Long COVID-19 and MAB Study

Recruiting

• Conditions: COVID-19

• Registration Number: NCT05508295
• Lead Sponsor: MultiCare Health System Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-17
• Study First Posted: 2022-08-19
• Status Verified: 2023-06
• Study Start: 2023-06-20
• Last Update Submitted: 2023-06-22
• Last Update Posted: 2023-06-26
• Primary Completion: 2023-11-30
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

MultiCare Health System; 🇺🇸 Tacoma, Washington, United States