COVID-19RECONNNCT04838834
Monitoring Serologic Response to Severe Acute Respiratory Syndrome-2 (SARS-COV-2)/COVID-19 in Children
An observational study of COVID-19 and SARS-CoV-2, run by Connecticut Children's Medical Center at 1 site in United States.
Trial summary
Individuals susceptible to SARS-CoV-2 and the illness it causes (COVID-19) are comprised of heterogeneous populations with a large risk spectrum for more severe disease. Pre-existing risk factors for a more severe course include respiratory and cardiovascular disease, morbid obesity, diabetes, underlying kidney or… Read more about this study
- Who is it for?
- Ages 2 to 27 years
- Conditions the study is for
- COVID-19, SARS-CoV-2, Inflammatory Bowel Diseases
- How many people
- 472 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2020to 10 Feb 2025
- Phase
- Observational
- 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 2 to 27 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and young adults with inflammatory bowel disease or juvenile idiopathic arthritis receiving treatment with biologic agents at Connecticut Children's Infusion Center
Who may be able to join
- Patients aged 2 to 27 years inclusive
- Patients receiving biologic infusions for inflammatory or rheumatologic disorders at the Connecticut Children's Infusion Center, at a minimum frequency of 2 infusions over a 4 month period
- Consent/assent as indicated
- Have vein access placement as standard of care
Who cannot join
- Patient and/or parent/legal guardian refused participation
- Inability to draw requisite blood sample for serum collection
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
About this study
Official title: Monitoring Serologic Response to SARS-COV-2 / Coronavirus Disease 2019 (COVID-19) in Children, Adolescents, and Young Adults Receiving Biologic Therapies (RECONN)
Individuals susceptible to SARS-CoV-2 and the illness it causes (COVID-19) are comprised of heterogeneous populations with a large risk spectrum for more severe disease. Pre-existing risk factors for a more severe course include respiratory and cardiovascular disease, morbid obesity, diabetes, underlying kidney or liver disease, and immunocompromised status. Whether children and young adults with inflammatory bowel disease (IBD) or juvenile idiopathic arthritis (JIA) receiving immunomodulating biologic and other therapies which are known to increase risk of viral infection are at increased risk of complications from COVID-19 or post-infectious co-morbidities, including the recently described multi inflammatory syndrome (MISC), is entirely unclear. This research focuses on the heretofore uncharacterized immune response to SARS-CoV-2 infection in children and young adults with IBD or JIA who are receiving maintenance immunosuppressive biologic therapies. Given the large Connecticut based infusion program, in a region of the United States with a recent large outbreak of COVID-19, the investigators have a unique opportunity to address a glaring knowledge gap in this unique pediatric, adolescent, and young adult population. The investigators will longitudinally determine antibody development and durability to SARS-CoV-2 in approximately 450-500 children and young adults with IBD or JIA receiving biologic therapy using a highly sensitive and specific quantitative assay utilizing novel technology. This period will include a return to school or work for many with likely resurgent infections, as well as the possible introduction of anti-SARS CoV-2 vaccines. The specific aim is to study the acute and convalescent antibody responses to SARS-CoV-2 infection in a cohort of children and young adults receiving infusions of biologic therapies for IBD and JIA.
- Conditions
- COVID-19, SARS-CoV-2, Inflammatory Bowel Diseases
- Keywords
- COVID-19 Serological Testing
- Medical subject headings
- COVID-19, Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of anti-SARS-CoV-2 Immunoglobulin G (IgG)
Measured: At the time of infusions for up to 2 years
Secondary outcomes (1)
Presence of anti-SARS-CoV-2 IgG neutralizing antibodies
Measured: At the time of infusions for up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start15 May 2020
- Primary completion10 Feb 2025
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Jackson Laboratory, Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Hyams, MD, Principal investigator, Connecticut Children's Medical Ctr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838834
- Sponsor's protocol ID
- 20-073
- Acronym
- RECONN
- Status last verified
- Mar 2025
- First submitted
- 11 Feb 2021
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Neurath MF. COVID-19 and immunomodulation in IBD. Gut. 2020 Jul;69(7):1335-1342. doi: 10.1136/gutjnl-2020-321269. Epub 2020 Apr 17.
PubMed 32303609Brenner EJ, Ungaro RC, Gearry RB, Kaplan GG, Kissous-Hunt M, Lewis JD, Ng SC, Rahier JF, Reinisch W, Ruemmele FM, Steinwurz F, Underwood FE, Zhang X, Colombel JF, Kappelman MD. Corticosteroids, But Not TNF Antagonists, Are Associated With Adverse COVID-19 Outcomes in Patients With Inflammatory Bowel Diseases: Results From an International Registry. Gastroenterology. 2020 Aug;159(2):481-491.e3. doi: 10.1053/j.gastro.2020.05.032. Epub 2020 May 18.
PubMed 32425234Brenner EJ, Pigneur B, Focht G, Zhang X, Ungaro RC, Colombel JF, Turner D, Kappelman MD, Ruemmele FM. Benign Evolution of SARS-Cov2 Infections in Children With Inflammatory Bowel Disease: Results From Two International Databases. Clin Gastroenterol Hepatol. 2021 Feb;19(2):394-396.e5. doi: 10.1016/j.cgh.2020.10.010. Epub 2020 Oct 12.
PubMed 33059040Robbiani DF, Gaebler C, Muecksch F, Lorenzi JCC, Wang Z, Cho A, Agudelo M, Barnes CO, Gazumyan A, Finkin S, Hagglof T, Oliveira TY, Viant C, Hurley A, Hoffmann HH, Millard KG, Kost RG, Cipolla M, Gordon K, Bianchini F, Chen ST, Ramos V, Patel R, Dizon J, Shimeliovich I, Mendoza P, Hartweger H, Nogueira L, Pack M, Horowitz J, Schmidt F, Weisblum Y, Michailidis E, Ashbrook AW, Waltari E, Pak JE, Huey-Tubman KE, Koranda N, Hoffman PR, West AP Jr, Rice CM, Hatziioannou T, Bjorkman PJ, Bieniasz PD, Caskey M, Nussenzweig MC. Convergent antibody responses to SARS-CoV-2 in convalescent individuals. Nature. 2020 Aug;584(7821):437-442. doi: 10.1038/s41586-020-2456-9. Epub 2020 Jun 18.
PubMed 32555388Gaebler C, Wang Z, Lorenzi JCC, Muecksch F, Finkin S, Tokuyama M, Cho A, Jankovic M, Schaefer-Babajew D, Oliveira TY, Cipolla M, Viant C, Barnes CO, Hurley A, Turroja M, Gordon K, Millard KG, Ramos V, Schmidt F, Weisblum Y, Jha D, Tankelevich M, Yee J, Shimeliovich I, Robbiani DF, Zhao Z, Gazumyan A, Hatziioannou T, Bjorkman PJ, Mehandru S, Bieniasz PD, Caskey M, Nussenzweig MC, Hagglof T, Schwartz RE, Bram Y, Martinez-Delgado G, Mendoza P, Breton G, Dizon J, Unson-O'Brien C, Patel R. Evolution of Antibody Immunity to SARS-CoV-2. bioRxiv [Preprint]. 2021 Jan 4:2020.11.03.367391. doi: 10.1101/2020.11.03.367391.
PubMed 33173867Dittadi R, Afshar H, Carraro P. The early antibody response to SARS-Cov-2 infection. Clin Chem Lab Med. 2020 Sep 25;58(10):e201-e203. doi: 10.1515/cclm-2020-0617. No abstract available.
PubMed 32639941
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Serologic Response to SARS-COV-2 / Coronavirus Disease 2019 (COVID-19) in Children, Adolescents, and Young Adults Receiving Biologic Therapies (RECONN)
- ClinicalTrials.gov ID
- NCT04838834
- Acronym / sponsor ID
- RECONN / 20-073
- Conditions
- COVID-19, SARS-CoV-2, Inflammatory Bowel Diseases
- Keywords
- COVID-19 Serological Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Collaborators
- The Jackson Laboratory, Food and Drug Administration (FDA)
- Study start
- 15 May 2020 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 9 Apr 2021 (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.
Individuals susceptible to SARS-CoV-2 and the illness it causes (COVID-19) are comprised of heterogeneous populations with a large risk spectrum for more severe disease. Pre-existing risk factors for a more severe course include respiratory and cardiovascular disease, morbid obesity, diabetes, underlying kidney or liver disease, and immunocompromised status. Whether children and young adults with inflammatory bowel disease (IBD) or juvenile idiopathic arthritis (JIA) receiving immunomodulating biologic and other therapies which are known to increase risk of viral infection are at increased risk of complications from COVID-19 or post-infectious co-morbidities, including the recently described multi inflammatory syndrome (MISC), is entirely unclear. This research focuses on the heretofore uncharacterized immune response to SARS-CoV-2 infection in children and young adults with IBD or JIA who are receiving maintenance immunosuppressive biologic therapies. Given the large Connecticut based infusion program, in a region of the United States with a recent large outbreak of COVID-19, the investigators have a unique opportunity to address a glaring knowledge gap in this unique pediatric, adolescent, and young adult population. The investigators will longitudinally determine antibody development and durability to SARS-CoV-2 in approximately 450-500 children and young adults with IBD or JIA receiving biologic therapy using a highly sensitive and specific quantitative assay utilizing novel technology. This period will include a return to school or work for many with likely resurgent infections, as well as the possible introduction of anti-SARS CoV-2 vaccines. The specific aim is to study the acute and convalescent antibody responses to SARS-CoV-2 infection in a cohort of children and young adults receiving infusions of biologic therapies for IBD and JIA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and young adults with inflammatory bowel disease or juvenile idiopathic arthritis receiving treatment with biologic agents at Connecticut Children's Infusion Center
Key inclusion criteria (4 listed)
- Patients aged 2 to 27 years inclusive
- Patients receiving biologic infusions for inflammatory or rheumatologic disorders at the Connecticut Children's Infusion Center, at a minimum frequency of 2 infusions over a 4 month period
- Consent/assent as indicated
- Have vein access placement as standard of care
Key exclusion criteria (2 listed)
- Patient and/or parent/legal guardian refused participation
- Inability to draw requisite blood sample for serum collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of anti-SARS-CoV-2 Immunoglobulin G (IgG)
Time frame: At the time of infusions for up to 2 years
1 secondary outcome
Presence of anti-SARS-CoV-2 IgG neutralizing antibodies
Time frame: At the time of infusions for up to 2 years
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 1 Apr 2025.
- Background: PubMed 32303609Neurath MF. COVID-19 and immunomodulation in IBD. Gut. 2020 Jul;69(7):1335-1342. doi: 10.1136/gutjnl-2020-321269. Epub 2020 Apr 17.
- Background: PubMed 32425234Brenner EJ, Ungaro RC, Gearry RB, Kaplan GG, Kissous-Hunt M, Lewis JD, Ng SC, Rahier JF, Reinisch W, Ruemmele FM, Steinwurz F, Underwood FE, Zhang X, Colombel JF, Kappelman MD. Corticosteroids, But Not TNF Antagonists, Are Associated With Adverse COVID-19 Outcomes in Patients With Inflammatory Bowel Diseases: Results From an International Registry. Gastroenterology. 2020 Aug;159(2):481-491.e3. doi: 10.1053/j.gastro.2020.05.032. Epub 2020 May 18.
- Background: PubMed 33059040Brenner EJ, Pigneur B, Focht G, Zhang X, Ungaro RC, Colombel JF, Turner D, Kappelman MD, Ruemmele FM. Benign Evolution of SARS-Cov2 Infections in Children With Inflammatory Bowel Disease: Results From Two International Databases. Clin Gastroenterol Hepatol. 2021 Feb;19(2):394-396.e5. doi: 10.1016/j.cgh.2020.10.010. Epub 2020 Oct 12.
- Background: PubMed 32555388Robbiani DF, Gaebler C, Muecksch F, Lorenzi JCC, Wang Z, Cho A, Agudelo M, Barnes CO, Gazumyan A, Finkin S, Hagglof T, Oliveira TY, Viant C, Hurley A, Hoffmann HH, Millard KG, Kost RG, Cipolla M, Gordon K, Bianchini F, Chen ST, Ramos V, Patel R, Dizon J, Shimeliovich I, Mendoza P, Hartweger H, Nogueira L, Pack M, Horowitz J, Schmidt F, Weisblum Y, Michailidis E, Ashbrook AW, Waltari E, Pak JE, Huey-Tubman KE, Koranda N, Hoffman PR, West AP Jr, Rice CM, Hatziioannou T, Bjorkman PJ, Bieniasz PD, Caskey M, Nussenzweig MC. Convergent antibody responses to SARS-CoV-2 in convalescent individuals. Nature. 2020 Aug;584(7821):437-442. doi: 10.1038/s41586-020-2456-9. Epub 2020 Jun 18.
- Background: PubMed 33173867Gaebler C, Wang Z, Lorenzi JCC, Muecksch F, Finkin S, Tokuyama M, Cho A, Jankovic M, Schaefer-Babajew D, Oliveira TY, Cipolla M, Viant C, Barnes CO, Hurley A, Turroja M, Gordon K, Millard KG, Ramos V, Schmidt F, Weisblum Y, Jha D, Tankelevich M, Yee J, Shimeliovich I, Robbiani DF, Zhao Z, Gazumyan A, Hatziioannou T, Bjorkman PJ, Mehandru S, Bieniasz PD, Caskey M, Nussenzweig MC, Hagglof T, Schwartz RE, Bram Y, Martinez-Delgado G, Mendoza P, Breton G, Dizon J, Unson-O'Brien C, Patel R. Evolution of Antibody Immunity to SARS-CoV-2. bioRxiv [Preprint]. 2021 Jan 4:2020.11.03.367391. doi: 10.1101/2020.11.03.367391.
- Background: PubMed 32639941Dittadi R, Afshar H, Carraro P. The early antibody response to SARS-Cov-2 infection. Clin Chem Lab Med. 2020 Sep 25;58(10):e201-e203. doi: 10.1515/cclm-2020-0617. No abstract available.
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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.
Jeffrey Hyams, MD principal investigator
Connecticut Children's Medical Ctr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS-CoV-2, run by Connecticut Children's Medical Center 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 4 inclusion and 2 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 1 Apr 2025. 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.
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?
Presence of anti-SARS-CoV-2 Immunoglobulin G (IgG) (time frame: At the time of infusions for up to 2 years). 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 NCT04838834, which also lists 6 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 1 Apr 2025.