Long COVID-19 and MAB Study

June 22, 2023 updated by: MultiCare Health System Research Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • MultiCare Health System
        • Contact:
        • Principal Investigator:
          • Jin Mou, MD, MSc, MPH, Ph.D
        • Sub-Investigator:
          • Robin Underwood, RN, BSN, VA-BC
        • Sub-Investigator:
          • Michael Garrett, DNP, ARNP, FNP-BC, MHA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
COVID positive case with mAb treatment
COVID positive case having not received mAb treatment
COVID negative cases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
18-month study length, with a pilot reliability study.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MultiCare Health System Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2023

Primary Completion (Estimated)

November 30, 2023

Study Completion (Estimated)

January 31, 2024

Study Registration Dates

First Submitted

August 16, 2022

First Submitted That Met QC Criteria

August 17, 2022

First Posted (Actual)

August 19, 2022

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02/01/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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