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Convalescent plasma (CP)Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug2135 SARS-CoV-2 convalescent plasma treatment Wiki 1.00
drug2314 Standard care Wiki 0.38

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 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

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.

NCT04377568 Hospitalized Children Covid-19 Infection Biological: Convalescent plasma (CP)
MeSH:Coronavirus Infections

Primary Outcomes

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 30

Secondary Outcomes

Description: Proportion of patients experiencing death in hospital (Yes/No) 30 days

Measure: Combined mortality/intubation

Time: at 30 day

Description: Proportion of patients experiencing Intubation (Yes/No)

Measure: Respiratory status-1

Time: at 30 days

Description: time to intubation

Measure: Respiratory status-2

Time: time from admission to intubation

Description: Mean number of ventilator-free days in 30 days

Measure: Respiratory status-3

Time: from admission to day 30 of hospitalization

Description: Mean number of ventilator days in 30 days

Measure: respiratory status -4

Time: from admission to day 30 of hospitalization

Description: 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 hospitalization

Description: The proportion of patients needing ECMO in 30 days

Measure: respiratory status-6

Time: at 30 days

Description: Time to in-hospital death censored

Measure: Mortality 1a

Time: at 30 days

Description: Time to in-hospital death censored

Measure: Mortality 1b

Time: at 90 days

Description: Proportion of patients with Survival status

Measure: Mortality 2a

Time: at 30 days

Description: Proportion of patients with Survival status

Measure: Mortality 2b

Time: at 90 days

Description: Length of hospitalization and stay in the ICU

Measure: Care and Critical Care

Time: at 30 days

Description: The proportion of patients needing renal replacement therapy

Measure: organ systems: renal

Time: up to 365 days

Description: The proportion of patients developing myocarditis

Measure: organ systems: cardiac

Time: up to 365 days

Description: 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 days

Description: cumulative incidence of severe and life-threatening AEs and severe AEs

Measure: Safety of the intervention

Time: up to 365 days

Description: The proportion of patients developing multi-system inflammatory disease

Measure: organ systems: multi-system inflammatory disease

Time: up to 365 days

Other Outcomes

Description: Proportion of patients with negative virology

Measure: Virological measures 1

Time: at day 3

Description: Proportion of patients with negative virology

Measure: Virological measures 2

Time: at day 5

Description: Proportion of patients with negative virology

Measure: Virological measures 3

Time: at day 10

Description: Proportion of patients with negative virology

Measure: Virological measures 4

Time: at day 15

Description: Exploratory analysis of biomarker differences between groups

Measure: Modulation of biomarkers

Time: up to 365 days

Description: Time to fever resolution (no longer requiring fever management)

Measure: Resolution of fever

Time: hours

Description: Presence and titres of IgG, IgA antibodies and neutralizing antibody titres in C19-CP group on the primary outcome and other outcomes.

Measure: Presence and titres levels

Time: at day 30

Description: efficacy of C19-CP on respiratory measures using pediatric validated dyspnea (breathlessness) scales

Measure: Functional measure 1

Time: up to 365 days

Description: 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 days

Description: Evaluate the efficacy of C19-CP on rehospitalization after discharge

Measure: Functional measure 3

Time: up to 365 days

No related HPO nodes (Using clinical trials)