SARS-CoV-2 InfectionPhase 1NCT04377672
Human Convalescent Plasma for High Risk Children Exposed or Infected With SARS-CoV-2 (COVID-19)
A Phase 1 study testing Anti-SARS-CoV-2 Human Convalescent Plasma in people with SARS-CoV-2 Infection, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of administration of plasma containing antibodies to the SARS-CoV-2 virus (i.e., convalescent plasma) and if it is able to prevent disease or lessen the severity of disease in individuals who are at high risk of developing COVID-19 due to a recent exposure. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- SARS-CoV-2 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
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2020to 13 Dec 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between 1 month and 18 years of age 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, Medically complex children defined as children who have a long-term dependence on technological support (including tracheotomy) associated with developmental delay and/or genetic anomalies21, Obesity, 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 168 hours after onset of symptoms (and within 192 hours at the time of receipt of 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 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 regions with widespread ongoing transmission] and a negative for SARS-CoV-2 (nasopharyngeal swab)
- Subject is judged by the investigator to have the initiative and means to be compliant with the protocol.
- Subjects or their legal representatives must have the ability to read, understand, and provide written informed consent for the initiation of any study related procedures.
Who cannot join
- History of severe reactions (e.g. anaphylaxis) to transfusion of blood products. Subjects 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.
- Inability to complete therapy with the study product within the stipulated time frame outlined above
- Female subjects in child-bearing age with a positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
- Subject / caregiver deemed by the study team to be non-compliant with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Pharmacokinetics of Human Convalescent Plasma in High Risk Children Exposed or Infected With SARS-CoV-2
The purpose of this study is to evaluate the safety of administration of plasma containing antibodies to the SARS-CoV-2 virus (i.e., convalescent plasma) and if it is able to prevent disease or lessen the severity of disease in individuals who are at high risk of developing COVID-19 due to a recent exposure. This study will also measure the level of anti-SARS-CoV-2 antibodies in patient's blood after the administration of the convalescent plasma.
Read the detailed description
People who become infected with a virus such as SARS-CoV-2 usually develop an immune response and produce antibodies against the virus. Antibodies are natural proteins made by the body's immune system that attack viruses and other germs. These antibodies are found in plasma, which is the yellow, clear part of the blood. There have been other studies using plasma to treat other types of viruses that showed some positive results. Human plasma containing antibodies to the SARS-CoV-2 virus is an option for prevention and treatment of COVID-19. This type of treatment, known as passive antibody therapy, could be rapidly available when there are sufficient numbers of people who have recovered from infection and can donate antibody-containing plasma. In contrast to vaccination strategies, which begin to provide protection weeks after administration, antibody-containing plasma would provide its protective benefits immediately. Additionally, passive antibody therapy may be the only way to provide immunity for some immunocompromised patients who do not respond to vaccines.
This research will evaluate the safety of administration of plasma containing antibodies to the SARS-CoV-2 virus (i.e., convalescent plasma). The research will also measure the level of anti-SARS-CoV-2 antibodies in patient's blood after the administration of the convalescent plasma.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- Anti-SARS-CoV-2 Human Convalescent Plasma
- Keywords
- convalescent, COVID-19, Coronavirus, plasma
- Medical subject headings
- COVID-19, 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
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.
| Study group | Role | What they receive |
|---|---|---|
| Anti- SARS-CoV-2 Plasma | Experimental | 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.
Safety of Treatment With High-titer Anti-SARS-CoV-2 Plasma as Assessed by Adverse Events
Number of subjects with grade 3 and 4 adverse events during the study period.
Measured: 28 days
Secondary outcomes (4)
Number of Subjects With Disease Worsening Event
Disease worsening as defined by hospitalization, need for supplemental oxygenation, respiratory distress, requirement for mechanical ventilation, and death.
Measured: 28 days
Pharmacokinetics of Anti-SARS-CoV-2 Antibodies as Defined by Changes in Antibody Titers
Anti-SARS-CoV-2 antibody titer changes. Recipient titers 30 minutes after plasma.
Measured: 30 minutes
Pharmacokinetics of Anti-SARS-CoV-2 Antibodies as Defined by Changes in Antibody Titers Over Time
Half lives based on totality of data
Measured: at 30 minutes, 7 days, 14 days, 21 days, 28 days after plasma administration.
Number of Subjects With a Natural Antibody Response to SARS-CoV-2 Infection
Presence or absence of endogenous anti-SARS-CoV-2 antibody titers.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start28 May 2020
- Primary completion1 Sep 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjay K Jain, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377672
- Sponsor's protocol ID
- IRB00247557
- Status last verified
- Mar 2024
- First submitted
- 4 May 2020
- Last updated
- 27 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jacquot C, Gordon O, Noland D, Donowitz JR, Levy E, Jain S, Willis Z, Rimland C, Loi M, Arrieta A, Annen K, Drapeau N, Osborne S, Ardura MI, Arora S, Zivick E, Delaney M. Multi-institutional experience with COVID-19 convalescent plasma in children. Transfusion. 2023 May;63(5):918-924. doi: 10.1111/trf.17318. Epub 2023 Mar 30.
PubMed 36965173Gordon O, Brosnan MK, Yoon S, Jung D, Littlefield K, Ganesan A, Caputo CA, Li M, Morgenlander WR, Henson SN, Ordonez AA, De Jesus P, Tucker EW, Peart Akindele N, Ma Z, Wilson J, Ruiz-Bedoya CA, Younger MEM, Bloch EM, Shoham S, Sullivan D, Tobian AA, Cooke KR, Larman B, Gobburu JV, Casadevall A, Pekosz A, Lederman HM, Klein SL, Jain SK. Pharmacokinetics of high-titer anti-SARS-CoV-2 human convalescent plasma in high-risk children. JCI Insight. 2022 Jan 25;7(2):e151518. doi: 10.1172/jci.insight.151518.
PubMed 34855624
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of Human Convalescent Plasma in High Risk Children Exposed or Infected With SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04377672
- Acronym / sponsor ID
- IRB00247557
- Conditions
- SARS-CoV-2 Infection
- Keywords
- convalescent, COVID-19, Coronavirus, plasma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 28 May 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Posted 27 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of administration of plasma containing antibodies to the SARS-CoV-2 virus (i.e., convalescent plasma) and if it is able to prevent disease or lessen the severity of disease in individuals who are at high risk of developing COVID-19 due to a recent exposure. This study will also measure the level of anti-SARS-CoV-2 antibodies in patient's blood after the administration of the convalescent plasma.
Detailed description
People who become infected with a virus such as SARS-CoV-2 usually develop an immune response and produce antibodies against the virus. Antibodies are natural proteins made by the body's immune system that attack viruses and other germs. These antibodies are found in plasma, which is the yellow, clear part of the blood. There have been other studies using plasma to treat other types of viruses that showed some positive results. Human plasma containing antibodies to the SARS-CoV-2 virus is an option for prevention and treatment of COVID-19. This type of treatment, known as passive antibody therapy, could be rapidly available when there are sufficient numbers of people who have recovered from infection and can donate antibody-containing plasma. In contrast to vaccination strategies, which begin to provide protection weeks after administration, antibody-containing plasma would provide its protective benefits immediately. Additionally, passive antibody therapy may be the only way to provide immunity for some immunocompromised patients who do not respond to vaccines.
This research will evaluate the safety of administration of plasma containing antibodies to the SARS-CoV-2 virus (i.e., convalescent plasma). The research will also measure the level of anti-SARS-CoV-2 antibodies in patient's blood after the administration of the convalescent plasma.
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 Plasma | Experimental | Biological: Anti-SARS-CoV-2 Human Convalescent PlasmaHuman Convalescent Plasma |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Between 1 month and 18 years of age 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, Medically complex children defined as children who have a long-term dependence on technological support (including tracheotomy) associated with developmental delay and/or genetic anomalies21, Obesity, Infant, i.e. child ≤1 year old.
- Confirmed SARS-CoV-2 infection OR high-risk exposure as defined:
- Subject is judged by the investigator to have the initiative and means to be compliant with the protocol.
- Subjects or their legal representatives must have the ability to read, understand, and provide written informed consent for the initiation of any study related procedures.
Key exclusion criteria (4 listed)
- History of severe reactions (e.g. anaphylaxis) to transfusion of blood products. Subjects 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.
- Inability to complete therapy with the study product within the stipulated time frame outlined above
- Female subjects in child-bearing age with a positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
- Subject / caregiver deemed by the study team to be non-compliant with the study 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 Plasma1-2 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. | Biological | Anti- SARS-CoV-2 Plasma |
Primary outcome
Safety of Treatment With High-titer Anti-SARS-CoV-2 Plasma as Assessed by Adverse Events
Time frame: 28 days
Number of subjects with grade 3 and 4 adverse events during the study period.
4 secondary outcomes
Number of Subjects With Disease Worsening Event
Time frame: 28 days
Pharmacokinetics of Anti-SARS-CoV-2 Antibodies as Defined by Changes in Antibody Titers
Time frame: 30 minutes
Pharmacokinetics of Anti-SARS-CoV-2 Antibodies as Defined by Changes in Antibody Titers Over Time
Time frame: at 30 minutes, 7 days, 14 days, 21 days, 28 days after plasma administration.
Number of Subjects With a Natural Antibody Response to SARS-CoV-2 Infection
Time frame: up to 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36965173Jacquot C, Gordon O, Noland D, Donowitz JR, Levy E, Jain S, Willis Z, Rimland C, Loi M, Arrieta A, Annen K, Drapeau N, Osborne S, Ardura MI, Arora S, Zivick E, Delaney M. Multi-institutional experience with COVID-19 convalescent plasma in children. Transfusion. 2023 May;63(5):918-924. doi: 10.1111/trf.17318. Epub 2023 Mar 30.
- Derived from this study: PubMed 34855624Gordon O, Brosnan MK, Yoon S, Jung D, Littlefield K, Ganesan A, Caputo CA, Li M, Morgenlander WR, Henson SN, Ordonez AA, De Jesus P, Tucker EW, Peart Akindele N, Ma Z, Wilson J, Ruiz-Bedoya CA, Younger MEM, Bloch EM, Shoham S, Sullivan D, Tobian AA, Cooke KR, Larman B, Gobburu JV, Casadevall A, Pekosz A, Lederman HM, Klein SL, Jain SK. Pharmacokinetics of high-titer anti-SARS-CoV-2 human convalescent plasma in high-risk children. JCI Insight. 2022 Jan 25;7(2):e151518. doi: 10.1172/jci.insight.151518.
- 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.
Sanjay K Jain, MD principal investigator
Johns Hopkins University
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 SARS-CoV-2 Infection, run by Johns Hopkins 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 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: finished, as of the sponsor's last update on 27 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 27 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety of Treatment With High-titer Anti-SARS-CoV-2 Plasma as Assessed by Adverse Events (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04377672, which also lists 2 linked publications.
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 27 Mar 2024.