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

Covid-19 Infection Clinical Trial

— CONCOR-KIDS  

Official title:

A Randomized, Multicentered, Open-label Phase 2 Clinical Trial of the Safety and Efficacy of Human Coronavirus- Immune Convalescent Plasma for the Treatment of COVID-19 Disease in Hospitalized Children

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04377568
• Other study ID #: 1000070143
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 7, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: April 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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 Note: The intent of this exclusion criteria is to only include participants with acute COVID-19 infections. This protocol is not intended to include participants with post-infectious complications. In cases where the distinction is not clear, participant eligibility will be discussed with the study steering committee prior to enrollment.

Related Conditions & MeSH terms

• Coronavirus Infections
• Covid-19 Infection
• Hospitalized Children

Intervention

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

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Stollery Children's Hospital	Edmonton	Alberta
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	CHU Sainte-Justine	Montréal	Quebec
Canada	McGill Univ Health Ctr - Montreal Children's Hospital	Montréal	Quebec
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Jim Pattison Children's Hospital	Saskatoon	Saskatchewan
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	BC Children's Hospital	Vancouver	British Columbia
Canada	Winnipeg Children's Hospital	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	C17 Council (regulatory sponsor)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Virological measures 1	Proportion of patients with negative virology	at day 3
Other	Virological measures 3	Proportion of patients with negative virology	at day 10
Other	Virological measures 4	Proportion of patients with negative virology	at day 15
Other	Modulation of biomarkers	Exploratory analysis of biomarker differences between groups	up to 365 days
Other	Resolution of fever	Time to fever resolution (no longer requiring fever management)	hours
Other	Presence and titres levels	Presence and titres of IgG, IgA antibodies and neutralizing antibody titres in C19-CP group on the primary outcome and other outcomes.	at day 30
Other	Functional measure 1	efficacy of C19-CP on respiratory measures using pediatric validated dyspnea (breathlessness) scales	up to 365 days
Other	Functional measure 2	Evaluate the efficacy of C19-CP on quality of life (QOL) measures using Validated QOL scores (Eq-5D)	up to 365 days
Other	Functional measure 3	Evaluate the efficacy of C19-CP on rehospitalization after discharge	up to 365 days
Primary	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	Combined mortality/intubation	Proportion of patients experiencing death in hospital (Yes/No) 30 days	at 30 day
Secondary	Respiratory status-1	Proportion of patients experiencing Intubation (Yes/No)	at 30 days
Secondary	Respiratory status-2	time to intubation	time from admission to intubation
Secondary	Respiratory status-3	Mean number of ventilator-free days in 30 days	from admission to day 30 of hospitalization
Secondary	respiratory status -4	Mean number of ventilator days in 30 days	from admission to day 30 of hospitalization
Secondary	respiratory status -5	The number of oxygen free days in the first 30 days or the incidence and duration of new oxygen use during the trial, defined as oxygen use that was not present at time of randomization but occurs subsequently	from admission to day 30 of hospitalization
Secondary	respiratory status-6	The proportion of patients needing ECMO in 30 days	at 30 days
Secondary	Mortality 1a	Time to in-hospital death censored	at 30 days
Secondary	Mortality 1b	Time to in-hospital death censored	at 90 days
Secondary	Mortality 2a	Proportion of patients with Survival status	at 30 days
Secondary	Mortality 2b	Proportion of patients with Survival status	at 90 days
Secondary	Care and Critical Care	Length of hospitalization and stay in the ICU	at 30 days
Secondary	organ systems: renal	The proportion of patients needing renal replacement therapy	up to 365 days
Secondary	organ systems: cardiac	The proportion of patients developing myocarditis	up to 365 days
Secondary	Transfusion-associated adverse events (AE)	The proportion of patients developing adverse events to the treatment arm, C19-CP as assessed by Proposed Standard definitions for surveillance of non-infectious adverse transfusion reactions.	up to 365 days
Secondary	Safety of the intervention	cumulative incidence of severe and life-threatening AEs and severe AEs	up to 365 days
Secondary	organ systems: multi-system inflammatory disease	The proportion of patients developing multi-system inflammatory disease	up to 365 days