Clinical trial NCT04377568: Efficacy of Human Coronavirus-immune Convalescent Plasma for the Treatment of COVID-19 Disease in Hospitalized Children
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hospitalized Children
Covid-19 Infection
Keywords: covid-19
hospitalized children
convalescent plasma therapy
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: C17 Council (regulatory sponsor)
First posted: 2020-05-06
Enrollment: 0
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

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.

Primary outcomes:
measure: Clinical recovery
timeFrame: at day 30
Secondary outcomes:
measure: Combined mortality/intubation
timeFrame: at 30 day
measure: Respiratory status-1
timeFrame: at 30 days
measure: Respiratory status-2
timeFrame: time from admission to intubation
measure: Respiratory status-3
timeFrame: from admission to day 30 of hospitalization
measure: respiratory status -4
timeFrame: from admission to day 30 of hospitalization
measure: respiratory status -5
timeFrame: from admission to day 30 of hospitalization
measure: respiratory status-6
timeFrame: at 30 days
measure: Mortality 1a
timeFrame: at 30 days
measure: Mortality 1b
timeFrame: at 90 days
measure: Mortality 2a
timeFrame: at 30 days
measure: Mortality 2b
timeFrame: at 90 days
measure: Care and Critical Care
timeFrame: at 30 days
measure: organ systems: renal
timeFrame: up to 365 days
measure: organ systems: cardiac
timeFrame: up to 365 days
measure: Transfusion-associated adverse events (AE)
timeFrame: up to 365 days
measure: Safety of the intervention
timeFrame: up to 365 days
measure: organ systems: multi-system inflammatory disease
timeFrame: up to 365 days
Other outcomes:
measure: Virological measures 1
timeFrame: at day 3
measure: Virological measures 3
timeFrame: at day 10
measure: Virological measures 4
timeFrame: at day 15
measure: Modulation of biomarkers
timeFrame: up to 365 days
measure: Resolution of fever
timeFrame: hours
measure: Presence and titres levels
timeFrame: at day 30
measure: Functional measure 1
timeFrame: up to 365 days
measure: Functional measure 2
timeFrame: up to 365 days
measure: Functional measure 3
timeFrame: up to 365 days
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Children's Hospital
state: Manitoba
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: Children's Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Montréal
country: Canada
facility: McGill Univ Health Ctr - Montreal Children's Hospital
state: Quebec
city: Saskatoon
country: Canada
facility: Jim Pattison Children's Hospital
state: Saskatchewan
Study officials:
affiliation: The Hospital for Sick Children
name: Julia Upton, MD, MPH
role: STUDY_CHAIR
affiliation: C17 Council (regulatory sponsor)
name: Kathy Brodeur-Robb
role: STUDY_DIRECTOR
References: