COVIDEarly Phase 1NCT04458363
Convalescent Plasma in Pediatric COVID-19
A Early Phase 1 study testing Convalescent Plasma (CP) and Standard COVID-19 therapies in people with COVID, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 22 years
- Conditions the study is for
- COVID
- What is being tested?
- Convalescent Plasma (CP) and Standard COVID-19 therapies
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jul 2020to 1 Sep 2020
- Phase
- Early 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 0 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 0 to 22 years of age
- SARS-CoV-2 infection documented by RNA RT-PCR detection
- Admitted to an acute care facility
- Ability of patient or guardian to provide consent and assent (if applicable); if patient is intubated assent may be waived
- Severe COVID-19 disease, OR
- Moderate disease with a risk of progression to severe or life threatening disease, OR
- Severely immunocompromised patient with any illness attributed to COVID-19 disease requiring inpatient care.
Who cannot join
- Pregnancy/ breast feeding
- Medical condition that increases the risk of plasma infusion
- Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
- Pregnancy/ breast feeding
- Medical condition that increases the risk of plasma infusion
- Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: Convalescent Plasma to Optimize Treatment of COVID-19 Disease in Pediatric Patients: A Feasibility Study
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.
Read the detailed description
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.
- Conditions
- COVID
- Being tested
- Convalescent Plasma (CP), Standard COVID-19 therapies
- Keywords
- COVID-19, Pediatric, Convalescent Plasma, Safety
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent Plasma (CP)Biological
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.
Standard COVID-19 therapiesDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Convalescent Plasma (CP) | Experimental | 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 Receives: Biological: Convalescent Plasma (CP); Drug: Standard COVID-19 therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 28 days
Secondary outcomes (12)
Change in percent of supplemental oxygen
Change in percent of supplemental oxygen within 72 hours after infusion
Measured: 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)
Measured: Baseline, 72 hours after infusion
Mortality
Number of deaths
Measured: up to 1 year
Mean length of ICU stay (days)
Length of ICU stay (days) will be recorded
Measured: Up to 28 days
Mean length of hospital stay (days)
Length of hospital stay (days) will be recorded
Measured: Up to 28 days
Mean length of ventilation (days)
Length of ventilation (days) will be recorded
Measured: 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
Measured: up to 1 year
IL-6 level
Cytokine milieu will be assayed by Luminex
Measured: 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
Measured: up to 28 days
Diversity of circulating T cells
Cellular studies will be used for evaluation of diversity of circulating T cells
Measured: up to 28 days
ARS-CoV-2 Antibody Titer
Antibody titers to SARS-CoV-2 evaluation will be performed in vivo
Measured: 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.
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start4 Jul 2020
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Preeti Jaggi, Emory University
- Investigators
- Preeti Jaggi, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458363
- Sponsor's protocol ID
- STUDY00000789
- Status last verified
- Nov 2021
- First submitted
- 25 Jun 2020
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convalescent Plasma to Optimize Treatment of COVID-19 Disease in Pediatric Patients: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04458363
- Acronym / sponsor ID
- STUDY00000789
- Conditions
- COVID
- Keywords
- COVID-19, Pediatric, Convalescent Plasma, Safety
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 4 Jul 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 7 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Convalescent Plasma (CP) | Experimental | Biological: Convalescent Plasma (CP), Drug: Standard COVID-19 therapiesOnce the patient meets criteria for CP infusion (severity of disease and risk factor determination and absence of exclusion criteria) convalescent plasma will be administered |
Who may qualify
- Ages
- 0 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Aged 0 to 22 years of age
- SARS-CoV-2 infection documented by RNA RT-PCR detection
- Admitted to an acute care facility
- Ability of patient or guardian to provide consent and assent (if applicable); if patient is intubated assent may be waived
- Severe COVID-19 disease, OR
Key exclusion criteria (6 listed)
- Pregnancy/ breast feeding
- Medical condition that increases the risk of plasma infusion
- Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
- Pregnancy/ breast feeding
- Medical condition that increases the risk of plasma infusion
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 |
|---|---|---|
| Convalescent Plasma (CP)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. | Biological | Convalescent Plasma (CP) |
| Standard COVID-19 therapiesIf 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. | Drug | Convalescent Plasma (CP) |
Primary outcome
Number of grade 3-5 adverse events that are possible, probably or definitely related to the convalescent plasma (CP) infusion
Time frame: 28 days
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)
12 secondary outcomes
Change in percent of supplemental oxygen
Time frame: Baseline, 72 hours after infusion
Number of patients that required change in level of respiratory support
Time frame: Baseline, 72 hours after infusion
Mortality
Time frame: up to 1 year
Mean length of ICU stay (days)
Time frame: Up to 28 days
Mean length of hospital stay (days)
Time frame: Up to 28 days
Mean length of ventilation (days)
Time frame: Up to 28 days
Number of patients with progression to renal dysfunction and/or multisystem organ failure
Time frame: up to 1 year
IL-6 level
Time frame: up to 28 days
Number of anti-SARS CoV 2 specific T cells
Time frame: up to 28 days
Diversity of circulating T cells
Time frame: up to 28 days
ARS-CoV-2 Antibody Titer
Time frame: up to 28 days
SARS-CoV-2 Neutralizing Titer
Time frame: up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for COVID
RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
Active, not recruitingPhase 2
COVID-FISETIN: Pilot in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Inflammation
Covid19
RecruitingObservational study
Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
Post-Coronavirus Disease 19
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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.
Preeti Jaggi, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Convalescent Plasma (CP) and Standard COVID-19 therapies in people with COVID, run by Emory University 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 22 Nov 2021. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of grade 3-5 adverse events that are possible, probably or definitely related to the convalescent plasma (CP) infusion (time frame: 28 days). 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 22 Nov 2021.