Covid19NCT04830852
Pediatric COVID Outcomes Study (PECOS)
An observational study of Covid19 and MIS-C Associated With COVID-19, run by Children's National Research Institute at 2 sites in United States.
Trial summary
This is a multisite prospective observational study to evaluate the clinical sequelae of symptomatic and asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the pediatric population, including coronavirus disease 2019 (COVID-19) and multisystem inflammatory syndrome in children… Read more about this study
- Who is it for?
- Ages 0 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, MIS-C Associated With COVID-19, MIS-C Multisystem Inflammatory Syndrome in Children
- How many people
- 1,097 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jul 2021to 27 Feb 2026
- 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 0 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients aged 0 to 21 years with confirmed history of symptomatic SARS CoV-2 infection (including COVID-19), MIS C, or asymptomatic SARS CoV-2 infection (n = up to 1000), as well as healthy contacts (aged ≤21 years; n = up to 1000). Additionally, a parent or guardian of each participant will be enrolled to complete targeted questionnaires (n = up to 2000). Accrual ceiling is 5000 patients.
Who may be able to join
- Survivors and control cohorts:
- In order to be eligible to participate in this study as a survivor or as a control, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female aged 0 to 21 years (at the NIH CC, minimum age is 3 years).
- Willing to allow storage of samples and data for future research.
- At the NIH CC: Has a physician or clinic outside NIH to manage underlying medical conditions, or agrees to establish care with an outside physician or clinic for any medical conditions requiring treatment that may be diagnosed as a result of protocol participation.
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- In addition, an individual must meet all criteria for one of the following cohorts.
- Symptomatic survivor cohort (including MIS-C):
- Documented prior COVID-19 or MIS-C as evidenced by one of the following:
- detection of SARS-CoV-2 RNA or antigen in NP swab, saliva, sputum, or other sample source with Emergency Use Authorization (EUA)/approval from the US Food and Drug Administration (FDA) and a history of clinical manifestation compatible with COVID-19*; or
- positive SARS-CoV-2 antibody test using an assay that has received EUA from the FDA (negative SARS-CoV-2 RNA or antigen or never tested), and a history of clinical manifestation compatible with COVID-19*; or
- meeting CDC case definition for MIS-C (see Appendix 1).
- Onset of COVID-19/MIS-C symptoms is at least 4 weeks before baseline visit. *one or more of the following: ageusia, anosmia, chills, confusion, cough, rash, "COVID toes", diarrhea, dyspnea, fatigue, fever, headache, myalgia, nausea/vomiting, pneumonia, rhinorrhea.
- Asymptomatic survivor cohort:
- Documented prior SARS-CoV-2 infection as evidenced by one of the following:
- detection of SARS-CoV-2 RNA or antigen in NP swab, saliva, sputum, or other sample source with EUA/approval from the FDA without history of clinical manifestation compatible with COVID-19; or
- positive SARS-CoV-2 antibody test using an assay that has received EUA from the FDA without history of clinical manifestation compatible with COVID-19*.
- Positive SARS-CoV-2 RNA or antigen test is at least 4 weeks before baseline visit.
- one or more of the following: ageusia, anosmia, chills, confusion, cough, rash, "COVID toes", diarrhea, dyspnea, fatigue, fever, headache, myalgia, nausea/vomiting, pneumonia, rhinorrhea.
- Healthy contact (control) cohort:
- 1. No diagnosis of SARS-CoV-2 infection or current symptoms suggestive of COVID-19 and meets one of the following criteria:
- Lived in the same household as a participant with SARS-CoV-2 infection during the time of illness, or was within approximately 6 feet (2 meters) of the participant for a prolonged period of time, or having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on).
- Lives in an area affected by SARS-CoV-2 infection
- Parents and guardians:
- In order to participate in this study as a parent or guardian, an individual must meet all of the following criteria:
- Is a parent or guardian of a participant enrolled as a survivor or as a control.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Willing to allow storage of data for future research.
Who cannot join
- Survivors and controls:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Any symptoms suggestive of an ongoing infection within 15 days of baseline visit, including but not limited to fever > 38.2 °C, new or worsening respiratory symptoms (e.g., cough, dyspnea), or new or worsening gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea or abdominal pain).
- Any medical or mental health condition that, in the judgement of the principal investigator, would make the volunteer unable to participate in the study.
- Pregnancy.
- Parents and guardians:
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- An individual who meets any of the following criteria will be excluded from participation in this study:
- 1. Any medical or mental health condition that, in the judgement of the principal investigator, would make the volunteer unable to participate in the study.
- Co-enrollment: Participants may be co-enrolled in other clinical studies, including observational studies and therapeutic trials. However, the study staff should be informed of co-enrollment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health (NIH) / National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20852
Children's National Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: Pediatric SARS-CoV-2 and MIS-C Long-term Follow-up
This is a multisite prospective observational study to evaluate the clinical sequelae of symptomatic and asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the pediatric population, including coronavirus disease 2019 (COVID-19) and multisystem inflammatory syndrome in children (MIS-C), and characterize the immune response associated with these clinical presentations. Participants aged 21 years and younger with laboratory confirmed history of symptomatic or asymptomatic SARS-CoV-2 infection will visit the study sites for clinical and research evaluations and sample collection at schedules dependent on time since infection. Participants enrolled within 12 weeks after acute infection or positive test will be part of the "recovery group" and will attend study visits at baseline, every 3 months for the first 6 months, and subsequently every 6 months for a total of 3 years. Participants enrolled more than 12 weeks after acute infection or positive test will be in the "convalescent group" and will attend study visits at baseline and subsequently every 6 months for a total of 3 years.
Individuals (aged ≤21 years) without a diagnosis of SARS-CoV-2 infection or current symptoms suggestive of COVID-19 will serve as a control group and will attend visits for evaluations and sample collection at baseline and every 12 months for a total of 3 years. This protocol will establish a cohort of pediatric patients recovered from SARS CoV-2 infection and a biorepository for evaluation of the potential roles of host genetics, immune response, and other possible factors influencing long-term outcomes.
Parents or guardians of participants in all cohorts will also be enrolled for limited participation to complete questionnaires about how the family is impacted by the participant's health and SARS-CoV-2.
Read the detailed description
This study will establish a cohort of surviving pediatric patients with symptomatic (including COVID-19 and MIS-C) and asymptomatic SARS-CoV-2 infection to study the long-term sequelae of acute infection and the evolution of the immune response over time. Longitudinal follow-up of this cohort will provide important information about clinical sequelae of acute COVID-19 and MIS-C, characteristics of the immune response to SARS-CoV-2, genetic factors associated with long-term outcomes, and the extent and duration of protective immunity.
The study procedures include:
- Non-contrast chest computed tomography (CT) or chest X-ray: All participants will undergo 2 chest imaging procedures, one at baseline and one at the final study visit (year 3).
- Non-contrast cardiac magnetic resonance imaging (MRI): All participants will undergo 2 to 3 non-contrast cardiac MRI procedures during this study.
- Echocardiogram
- Electrocardiography (EKG)
- Pulmonary Function Test (PFT)
- Questionnaires: To complete the questionnaires will take approximately 25 to 64 minutes.
- Collection of blood (including for optional genetic testing), nasopharyngeal (NP) swab, urine, and stool.
Genetic testing (optional): This protocol involves genetic testing using whole genome sequencing (WGS) approaches for all participants.
Clinical photography (optional): Participants may decline photographs or place any restrictions on their use.
- Conditions
- Covid19, MIS-C Associated With COVID-19, MIS-C Multisystem Inflammatory Syndrome in Children, SARS-CoV2 Infection
- Keywords
- SARS-CoV-2, COVID-19, MIS-C, Post-COVID, Long-term effects, Pediatric, Children
- Medical subject headings
- COVID-19, pediatric multisystem inflammatory disease, COVID-19 related
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Recovery Group | Participants aged 21 years and younger and enrolled within 12 weeks after acute infection or positive test. These participants will attend study visits at baseline, every 3 months for the first 6 months, and subsequently every 6 months for a total of 3 years. | |
| Convalescent Group | Participants aged 21 years and younger and enrolled more than 12 weeks after acute infection or positive test. These participants will attend study visits at baseline and subsequently every 6 months for a total of 3 years. | |
| Healthy contacts | Individuals (aged ≤21 years) without a diagnosis of SARS-CoV-2 infection or current symptoms suggestive of COVID-19 will serve as a control group and will attend visits for evaluations and sample collection at baseline and every 12 months for a total of 3 years. | |
| Parents/guardians of participants | Parents or guardians of participants in all cohorts will also be enrolled for limited participation to complete questionnaires about how the family is impacted by the participant's health and SARS-CoV-2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and prevalence of medical sequelae, study procedures analysis
Incidence and prevalence of medical sequelae among symptomatic SARS-CoV-2 infection survivors, asymptomatic SARS CoV 2 infection survivors, and MIS-C survivors.
Measured: 6 years
Risk factors for medical sequelae, study procedures analysis
Risk factors for medical sequelae among symptomatic SARS CoV 2 infection survivors, asymptomatic SARS-CoV-2 infection survivors, and MIS-C survivors.
Measured: 6 years
Secondary outcomes (3)
Quality of life and social impact, study procedures analysis
Health-related quality of life and social impact in children and adolescents recovered from SARS-CoV-2 infection including parent/guardian and child assessments.
Measured: 6 years
Incidence and prevalence of reinfection, study procedures analysis
Incidence and prevalence of reinfection in previously infected and recovered SARS-CoV-2 and MIS-C survivors with and without vaccination.
Measured: 6 years
Biorepository, study procedures analysis
Establishment of a biorepository for additional biomarker analysis.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start23 Jul 2021
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- 1,097 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta DeBiasi, Children's National Research Institute
- Investigators
- Roberta DeBiasi, MD, MS, Principal investigator, Children's National Research InstituteGina A. Montealegre Sanchez, MD, MS, Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830852
- Sponsor's protocol ID
- Pro00015510
- Other IDs
- 21X125F1
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2021
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zember J, Turkbey EB, Chu E, Mateja A, Liang CJ, Barron K, Montealegre Sanchez GA, DeBiasi RL, Williams ME, Bulas DI. Pediatric SARS-CoV-2 long term outcomes study: chest radiographic and computed tomography findings at baseline. Pediatr Radiol. 2026 Jun 25. doi: 10.1007/s00247-026-06701-3. Online ahead of print.
PubMed 42347971He M, Burklow TR, Sable CA, Lacey SR, Bost JE, Lipton AJ, Koumbourlis AC, Curry MES, Choodar F, Lasota M, Park S, Dubale M, DiMaggio M, Rubenstein KB, Barron K, Montealegre Sanchez GA, DeBiasi RL, Harahsheh AS; PECOS Study Team. Ventricular Strain and Correlation with Cardiovascular Symptoms and Pulmonary Function Testing in Pediatric Patients with a History of COVID-19: Results from the Pediatric SARS-CoV-2 Long Term Outcomes Study. J Am Soc Echocardiogr. 2026 Jul;39(7):695-698. doi: 10.1016/j.echo.2026.03.006. Epub 2026 Mar 16. No abstract available.
PubMed 41850445Montealegre Sanchez GA, Yonts AB, Mateja A, Arrigoni LE, Wolff MT, Barrix MC, Weyers S, Edu MA, Falik RL, Geslak ML, Gierdalski M, Huq SR, Notarangelo LD, Bost JE, Liang CJ, Barron K, DeBiasi RL; PECOS Study Team. Pediatric SARS-CoV-2 outcomes study (PECOS): 12-month longitudinal analysis of post-COVID symptoms in infected versus uninfected participants. Pediatr Res. 2026 May 2. doi: 10.1038/s41390-026-05002-7. Online ahead of print.
PubMed 42070008Herbert LJ, Thurm A, Monaghan M, Bost JE, Wolff MT, Kader MC, Barron K, Montealegre Sanchez G, DeBiasi RL; PECOS Study Team. Mental and physical health differences between youth infected and uninfected by SARS-CoV-2: data from 2021 to 2023. J Pediatr Psychol. 2026 Apr 16:jsag024. doi: 10.1093/jpepsy/jsag024. Online ahead of print.
PubMed 41990330Montealegre Sanchez GA, Arrigoni LE, Yonts AB, Rubenstein KB, Bost JE, Wolff MT, Barrix MC, Bandettini WP, Boateng B, Bulas DI, Burklow TR, Carlyle KP, Chen M, Das S, Dewar RL, Dixon AA, Edu MA, Falik RL, Geslak ML, Gierdalski M, Harahsheh AS, Herbert LJ, Highbarger J, Huq SR, Ko A, Koumbourlis AC, Lacey SR, Lipton AJ, Monaghan M, Ndour AS, Olivieri LJ, Pillai DK, Rehm CA, Sable CA, Sachdev V, Thurm AE, Truong UT, Turkbey EB, Vilain E, Weyers S, White JS, Williams AA, Zember J, Liang CJ, Delaney M, Batshaw ML, Notarangelo LD, Wessel DL, Barron K, DeBiasi RL. Pediatric SARS-CoV-2 long term outcomes study (PECOS): cross sectional analysis at baseline. Pediatr Res. 2025 Aug;98(2):541-550. doi: 10.1038/s41390-024-03777-1. Epub 2024 Dec 18.
PubMed 39695262
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric SARS-CoV-2 and MIS-C Long-term Follow-up
- ClinicalTrials.gov ID
- NCT04830852
- Acronym / sponsor ID
- Pro00015510
- Conditions
- Covid19, MIS-C Associated With COVID-19, MIS-C Multisystem Inflammatory Syndrome in Children, SARS-CoV2 Infection
- Keywords
- SARS-CoV-2, COVID-19, MIS-C, Post-COVID, Long-term effects, Pediatric, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,097 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 5 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.
This is a multisite prospective observational study to evaluate the clinical sequelae of symptomatic and asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the pediatric population, including coronavirus disease 2019 (COVID-19) and multisystem inflammatory syndrome in children (MIS-C), and characterize the immune response associated with these clinical presentations. Participants aged 21 years and younger with laboratory confirmed history of symptomatic or asymptomatic SARS-CoV-2 infection will visit the study sites for clinical and research evaluations and sample collection at schedules dependent on time since infection. Participants enrolled within 12 weeks after acute infection or positive test will be part of the "recovery group" and will attend study visits at baseline, every 3 months for the first 6 months, and subsequently every 6 months for a total of 3 years. Participants enrolled more than 12 weeks after acute infection or positive test will be in the "convalescent group" and will attend study visits at baseline and subsequently every 6 months for a total of 3 years.
Individuals (aged ≤21 years) without a diagnosis of SARS-CoV-2 infection or current symptoms suggestive of COVID-19 will serve as a control group and will attend visits for evaluations and sample collection at baseline and every 12 months for a total of 3 years. This protocol will establish a cohort of pediatric patients recovered from SARS CoV-2 infection and a biorepository for evaluation of the potential roles of host genetics, immune response, and other possible factors influencing long-term outcomes.
Parents or guardians of participants in all cohorts will also be enrolled for limited participation to complete questionnaires about how the family is impacted by the participant's health and SARS-CoV-2.
Detailed description
This study will establish a cohort of surviving pediatric patients with symptomatic (including COVID-19 and MIS-C) and asymptomatic SARS-CoV-2 infection to study the long-term sequelae of acute infection and the evolution of the immune response over time. Longitudinal follow-up of this cohort will provide important information about clinical sequelae of acute COVID-19 and MIS-C, characteristics of the immune response to SARS-CoV-2, genetic factors associated with long-term outcomes, and the extent and duration of protective immunity.
The study procedures include:
- Non-contrast chest computed tomography (CT) or chest X-ray: All participants will undergo 2 chest imaging procedures, one at baseline and one at the final study visit (year 3).
- Non-contrast cardiac magnetic resonance imaging (MRI): All participants will undergo 2 to 3 non-contrast cardiac MRI procedures during this study.
- Echocardiogram
- Electrocardiography (EKG)
- Pulmonary Function Test (PFT)
- Questionnaires: To complete the questionnaires will take approximately 25 to 64 minutes.
- Collection of blood (including for optional genetic testing), nasopharyngeal (NP) swab, urine, and stool.
Genetic testing (optional): This protocol involves genetic testing using whole genome sequencing (WGS) approaches for all participants.
Clinical photography (optional): Participants may decline photographs or place any restrictions on their use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Recovery Group | – | –Participants aged 21 years and younger and enrolled within 12 weeks after acute infection or positive test. These participants will attend study visits at baseline, every 3 months for the first 6 months, and subsequently every 6 months for a total of 3 years. |
| Convalescent Group | – | –Participants aged 21 years and younger and enrolled more than 12 weeks after acute infection or positive test. These participants will attend study visits at baseline and subsequently every 6 months for a total of 3 years. |
| Healthy contacts | – | –Individuals (aged ≤21 years) without a diagnosis of SARS-CoV-2 infection or current symptoms suggestive of COVID-19 will serve as a control group and will attend visits for evaluations and sample collection at baseline and every 12 months for a total of 3 years. |
| Parents/guardians of participants | – | –Parents or guardians of participants in all cohorts will also be enrolled for limited participation to complete questionnaires about how the family is impacted by the participant's health and SARS-CoV-2. |
Who may qualify
- Ages
- 0 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients aged 0 to 21 years with confirmed history of symptomatic SARS CoV-2 infection (including COVID-19), MIS C, or asymptomatic SARS CoV-2 infection (n = up to 1000), as well as healthy contacts (aged ≤21 years; n = up to 1000). Additionally, a parent or guardian of each participant will be enrolled to complete targeted questionnaires (n = up to 2000). Accrual ceiling is 5000 patients.
Key inclusion criteria (28 listed)
- In order to be eligible to participate in this study as a survivor or as a control, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female aged 0 to 21 years (at the NIH CC, minimum age is 3 years).
- Willing to allow storage of samples and data for future research.
- At the NIH CC: Has a physician or clinic outside NIH to manage underlying medical conditions, or agrees to establish care with an outside physician or clinic for any medical conditions requiring treatment that may be diagnosed as a result of protocol participation.
Key exclusion criteria (9 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Any symptoms suggestive of an ongoing infection within 15 days of baseline visit, including but not limited to fever > 38.2 °C, new or worsening respiratory symptoms (e.g., cough, dyspnea), or new or worsening gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea or abdominal pain).
- Any medical or mental health condition that, in the judgement of the principal investigator, would make the volunteer unable to participate in the study.
- Pregnancy.
- An individual who meets any of the following criteria will be excluded from participation in this study:
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
Incidence and prevalence of medical sequelae, study procedures analysis
Time frame: 6 years
Incidence and prevalence of medical sequelae among symptomatic SARS-CoV-2 infection survivors, asymptomatic SARS CoV 2 infection survivors, and MIS-C survivors.
Risk factors for medical sequelae, study procedures analysis
Time frame: 6 years
Risk factors for medical sequelae among symptomatic SARS CoV 2 infection survivors, asymptomatic SARS-CoV-2 infection survivors, and MIS-C survivors.
3 secondary outcomes
Quality of life and social impact, study procedures analysis
Time frame: 6 years
Incidence and prevalence of reinfection, study procedures analysis
Time frame: 6 years
Biorepository, study procedures analysis
Time frame: 6 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 8 Oct 2026.
- Results publication: PubMed 42347971Zember J, Turkbey EB, Chu E, Mateja A, Liang CJ, Barron K, Montealegre Sanchez GA, DeBiasi RL, Williams ME, Bulas DI. Pediatric SARS-CoV-2 long term outcomes study: chest radiographic and computed tomography findings at baseline. Pediatr Radiol. 2026 Jun 25. doi: 10.1007/s00247-026-06701-3. Online ahead of print.
- Results publication: PubMed 41850445He M, Burklow TR, Sable CA, Lacey SR, Bost JE, Lipton AJ, Koumbourlis AC, Curry MES, Choodar F, Lasota M, Park S, Dubale M, DiMaggio M, Rubenstein KB, Barron K, Montealegre Sanchez GA, DeBiasi RL, Harahsheh AS; PECOS Study Team. Ventricular Strain and Correlation with Cardiovascular Symptoms and Pulmonary Function Testing in Pediatric Patients with a History of COVID-19: Results from the Pediatric SARS-CoV-2 Long Term Outcomes Study. J Am Soc Echocardiogr. 2026 Jul;39(7):695-698. doi: 10.1016/j.echo.2026.03.006. Epub 2026 Mar 16. No abstract available.
- Results publication: PubMed 42070008Montealegre Sanchez GA, Yonts AB, Mateja A, Arrigoni LE, Wolff MT, Barrix MC, Weyers S, Edu MA, Falik RL, Geslak ML, Gierdalski M, Huq SR, Notarangelo LD, Bost JE, Liang CJ, Barron K, DeBiasi RL; PECOS Study Team. Pediatric SARS-CoV-2 outcomes study (PECOS): 12-month longitudinal analysis of post-COVID symptoms in infected versus uninfected participants. Pediatr Res. 2026 May 2. doi: 10.1038/s41390-026-05002-7. Online ahead of print.
- Results publication: PubMed 41990330Herbert LJ, Thurm A, Monaghan M, Bost JE, Wolff MT, Kader MC, Barron K, Montealegre Sanchez G, DeBiasi RL; PECOS Study Team. Mental and physical health differences between youth infected and uninfected by SARS-CoV-2: data from 2021 to 2023. J Pediatr Psychol. 2026 Apr 16:jsag024. doi: 10.1093/jpepsy/jsag024. Online ahead of print.
- Results publication: PubMed 39695262Montealegre Sanchez GA, Arrigoni LE, Yonts AB, Rubenstein KB, Bost JE, Wolff MT, Barrix MC, Bandettini WP, Boateng B, Bulas DI, Burklow TR, Carlyle KP, Chen M, Das S, Dewar RL, Dixon AA, Edu MA, Falik RL, Geslak ML, Gierdalski M, Harahsheh AS, Herbert LJ, Highbarger J, Huq SR, Ko A, Koumbourlis AC, Lacey SR, Lipton AJ, Monaghan M, Ndour AS, Olivieri LJ, Pillai DK, Rehm CA, Sable CA, Sachdev V, Thurm AE, Truong UT, Turkbey EB, Vilain E, Weyers S, White JS, Williams AA, Zember J, Liang CJ, Delaney M, Batshaw ML, Notarangelo LD, Wessel DL, Barron K, DeBiasi RL. Pediatric SARS-CoV-2 long term outcomes study (PECOS): cross sectional analysis at baseline. Pediatr Res. 2025 Aug;98(2):541-550. doi: 10.1038/s41390-024-03777-1. Epub 2024 Dec 18.
- If you are interested in participating in this study, please complete this form. A study team member will contact you with additional information.Link provided by the sponsor.
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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.
Roberta DeBiasi, MD, MS principal investigator
Children's National Research Institute
Gina A. Montealegre Sanchez, MD, MS principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and MIS-C Associated With COVID-19, run by Children's National Research Institute at 2 sites 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 28 inclusion and 9 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 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Incidence and prevalence of medical sequelae, study procedures analysis (time frame: 6 years). 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?
On the ClinicalTrials.gov record for NCT04830852, which also lists 5 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 8 Oct 2026.