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RecruitingNCT05508295Updated Jun 26, 2023

Long COVID-19 and MAB Study

An observational study in COVID-19, sponsored by MultiCare Health System Research Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-26.

Sponsored by MultiCare Health System Research Institute · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • COVID-19
03

In context

COVID-19

7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 300 is above the median of 260 across 3,135 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

MultiCare Health System Research Institute is the lead sponsor of 14 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A small representative sample of up to 50 patients (25 hospitalized and alive at the time of the extraction) will be randomly selected and invited to test for the PRO instrument

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

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.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • COVID positive case with mAb treatment
  • COVID positive case having not received mAb treatment
  • COVID negative cases
06

What researchers measure

Primary outcomes

  1. 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.

    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.

    Time frame: 18-month study length, with a pilot reliability study.

Secondary outcomes

  1. Selected comorbidities, all-cause hospitalization and ER visits.

    Extracted from patients' electronic health records.

    Time frame: 3 months and 6 months follow-up.

  2. Patients' COVID vaccination and mAb therapy history will be verified based on self report and EHR.

    Time frame: 18-month study length

07

Study locations

1 of 1 sites recruiting
  • MultiCare Health System
    Tacoma, Washington 98405, United States
    • Jin Mou, MD, MSc, MPH, Ph.D · Contact · Jin.Mou@multicare.org · 253.403.7250
    • Jin Mou, MD, MSc, MPH, Ph.D · Principal investigator
    • Robin Underwood, RN, BSN, VA-BC · Sub investigator
    • Michael Garrett, DNP, ARNP, FNP-BC, MHA · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05508295
Lead sponsor
MultiCare Health System Research Institute
Responsible party
Sponsor
First posted
Aug 19, 2022
Start date
Jun 20, 2023
Primary completion
Nov 30, 2023 (estimated)
Completion
Jan 31, 2024 (estimated)
Last update
Jun 26, 2023

Study contacts

Hollis Zeng
Contact
hzeng38@emory.edu
2534037250
Jin Mou
Contact
jin.mou@multicare.org
2534037250

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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