COVID-19NCT05244096
COVID-19 & Psychiatry: A Retrospective Chart Review
An observational study of COVID-19, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 65,000 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2022to 30 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COVID-19
Who may be able to join
- Individuals with a positive COVID-19 test between March 15 2020 to November 30 2021 at Northwestern Medicine hospitals.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwester Clinical Research Program
Chicago, Illinois, 60611
About this study
Official title: A Retrospective Chart Review Study to Determine the Effects of Psychotropic Medications and Prior Psychiatric Diagnoses on COVID-19 Patients' Disease Progression, and Severity.
A retrospective chart review study to determine the effects of psychotropic medications and prior psychiatric diagnoses on COVID-19 patients' disease progression, and severity.
Read the detailed description
The goal of this study would be to study the association between use of psychotropic medications and prior psychiatric diagnoses on COVID-19 patients' disease progression and severity.
- Conditions
- COVID-19
- Being tested
- No intervention
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| COVID+ | COVID + positive individuals from March 15 2020 to Nov 30, 2021 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hazard Ratio
HR of using psych drugs or having psych diagnosis
Measured: March 15 2020 to Nov 30 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start12 Jan 2022
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 65,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Rado, Northwestern University
- Investigators
- Jeffrey Rado, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244096
- Sponsor's protocol ID
- STU00214993
- Status last verified
- Apr 2024
- First submitted
- 15 Feb 2022
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Chart Review Study to Determine the Effects of Psychotropic Medications and Prior Psychiatric Diagnoses on COVID-19 Patients' Disease Progression, and Severity.
- ClinicalTrials.gov ID
- NCT05244096
- Acronym / sponsor ID
- STU00214993
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65,000 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A retrospective chart review study to determine the effects of psychotropic medications and prior psychiatric diagnoses on COVID-19 patients' disease progression, and severity.
Detailed description
The goal of this study would be to study the association between use of psychotropic medications and prior psychiatric diagnoses on COVID-19 patients' disease progression and severity.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID+ | – | Other: No interventionCOVID + positive individuals from March 15 2020 to Nov 30, 2021 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COVID-19
Key inclusion criteria (1 listed)
- Individuals with a positive COVID-19 test between March 15 2020 to November 30 2021 at Northwestern Medicine hospitals.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionObservational study | Other | COVID+ |
Primary outcome
Hazard Ratio
Time frame: March 15 2020 to Nov 30 2021
HR of using psych drugs or having psych diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Rado, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hazard Ratio (time frame: March 15 2020 to Nov 30 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.