

Covid19; Covid 19; Convalescent Plasma; SARS-CoV-2; Pediatric; Pediatrics

Outcome Measures

Primary Outcomes (5)

• Time of Meeting Infusion Criteria to Infusion

  Time from meeting protocol-specified infusion criteria to the start of convalescent plasma infusion, measured in days.

  up to 30 days

• Plasma Recipient Survival

  Number of participants who were alive 30 days after hospital discharge.

  30 days from discharge

• Identify Plasma Donor

  Time it takes to identify eligible donors whom are willing to donate. Measured in days for 365 days

  365 days

• Outreach to Plasma Donor

  Time it takes the plasma collection center to contact willing donors whom are allowed to donate plasma Measured in days for 365 days

  365 days

• Plasma Donor Time Until Donated

  Time until plasma is donated Measured every 24 hours up to 1 year

  up to 1 year

Secondary Outcomes (10)

• Plasma Recipient Mortality

  Up to 1 year

• Plasma Recipient LOS

  up to 1 year

• Plasma Recipient AE (Day 1)

  Day 1

• Plasma Recipient AE (Day 2)

  Day 2

• Plasma Recipient AE (Day 3)

  Day 3

Study Arms (1)

Convalescent Plasma

EXPERIMENTAL

Convalescent Plasma containing SARS-CoV-2 antibodies will be given to eligible recipients within the hospital setting that fit eligibility requirements, the recipient's condition, and the availability of the plasma.

Biological: Convalescent Plasma

Interventions

Convalescent Plasma BIOLOGICAL

1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations. An additional unit of plasma will be given every 3 days up to 8 units if patient was not improving or getting worse. All pediatric patients will receive 10 mL/kg (1 dose) if moderate with concern for rapid progression up to 1 Unit; 10 mL/kg up to 2 units if severe or critical.

Convalescent Plasma

Eligibility Criteria

• Age: 31 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Plasma donation:
• Prior diagnosis of COVID-19 documented by a laboratory test
• Abbott RealTime SARS-CoV-2 real-time reverse transcription polymerase chain reaction (rRT-PCR) test on the Abbott m2000 System (Inpatient WVU testing)
• Other testing methods and vendors using FDA approved detection methods of SARS-CoV-2 under the Emergency Use Authorization (EUA)
• Complete resolution of symptoms at least 28 days prior to donation
• Complete resolution of symptoms for at least 14 days with negative repeat COVID-19 testing approved by the FDA EUA
• Female donors age 18+ that have never been pregnant or negative for HLA antibodies
• Male donors age 18+
• Negative results for COVID-19 either from one or more nasopharyngeal swab specimens or by a molecular diagnostic test from blood. A partial list of available tests can be accessed at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.
• Defined SARS-CoV-2 neutralizing antibody titers, if testing can be conducted (e.g., of at least 1:1602, 1:360 up to 1:640 is preferred. In shortage case 1:80 is acceptable)
• At least or greater than 50kg of weight
• Plasma Recipients:
• Individuals of any age above 30 days of life, sex, or pregnancy status suffering from confirmed COVID19 and in rapid progression, severe or critical condition meeting the FDA IND guidelines.
• Must have laboratory confirmed COVID19
• Must have severe or immediately life-threatening COVID19

You may not qualify if:

• Plasma donation:
• Individuals that do not meet the requirement from the American Red Cross for plasma donation or equivalent
• Individuals plasma that has not passed safety screening after procurement by the American Red Cross for plasma donation or equivalent
• Plasma Recipients
• Individuals with COVID19 who are not in clinical concern for rapid progression, severe or critical condition
• Individuals who are in critical condition that are not confirmed to have COVID19
• Individuals with known Selective IgA Deficiency, that has not been found to be absent of anti-IgA antibodies

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

WVU Medicine

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Virus Diseases; RNA Virus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The plasma donor component of the original protocol was withdrawn due to lack of FDA-licensed plasma collection capability in West Virginia. West Virginia, as a State, does not have a single entity that has the FDA registration or licensure and the equipment on site required to collect plasma for the purpose of plasma transfusion. Therefore, donor-related outcomes have zero participants enrolled or analyzed.

Results Point of Contact

• Title: Brian P. Peppers , DO, PhD
• Organization: West Virginia University

brian.peppers@hsc.wvu.edu

304-594-1313

Study Officials

• Brian Peppers, DO, PhD

  WVU Medicine Children's

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: May 6, 2020
• Study Start: April 16, 2020
• Primary Completion: February 28, 2021
• Study Completion: April 21, 2021
• Last Updated: May 29, 2026
• Results First Posted: May 29, 2026

Record last verified: 2026-05

Locations

US (1)