A Multi-site Observational Study: NIH RECOVER Study of Long COVID in Adults

Primary Objective

? Characterize the incidence and prevalence of sequelae of SARS-CoV-2 infection. ? Characterize the spectrum of clinical symptoms, subclinical organ dysfunction, natural history, and distinct phenotypes identified as sequelae of SARS-CoV-2 infection. ? Define the biological mechanisms underlying pathogenesis of the sequelae of SARS-CoV-2 infection.

Study category: Infectious Diseases

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Description

This is a longitudinal study enrolling individuals with and without SARS-CoV-2 infection at varying stages before and after infection and with or without post-acute sequelae of SARS-CoV-2 (PASC). The aim is to better understand risk factors and occurrence of PASC. 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 symptom screen will be reported by subjects or collected from the electronic health record using a case report form at specified intervals. Biologic specimens will be collected at specified intervals.

Details
Age

Adult

Eligibility

At least 18 years of age

Inclusion Criteria •Patients will be eligible for inclusion if they are at least 18 years of age •Infected individuals will have suspected, probable, or confirmed SARS-CoV-2 infection as defined by WHO criteria within 24 months of enrollment, or positive SARS-CoV-2 infection-specific antibody testing Adults with suspected SARS-CoV-2 infection An adult qualifies as having suspected SARS-CoV-2 infection if meeting criteria a, b or c below: a) Patients who meet the following clinical criteria plus one of the epidemiological criteria: Clinical criteria: Acute onset of fever and cough OR acute onset of any three of more of the following signs or symptoms: fever, cough, general weakness /fatigue, headache, myalgia, sore throat, coryza, dyspnea, anorexia/nausea/vomiting, diarrhea, altered mental status. Epidemiological criteria: i. Residing or working in an area with a high risk of transmission of virus: closed residential settings, humanitarian settings such as camp and camp-like settings for displaced persons; anytime within the 14 days before symptom onset; or ii. Residing or travel to an area with community transmission anytime within the 14 days before symptom onset; or iii. Working in any health care setting, including within health facilities or within the community; anytime within the 14 days before symptom onset. b) A patient with severe acute respiratory illness c) An asymptomatic person not meeting epidemiologic criteria with a positive SARS-CoV-2 Antigen-RDT. Adults with probable SARS-CoV-2 infection An adult qualifies as having probable SARS-CoV-2 infection if meeting any one of a-d below: a) A patient who meets clinical criteria for suspected SARS-CoV-2 AND is a contact of a probable or confirmed case or linked to a COVID-19 cluster; b) A suspect case with chest imaging showing findings suggestive of COVID-19 disease; c) A person with recent onset loss of smell or loss of taste in the absence of any other identified cause; d) Death, not otherwise explained, in an adult with respiratory distress preceding death AND was a contact of a probable or confirmed case or linked to a COVID-19 cluster Adults with confirmed SARS-CoV-2 infection An adult qualifies as having confirmed SARS-CoV-2 infection if meeting any one of a-d below: a) Any person with a positive Nucleic Acid Amplification Test (NAAT); b) Any person with a positive SARS-CoV-2 Antigen-RDT AND meeting either the probable case definition or suspect criteria A OR B; c) An asymptomatic person with a positive SARS-CoV-2 Antigen-RDT who is a contact of a probable or confirmed case d) Any person with a positive SARS-CoV-2 nucleocapsid protein antibody test OR a positive SARS-CoV-2 spike protein antibody test IF not vaccinated Adults with no SARS-Cov-2 Infection •Does not meet WHO criteria for a suspected, probable, or confirmed case of SARS-CoV-2 infection, AND •Documented negative SARS-CoV-2 testing from a respiratory specimen (PCR or antigen testing) at the time of enrollment/screening and negative SARS-CoV-2 nucleocapsid protein antibody and spike protein antibody test (if not vaccinated) at the time of enrollment, AND •Live in the same communities or recruited from the same sources as those in the SARS-CoV-2 infected cohort, AND •Either not hospitalized for any reason in prior 3 months, or hospitalized (with or without ICU stay) within the prior 3 months •Note: uninfected individuals may participate independent of their vaccination status Exclusion Criteria •Individuals who have not yet reached the age of majority •Unable to provide consent •Individuals in hospice care •Any serious medical condition which would prevent long-term participation •Individuals participating in the study NIH RECOVER-Pediatric: Understanding the long-term impact of COVID on children and families • Incarcerated individuals

Type of Study

Observational

Locations

University of Colorado Hospital

Principal Investigator
Kristine Erlandson,  MD

Kristine Erlandson, MD

Study ID

Protocol Number: 21-4528

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