Covid-19 Convalescent Plasma as Prevention and Treatment... | NCT04462848

NCT04462848

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
anti-SARS-CoV-2 human convalescent plasma	Experimental	single transfusion of human convalescent plasma	Biological: anti-SARS-CoV-2 human convalescent plasma

Interventions

Name	Type	Description	Arm Group Labels	Other Names
anti-SARS-CoV-2 human convalescent plasma	Biological	Single transfusion. The total volume (mL) to be transfused will be based on participant weight (kg) and will be calculated as 5 mL/kg. The maximum volume to be transfused will be 500 mL.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cumulative incidence of Grade 3 and Grade 4 adverse events	A Grade 3 adverse event is any untoward or unfavorable medical occurrence in which symptoms are severe and cause inability to perform usual social and functional activities with medical intervention or therapy indicated. A Grade 4 adverse event is any untoward or unfavorable medical occurrence in which potentially life-threatening symptoms cause inability to perform basic self-care functions with medical intervention or therapy indicated to prevent permanent impairment, persistent disability, or death.	up to Day 28 post-administration of study plasma
Cumulative incidence of serious adverse events	A serious adverse event is any untoward or unfavorable medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect, or is an important medical event that may or may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.	up to Day 28 post-administration of study plasma

Secondary Outcomes

Measure	Description	Time Frame
Proportion of participants with disease worsening event.	Descriptive analysis of disease worsening event as represented by hospitalization, prolongation of hospitalization, need for supplemental oxygen, respiratory distress, requirement for mechanical ventilation, and death.	up to Day 28 post-administration of study plasma

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 1 month and < 18 years at the time of consent.
Determined to be at high-risk for severe SARS-CoV-2 disease based on the American Academy of Pediatrics definition of immunocompromised children and reported high-risk pediatric subpopulations. These include the following groups: immunocompromised, hemodynamically significant cardiac disease (e.g. congenital heart disease), lung disease with chronic respiratory failure, infant, i.e. child ≤1 year old.
Confirmed SARS-CoV-2 infection OR high-risk exposure as defined:
- Confirmed infection: Child who tested positive for COVID-19 and is no more than 96 hours after onset of symptoms (and within 120 hours at the time of receipt of study plasma).
- High-risk exposure: Susceptible child who was not previously infected or otherwise immune to SARS-CoV-2 and exposed within 96 hours prior to enrollment (and within 120 hours at the time of receipt of study plasma). Both criteria below should be met:
  1. A household member or daycare center (same room) exposure to a person with confirmed SARS-CoV-2 OR with clinically compatible disease in areas with widespread ongoing transmission
  2. Negative for SARS-CoV-2 (nasopharyngeal or oropharyngeal swab)
For females of reproductive potential (defined as having experienced menarche), not pregnant based on testing performed at screening.
Parent or legal guardian able and willing to provide signed parent permission.

Exclusion Criteria:

History of severe reactions (e.g. anaphylaxis) to transfusion of blood products. Individuals with minor reactions such as fever, itching, chills, etc. that resolve spontaneously or respond to pre-medications, and that do not represent more significant allergic reactions, will not be excluded.
For females, breastfeeding, or planning to become pregnant/breastfeed during the study period.
Participant is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate outside the greater Los Angeles area during the study.
Any condition that would, in the opinion of the principal investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol.