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

NCT04377568 | Withdrawn Phase 2 DMC

• 1 other identifier: 1000070143
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 13

Brief 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

Keywords

covid-19; hospitalized children; convalescent plasma therapy

Outcome Measures

Primary Outcomes (1)

• Clinical recovery

  defined in the last 24 hours as normal respiratory and heart rate (or return to baseline, absence of fever, absence of low blood pressure, oxygen saturation greater than 94% or room air (or return to baseline), no need for intravenous fluids (or return to baseline)

  at day 30

Secondary Outcomes (17)

• Combined mortality/intubation

  at 30 day

• Respiratory status-1

  at 30 days

• Respiratory status-2

  time from admission to intubation

• Respiratory status-3

  from admission to day 30 of hospitalization

• respiratory status -4

  from admission to day 30 of hospitalization

Other Outcomes (9)

• Virological measures 1

  at day 3

• Virological measures 3

  at day 10

• Virological measures 4

  at day 15

Study Arms (2)

Convalescent Plasma + Standard of Care (C19-CP + SoC)

EXPERIMENTAL

Participants will receive COVID-19 convalescent plasma (C19-CP) plus standard of care while being hospitalized for COVID-19.

Biological: Convalescent plasma (CP)

Standard of Care (SoC)

NO INTERVENTION

Participants will receive standard of care while being hospitalized for COVID-19.

Interventions

Convalescent plasma (CP) BIOLOGICAL

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

Convalescent Plasma + Standard of Care (C19-CP + SoC)

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 0 to \<19 years old
• Hospitalized with symptoms compatible with COVID-19 illness
• Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen prior to randomization.
• ABO compatible convalescent plasma available

You may not qualify if:

• Onset of symptoms began \>12 days before screening
• History of adverse reactions to blood products or other contraindication to transfusion
• Refusal of plasma for religious or other reasons
• Acute heart failure with fluid overload
• Any condition or diagnosis, that could in the opinion of the Site Principal Investigator interfere with the participant's ability to comply with study instructions, or put the participant at risk
• Anticipated discharge within 24 hours

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• C17 Council (regulatory sponsor): collaborator

Study Sites (13)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

Winnipeg Children's Hospital

Winnipeg, Manitoba, R3C 1X7, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Children's Hospital

London, Ontario, N6C 2V5, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

McGill Univ Health Ctr - Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

Jim Pattison Children's Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Julia Upton, MD, MPH

  The Hospital for Sick Children

  STUDY CHAIR

• Kathy Brodeur-Robb

  C17 Council (regulatory sponsor)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician, Allergy and Immunology

Model Details: Subjects will be randomized to receive either standard of care (SoC) products (control) or COVID-19 convalescent plasma (C19-CP) plus standard of care while being hospitalized for COVID-19 (ratio 1:2). The intervention will consist of a single transfusion of convalescent plasma.

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 6, 2020
• Study Start: October 7, 2020
• Primary Completion: December 1, 2021
• Study Completion: May 1, 2022
• Last Updated: April 23, 2021

Record last verified: 2021-04

Locations

CA (13)