Long COVID-19 and MAB Study

Setting up a Community Based Patient Cohort to Understand Long COVID: Monoclonal Antibody and Post-Infection COVID Vaccine Administration as the FOCI

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05508295

Enrollment

300

Registered

2022-08-19

Start date

2023-06-20

Completion date

2024-01-31

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Brief summary

This study will be observational only. It will provide real-world evidence generated from a representative and large-scale COVID patient base. The adoption, pilot testing and use of NIH PROs among viral tested patients with research purpose on long COVID will be unique and innovative. With the existing and proven scientific rigor, NIH PRO system will be adopted, then modified and tailored to form the long hauler specific, comprehensive instrument, helping generalize future knowledge regarding COVID-infected patients.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Have been tested for COVID at one of the MultiCare facilities, * AND 18 years old or older at the viral test, * AND have no problem understanding English or Spanish.

Exclusion criteria

* Pediatric patients younger than 18 years old at the time of testing, * OR patients who are pregnant, * OR patients who plan to get pregnant in 3 months, * OR patients who are hospitalized at the time of recruitment, * OR patients who have cognitive impairment(s) at the recruitment.

Design outcomes

Primary

Measure	Time frame	Description
Adopt the NIH PROMIS system (The Assessment Center Instrument Library, which includes all Fixed Length Short Form and Computer Adaptive Test/Item Bank instruments from PROMIS) to construct a modified comprehensive PRO instrument.	18-month study length, with a pilot reliability study.	Using a modified NIH PRO measurement system. This system will involve different domains and instruments. Patients will answer PRO questions at the time of recruitment (baseline), then followed up 3 months and 6 months after the first survey (follow-up). The modified comprehensive PRO instrument will specifically ask patients to report symptoms based on their health status within a fixed time window, and at the time when the survey questions are given.

Secondary

Measure	Time frame	Description
Selected comorbidities, all-cause hospitalization and ER visits.	3 months and 6 months follow-up.	Extracted from patients' electronic health records.
Patients' COVID vaccination and mAb therapy history will be verified based on self report and EHR.	18-month study length	—

Countries

United States

Contacts

Primary ContactHollis Zeng

hzeng38@emory.edu2534037250

Backup ContactJin Mou

jin.mou@multicare.org2534037250

Outcome results