NCT05172011

Understanding the Long-term Impact of COVID on Children and Families

NIH RECOVER: A Multi-site Observational Study of Post-acute Sequalae of SARS-CoV-2 Infection in Children

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15,028 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Accepted

Summary

This is a combined retrospective and prospective, longitudinal, observational meta-cohort of individuals age 0-25 years who will enter the cohort with and without SARS-CoV-2 infection at varying stages before and after infection. Individuals with and without SARS-CoV-2 infection and with or without PASC symptoms will be followed to identify risk factors and occurrence of PASC. This study will be conducted in the United States and participants will be recruited through inpatient, outpatient, and community-based settings. Study data including age, demographics, social determinants of health, medical history, vaccination history, details of acute SARS-CoV-2 infection, overall health and physical function, and PASC symptoms will be reported by participants or collected from the electronic health record using a case report form at specified intervals. Biologic specimens will be collected at specified intervals, with some tests performed in local clinical laboratories and others performed by centralized research centers or banked in the Biospecimen Repository. Advanced clinical examinations and radiologic examinations will be performed at local study sites with cross-site standardization.

Detailed description

Ambidirectional longitudinal meta-cohort study (combined retrospective and prospective) with nested case-control studies.

Conditions

• SARS-CoV-2 Infection

Timeline

• Start date: 2022-03-01
• Primary completion: 2027-04-01
• Completion: 2027-05-23
• First posted: 2021-12-29
• Last updated: 2025-12-31

Locations

65 sites across 1 country: United States