Trial Outcomes & Findings for Human Convalescent Plasma for High Risk Children Exposed or Infected With SARS-CoV-2 (COVID-19) (NCT NCT04377672)
NCT ID: NCT04377672
Last Updated: 2024-03-27
Results Overview
Number of subjects with grade 3 and 4 adverse events during the study period.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
28 days
Results posted on
2024-03-27
Participant Flow
Participant milestones
| Measure |
Anti- SARS-CoV-2 Plasma
Human Convalescent Plasma
Anti-SARS-CoV-2 Human Convalescent Plasma: 1-2 unit (200-250 mL per unit) of plasma with anti-SARS-CoV-19 titers of ≥1:320.
The total volume (mL) infused will be based on weight (5 mL/kg) with a maximum volume of 500 mL.
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|---|---|
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Overall Study
STARTED
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14
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Anti- SARS-CoV-2 Plasma
Human Convalescent Plasma
Anti-SARS-CoV-2 Human Convalescent Plasma: 1-2 unit (200-250 mL per unit) of plasma with anti-SARS-CoV-19 titers of ≥1:320.
The total volume (mL) infused will be based on weight (5 mL/kg) with a maximum volume of 500 mL.
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|---|---|
|
Overall Study
Participants was withdrawn from study due to false positive COVID-19 test
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1
|
Baseline Characteristics
Human Convalescent Plasma for High Risk Children Exposed or Infected With SARS-CoV-2 (COVID-19)
Baseline characteristics by cohort
| Measure |
Anti- SARS-CoV-2 Plasma
n=14 Participants
Human Convalescent Plasma
Anti-SARS-CoV-2 Human Convalescent Plasma: 1-2 unit (200-250 mL per unit) of plasma with anti-SARS-CoV-19 titers of ≥1:320.
The total volume (mL) infused will be based on weight (5 mL/kg) with a maximum volume of 500 mL.
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|---|---|
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Age, Continuous
|
7.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
|
Previous diagnosis
DICER1-associated parietal lobe sarcoma
|
1 Participants
n=5 Participants
|
|
Previous diagnosis
Prematurity, acyanotic Tetralogy of Fallot, chronic lung disease
|
1 Participants
n=5 Participants
|
|
Previous diagnosis
Immunodeficiency with CARD11 mutation and IVIG dependent
|
1 Participants
n=5 Participants
|
|
Previous diagnosis
Crohn's disease, receiving infliximab
|
1 Participants
n=5 Participants
|
|
Previous diagnosis
Asthma
|
1 Participants
n=5 Participants
|
|
Previous diagnosis
Chromosome 18q deletion, CVID, IVIG dependent, chronic lung disease
|
1 Participants
n=5 Participants
|
|
Previous diagnosis
SMA type 1
|
1 Participants
n=5 Participants
|
|
Previous diagnosis
S/P Wilms tumor and BMT asthma
|
1 Participants
n=5 Participants
|
|
Previous diagnosis
Prematurity, chronic lung disease, CVID, IVIG dependent
|
1 Participants
n=5 Participants
|
|
Previous diagnosis
Ataxia telangiectasia, IVIG dependent
|
1 Participants
n=5 Participants
|
|
Previous diagnosis
Cerebral palsy, epilepsy, chronic lung disease
|
1 Participants
n=5 Participants
|
|
Previous diagnosis
Caroli syndrome, ARPKD, liver and kidney transplant, tracheostomy
|
1 Participants
n=5 Participants
|
|
Previous diagnosis
Ataxia Telangiectasia, chronic lung disease
|
1 Participants
n=5 Participants
|
|
Previous diagnosis
Liver failure
|
1 Participants
n=5 Participants
|
|
COVID-19 Signs & Symptoms
Fever
|
8 Participants
n=5 Participants
|
|
COVID-19 Signs & Symptoms
Cough
|
5 Participants
n=5 Participants
|
|
COVID-19 Signs & Symptoms
Congestion
|
2 Participants
n=5 Participants
|
|
COVID-19 Signs & Symptoms
Muscle Aches
|
1 Participants
n=5 Participants
|
|
COVID-19 Signs & Symptoms
Tachypnea
|
1 Participants
n=5 Participants
|
|
COVID-19 Signs & Symptoms
Asymptomatic
|
3 Participants
n=5 Participants
|
|
COVID-19 Signs & Symptoms
Sore throat
|
2 Participants
n=5 Participants
|
|
COVID-19 Signs & Symptoms
Respiratory failure requiring noninvasive ventilation
|
3 Participants
n=5 Participants
|
|
COVID-19 Signs & Symptoms
Desaturation
|
1 Participants
n=5 Participants
|
|
COVID-19 Signs & Symptoms
Headache
|
1 Participants
n=5 Participants
|
|
SARS CoV-2 PCR
Positive SARS CoV-2 PCR
|
8 Participants
n=5 Participants
|
|
SARS CoV-2 PCR
Negative SARS CoV-2 PCR
|
5 Participants
n=5 Participants
|
|
SARS CoV-2 PCR
False Positive SARS CoV-2 PCR
|
1 Participants
n=5 Participants
|
|
Hospital Admission
Yes
|
6 Participants
n=5 Participants
|
|
Hospital Admission
No
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysNumber of subjects with grade 3 and 4 adverse events during the study period.
Outcome measures
| Measure |
Anti- SARS-CoV-2 Plasma
n=13 Participants
Human Convalescent Plasma
Anti-SARS-CoV-2 Human Convalescent Plasma: 1-2 unit (200-250 mL per unit) of plasma with anti-SARS-CoV-19 titers of ≥1:320.
The total volume (mL) infused will be based on weight (5 mL/kg) with a maximum volume of 500 mL.
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|---|---|
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Safety of Treatment With High-titer Anti-SARS-CoV-2 Plasma as Assessed by Adverse Events
|
0 Participants
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SECONDARY outcome
Timeframe: 28 daysDisease worsening as defined by hospitalization, need for supplemental oxygenation, respiratory distress, requirement for mechanical ventilation, and death.
Outcome measures
| Measure |
Anti- SARS-CoV-2 Plasma
n=13 Participants
Human Convalescent Plasma
Anti-SARS-CoV-2 Human Convalescent Plasma: 1-2 unit (200-250 mL per unit) of plasma with anti-SARS-CoV-19 titers of ≥1:320.
The total volume (mL) infused will be based on weight (5 mL/kg) with a maximum volume of 500 mL.
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|---|---|
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Number of Subjects With Disease Worsening Event
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0 Participants
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SECONDARY outcome
Timeframe: 30 minutesPopulation: Recipient titers 30 minutes after plasma administration was available for 9 participants.
Anti-SARS-CoV-2 antibody titer changes. Recipient titers 30 minutes after plasma.
Outcome measures
| Measure |
Anti- SARS-CoV-2 Plasma
n=9 Participants
Human Convalescent Plasma
Anti-SARS-CoV-2 Human Convalescent Plasma: 1-2 unit (200-250 mL per unit) of plasma with anti-SARS-CoV-19 titers of ≥1:320.
The total volume (mL) infused will be based on weight (5 mL/kg) with a maximum volume of 500 mL.
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|---|---|
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Pharmacokinetics of Anti-SARS-CoV-2 Antibodies as Defined by Changes in Antibody Titers
|
5.6 percent of donor titer
Interval 1.2 to 7.5
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SECONDARY outcome
Timeframe: at 30 minutes, 7 days, 14 days, 21 days, 28 days after plasma administration.Population: Calculation of antibody half-lives (T1/2) was available for 7 participants.
Half lives based on totality of data
Outcome measures
| Measure |
Anti- SARS-CoV-2 Plasma
n=7 Participants
Human Convalescent Plasma
Anti-SARS-CoV-2 Human Convalescent Plasma: 1-2 unit (200-250 mL per unit) of plasma with anti-SARS-CoV-19 titers of ≥1:320.
The total volume (mL) infused will be based on weight (5 mL/kg) with a maximum volume of 500 mL.
|
|---|---|
|
Pharmacokinetics of Anti-SARS-CoV-2 Antibodies as Defined by Changes in Antibody Titers Over Time
|
15.1 Antibody half lives (days)
Interval 7.3 to 22.9
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SECONDARY outcome
Timeframe: up to 2 monthsPopulation: SARS-CoV-2-infected participants who demonstrated presence of endogenous antibody production
Presence or absence of endogenous anti-SARS-CoV-2 antibody titers.
Outcome measures
| Measure |
Anti- SARS-CoV-2 Plasma
n=9 Participants
Human Convalescent Plasma
Anti-SARS-CoV-2 Human Convalescent Plasma: 1-2 unit (200-250 mL per unit) of plasma with anti-SARS-CoV-19 titers of ≥1:320.
The total volume (mL) infused will be based on weight (5 mL/kg) with a maximum volume of 500 mL.
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|---|---|
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Number of Subjects With a Natural Antibody Response to SARS-CoV-2 Infection
|
7 Participants
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Adverse Events
Anti- SARS-CoV-2 Plasma
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Anti- SARS-CoV-2 Plasma
n=13 participants at risk
Human Convalescent Plasma
Anti-SARS-CoV-2 Human Convalescent Plasma: 1-2 unit (200-250 mL per unit) of plasma with anti-SARS-CoV-19 titers of ≥1:320.
The total volume (mL) infused will be based on weight (5 mL/kg) with a maximum volume of 500 mL.
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|---|---|
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Immune system disorders
Rash
|
23.1%
3/13 • Number of events 3 • 120 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place