An Early Phase 1 interventional study of Convalescent Plasma (CP) and Standard COVID-19 therapies in COVID, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 0 Years to 22 Years. Per ClinicalTrials.gov, last updated 2021-11-22.
Sponsored by Emory University · Early Phase 1, Interventional, and Treatment
COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been adequately studied in children to date. The study will determine safety of convalescent plasma for pediatric patients with severe, or at high risk for severe, COVID-19 disease.
COVID19 is an emerging infection with no current approved treatment or prevention. COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been adequately studied in children to date. The study will determine safety of convalescent plasma for pediatric patients with severe, or at high risk for severe, COVID-19 disease.
7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 3 is below the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Inclusion criteria for infusion:
Exclusion to infusion:
Once the patient meets criteria for CP infusion (severity of disease and risk factor determination and absence of exclusion criteria) convalescent plasma will be administered
Biological: Convalescent Plasma (CP) · Drug: Standard COVID-19 therapies
Once the patient meets criteria for CP infusion (severity of disease and risk factor determination and absence of exclusion criteria), an ABO compatible product will be identified. The CP dose administered will be 10mL/kg/dose (up to 2 units per dose) times two doses per patient for a total dose of 20 mL/kg. Patients will be followed for adverse events and clinical response. Research blood testing will be obtained prior to infusion (baseline) and serially weekly afterwards until clinical resolution. Patients will receive 2 doses equaling 20 mL/kg (if available) of ABO compatible CP over 24-48 hours if they do not experience grade 3-5 adverse events that are possible, probably, or definitely attributed to CP after the first dose. Patients will be followed for adverse events for a minimum of 28 days after the last infusion of CP.
If clinical status permits, administration of additional COVID-19 therapies should be delayed 48 hours or more from CP infusion completion. Supportive care will be administered by best clinical practice.
Number of grade 3-5 adverse events that are possible, probably or definitely related to the convalescent plasma (CP) infusion
Safety of convalescent plasma for pediatric patients will be determined by capturing the grade 3-5 adverse events that are possible, probably or definitely related to the CP infusion, defined using the NCI Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 28 days
Change in percent of supplemental oxygen
Change in percent of supplemental oxygen within 72 hours after infusion
Time frame: Baseline, 72 hours after infusion
Number of patients that required change in level of respiratory support
Number of patients that required change in level of respiratory support such as nasal canula, non-invasive ventilation, mechanical ventilation, high frequency oscillator ventilation, and extracorporeal membrane oxygenation (ECMO)
Time frame: Baseline, 72 hours after infusion
Mortality
Number of deaths
Time frame: up to 1 year
Mean length of ICU stay (days)
Length of ICU stay (days) will be recorded
Time frame: Up to 28 days
Mean length of hospital stay (days)
Length of hospital stay (days) will be recorded
Time frame: Up to 28 days
Mean length of ventilation (days)
Length of ventilation (days) will be recorded
Time frame: Up to 28 days
Number of patients with progression to renal dysfunction and/or multisystem organ failure
Number of patients with progression to renal dysfunction and/or multisystem organ failure will be recorded
Time frame: up to 1 year
IL-6 level
Cytokine milieu will be assayed by Luminex
Time frame: up to 28 days
Number of anti-SARS CoV 2 specific T cells
Cellular studies will be used for evaluation of anti-SARS CoV 2 specific T cells
Time frame: up to 28 days
Diversity of circulating T cells
Cellular studies will be used for evaluation of diversity of circulating T cells
Time frame: up to 28 days
ARS-CoV-2 Antibody Titer
Antibody titers to SARS-CoV-2 evaluation will be performed in vivo
Time frame: up to 28 days
SARS-CoV-2 Neutralizing Titer
Neutralizing antibodies are a type of virus specific antibody that not only bind virus but bind in a manner that prevents viral infection. Test will be will be performed in vivo.
Time frame: up to 28 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Emory University