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

NCT ID: NCT04377568

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-07
• Study Completion Date: 2022-05-01

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.

Detailed Description

SARS-CoV-2 viral infection resulting in COVID-19 disease has recently been designated by the World Health Organization as a global pandemic. Outbreak forecasting and mathematical models suggest that the number of COVID-19 cases will continue to rise over the coming weeks and months. There is an urgent public health need for rapid development of novel interventions. This protocol aims to use passive antibody therapy via convalescent plasma from SARS-CoV-2-infected patients who have developed antibody immunity, COVID-19 convalescent plasma (C19-CP), as treatment for hospitalized children with COVID-19 disease at pediatric academic hospitals across Canada. The unknown role for convalescent plasma in treating COVID-19 necessitates further study.

Conditions

Hospitalized Children; Covid-19 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Convalescent plasma (CP)

Intervention Type: BIOLOGICAL

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

Standard of Care (SoC)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Age 0 to <19 years old

2. Hospitalized with symptoms compatible with COVID-19 illness

3. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen prior to randomization.

4. ABO compatible convalescent plasma available

Exclusion Criteria

1. Onset of symptoms began >12 days before screening

2. History of adverse reactions to blood products or other contraindication to transfusion

3. Refusal of plasma for religious or other reasons

4. Acute heart failure with fluid overload

5. 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

6. Anticipated discharge within 24 hours

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C17 Council (regulatory sponsor)

UNKNOWN

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Julia Upton

Staff Physician, Allergy and Immunology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julia Upton, MD, MPH

Role: STUDY_CHAIR

The Hospital for Sick Children

Kathy Brodeur-Robb

Role: STUDY_DIRECTOR

C17 Council (regulatory sponsor)

Locations

Alberta Children's Hospital

Calgary, Alberta, Canada

Stollery Children's Hospital

Edmonton, Alberta, Canada

BC Children's Hospital

Vancouver, British Columbia, Canada

Winnipeg Children's Hospital

Winnipeg, Manitoba, Canada

IWK Health Centre

Halifax, Nova Scotia, Canada

McMaster Children's Hospital

Hamilton, Ontario, Canada

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Children's Hospital

London, Ontario, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

CHU Sainte-Justine

Montreal, Quebec, Canada

McGill Univ Health Ctr - Montreal Children's Hospital

Montreal, Quebec, Canada

Jim Pattison Children's Hospital

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

1000070143

Identifier Type: -

Identifier Source: org_study_id