Corona Virus InfectionPhase 1NCT04462848
Covid-19 Convalescent Plasma as Prevention and Treatment for Children With Underlying Medical Conditions
A Phase 1 study testing anti-SARS-CoV-2 human convalescent plasma in people with Corona Virus Infection, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will provide access to investigational anti-SARS-CoV-2 human convalescent plasma for pediatric patients with underlying medical conditions (cardiovascular disease, lung disease, immunosuppression) who are either infected with SARS-CoV-2 or who have had a high-risk exposure. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- anti-SARS-CoV-2 human convalescent plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2020to Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles (UCLA)
Los Angeles, California, 90095
Jaime G Deville, M.D., 310-825-9660, jdeville@mednet.ucla.edu
Michele F Carter, R.N., 310-206-6369, mfcarter@mednet.ucla.edu
About this study
Official title: Phase I Study of the Safety and Pharmacokinetics of Human Convalescent Plasma in High Risk Children Exposed or Infected With SARS-CoV-2
This study will provide access to investigational anti-SARS-CoV-2 human convalescent plasma for pediatric patients with underlying medical conditions (cardiovascular disease, lung disease, immunosuppression) who are either infected with SARS-CoV-2 or who have had a high-risk exposure. Study participants will be transfused once with compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2. Safety information and pharmacokinetic data will be collected.
- Conditions
- Corona Virus Infection
- Being tested
- anti-SARS-CoV-2 human convalescent plasma
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-SARS-CoV-2 human convalescent plasmaBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| anti-SARS-CoV-2 human convalescent plasma | Experimental | single transfusion of human convalescent plasma Receives: Biological: anti-SARS-CoV-2 human convalescent plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to Day 28 post-administration of study plasma
Secondary outcomes (3)
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.
Measured: up to Day 28 post-administration of study plasma
Serum concentration at baseline, Day 7, Day 14, and Day 28 for anti-SARS-CoV-2 antibodies
Anti-SARS-CoV-2 antibody titer changes over time
Measured: Days 0, 7, 14, and 28
Percentage of participants with a natural antibody response to SARS-CoV-2 infection
This will be assessed by the presence or absence of anti-SARS-CoV-2 antibody titers to be collected once between 60 and 120 days post study plasma administration
Measured: once between Day 60 and Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study startAug 2020 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime G. Deville, MD, FAAP, University of California, Los Angeles
- Investigators
- Jaime G Deville, M.D., Principal investigator, UCLA Clinical Professor of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462848
- Sponsor's protocol ID
- IRB#20-001263
- Status last verified
- Jul 2020
- First submitted
- 30 Jun 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Safety and Pharmacokinetics of Human Convalescent Plasma in High Risk Children Exposed or Infected With SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04462848
- Acronym / sponsor ID
- IRB#20-001263
- Conditions
- Corona Virus Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will provide access to investigational anti-SARS-CoV-2 human convalescent plasma for pediatric patients with underlying medical conditions (cardiovascular disease, lung disease, immunosuppression) who are either infected with SARS-CoV-2 or who have had a high-risk exposure. Study participants will be transfused once with compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2. Safety information and pharmacokinetic data will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-SARS-CoV-2 human convalescent plasma | Experimental | Biological: anti-SARS-CoV-2 human convalescent plasmasingle transfusion of human convalescent plasma |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-SARS-CoV-2 human convalescent plasmaSingle 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. | Biological | anti-SARS-CoV-2 human convalescent plasma |
Primary outcome
Cumulative incidence of Grade 3 and Grade 4 adverse events
Time frame: up to Day 28 post-administration of study plasma
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.
Cumulative incidence of serious adverse events
Time frame: up to Day 28 post-administration of study plasma
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.
3 secondary outcomes
Proportion of participants with disease worsening event.
Time frame: up to Day 28 post-administration of study plasma
Serum concentration at baseline, Day 7, Day 14, and Day 28 for anti-SARS-CoV-2 antibodies
Time frame: Days 0, 7, 14, and 28
Percentage of participants with a natural antibody response to SARS-CoV-2 infection
Time frame: once between Day 60 and Day 120
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime G Deville, M.D. principal investigator
UCLA Clinical Professor of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing anti-SARS-CoV-2 human convalescent plasma in people with Corona Virus Infection, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaime G Deville, M.D. (310-825-9660, jdeville@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of Grade 3 and Grade 4 adverse events (time frame: up to Day 28 post-administration of study plasma). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.