Recruiting

MAB

Sponsor:

MultiCare Health System Research Institute

Code:

NCT05508295

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05508295

Start date

Jun 20, 2023

Status verified date

Jun, 2023

Completion date

Jan 31, 2024

Anticipated

Primary completion date

Nov 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

COVID positive case with mAb treatment

COVID positive case having not received mAb treatment

COVID negative cases

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Hollis Zeng

2534037250hzeng38@emory.edu

Jin Mou

2534037250jin.mou@multicare.org

Locations

MultiCare Health System

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Jin Mou, MD, MSc, MPH, Ph.D

253.403.7250Jin.Mou@multicare.org

Principal Investigator:

Jin Mou, MD, MSc, MPH, Ph.D

More Information

Sponsor

MultiCare Health System Research Institute

Last update posted

Jun 26, 2023

Last verified

Jun, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by MultiCare Health System Research Institute on 2023-06-26.