Name (Synonyms) | Correlation |
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Name (Synonyms) | Correlation |
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There is one clinical trial.
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: 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)
Measure: Clinical recovery Time: at day 30Description: Proportion of patients experiencing death in hospital (Yes/No) 30 days
Measure: Combined mortality/intubation Time: at 30 dayDescription: Proportion of patients experiencing Intubation (Yes/No)
Measure: Respiratory status-1 Time: at 30 daysDescription: time to intubation
Measure: Respiratory status-2 Time: time from admission to intubationDescription: Mean number of ventilator-free days in 30 days
Measure: Respiratory status-3 Time: from admission to day 30 of hospitalizationDescription: Mean number of ventilator days in 30 days
Measure: respiratory status -4 Time: from admission to day 30 of hospitalizationDescription: 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
Measure: respiratory status -5 Time: from admission to day 30 of hospitalizationDescription: The proportion of patients needing ECMO in 30 days
Measure: respiratory status-6 Time: at 30 daysDescription: Time to in-hospital death censored
Measure: Mortality 1a Time: at 30 daysDescription: Time to in-hospital death censored
Measure: Mortality 1b Time: at 90 daysDescription: Proportion of patients with Survival status
Measure: Mortality 2a Time: at 30 daysDescription: Proportion of patients with Survival status
Measure: Mortality 2b Time: at 90 daysDescription: Length of hospitalization and stay in the ICU
Measure: Care and Critical Care Time: at 30 daysDescription: The proportion of patients needing renal replacement therapy
Measure: organ systems: renal Time: up to 365 daysDescription: The proportion of patients developing myocarditis
Measure: organ systems: cardiac Time: up to 365 daysDescription: 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.
Measure: Transfusion-associated adverse events (AE) Time: up to 365 daysDescription: cumulative incidence of severe and life-threatening AEs and severe AEs
Measure: Safety of the intervention Time: up to 365 daysDescription: Proportion of patients with negative virology
Measure: Virological measures 1 Time: at day 3Description: Proportion of patients with negative virology
Measure: Virological measures 2 Time: at day 5Description: Proportion of patients with negative virology
Measure: Virological measures 3 Time: at day 10Description: Proportion of patients with negative virology
Measure: Virological measures 4 Time: at day 15Description: Exploratory analysis of biomarker differences between groups
Measure: Modulation of biomarkers Time: up to 365 daysDescription: Time to fever resolution (no longer requiring fever management)
Measure: Resolution of fever Time: hoursDescription: Presence and titres of IgG, IgA antibodies and neutralizing antibody titres in C19-CP groupon rates of intubation for mechanical ventilation or death in hospital
Measure: Presence and titres levels Time: at 30 daysDescription: efficacy of C19-CP on respiratory measures using pediatric validated dyspnea (breathlessness) scales
Measure: Functional measure 1 Time: up to 365 daysDescription: Evaluate the efficacy of C19-CP on quality of life (QOL) measures using Validated QOL scores (Eq-5D)
Measure: Functional measure 2 Time: up to 365 daysDescription: Evaluate the efficacy of C19-CP on rehospitalization after discharge
Measure: Functional measure 3 Time: up to 365 days