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Efficacy of Human Coronavirus-immune Convalescent Plasma for the Treatment of COVID-19 Disease in Hospitalized Children

NCT04377568 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-04-23

No results posted yet for this study

Summary

This is a multicentered, open-label, randomized controlled Phase 2 trial to evaluate the safety and efficacy of providing human coronavirus-immune convalescent plasma as treatment for COVID-19 disease in hospitalized children in the context of the COVID-19 pandemic.

Conditions

  • Hospitalized Children
  • Covid-19 Infection

Interventions

BIOLOGICAL

Convalescent plasma (CP)

Participants will receive one infusion of convalescent plasma proportional to their weight (10 mL/kg), up to a maximum of 500 mL

Sponsors & Collaborators

  • C17 Council (regulatory sponsor)

    collaborator UNKNOWN

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Julia Upton, MD, MPH · The Hospital for Sick Children

  • Kathy Brodeur-Robb · C17 Council (regulatory sponsor)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2021-12-01
Completion
2022-05-01

Countries

  • Canada

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 NCT04377568 on ClinicalTrials.gov