NCT05244096

Brief Summary

A retrospective chart review study to determine the effects of psychotropic medications and prior psychiatric diagnoses on COVID-19 patients' disease progression, and severity.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 15, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

3.2 years

First QC Date

February 15, 2022

Last Update Submit

April 3, 2024

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Hazard Ratio

    HR of using psych drugs or having psych diagnosis

    March 15 2020 to Nov 30 2021

Study Arms (1)

COVID+

COVID + positive individuals from March 15 2020 to Nov 30, 2021

Other: No intervention

Interventions

No interventionOTHER

Observational study

COVID+

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with COVID-19

You may qualify if:

  • \- Individuals with a positive COVID-19 test between March 15 2020 to November 30 2021 at Northwestern Medicine hospitals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwester Clinical Research Program

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jeffrey Rado, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 15, 2022

First Posted

February 17, 2022

Study Start

January 12, 2022

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

April 5, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)