COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04377568

Julia Upton, MD, MPH

julia.upton@sickkids.ca

2020-05-06

Withdrawn

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: 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

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 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.

2

The Hospital for Sick Children

0

18

Canada

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

0

Clinical recovery

None

Phase 2

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]