Long COVID-19 and MAB Study

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05508295
• Other study ID #: 02/01/2022
• Status: Recruiting
• Start date: June 20, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: June 2023
• Source: MultiCare Health System Research Institute
• Contact: Hollis Zeng
• Phone: 2534037250
• Email: hzeng38[@]emory.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 31, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
United States	MultiCare Health System	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
MultiCare Health System Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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