Long COVID-19 and MAB Study

NCT05508295 | Unknown

• 1 other identifier: 02/01/2022
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

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.

  18-month study length, with a pilot reliability study.

Secondary Outcomes (2)

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

  3 months and 6 months follow-up.

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

  18-month study length

Study Arms (3)

COVID positive case with mAb treatment

COVID positive case having not received mAb treatment

COVID negative cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MultiCare Health System Research Institute: lead

Study Sites (1)

MultiCare Health System

Tacoma, Washington, 98405, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Hollis Zeng

CONTACT

2534037250; hzeng38@emory.edu

Jin Mou

CONTACT

2534037250; jin.mou@multicare.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 19, 2022
• Study Start: June 20, 2023
• Primary Completion: November 30, 2023
• Study Completion: January 31, 2024
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

US (1)