COVID-19NCT04561193
Investigation of Subsequent and Co-infections Associated With SARS-CoV-2 (COVID-19)
An observational study of COVID-19, run by Methodist Health System at 1 site in United States.
Trial summary
Multicenter retrospective chart review of patients admitted to any of the four Methodist Health System hospitals Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Observational
- How many people
- 417 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2020to 23 May 2022
- 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
- Adult, Older adult
Study population: Adult patients with positive COVID-19 PCR test admitted to Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas Medical Centers between February 1, 2020 and April 30, 2020.
Who may be able to join
- Patients admitted to Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas Medical Centers between February 1, 2020 and April 30, 2020
- >18 years old
- Positive SARS-CoV-2 (COVID-19) PCR test
Who cannot join
- Outpatient or emergency department visit
- Not admitted to an inpatient or observation status for >24 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Multicenter retrospective chart review of patients admitted to any of the four Methodist Health System hospitals
Read the detailed description
Multicenter retrospective chart review of patients admitted to any of the four Methodist Health System hospitals (Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas) between February 1 and April 30, 2020. All study center utilize Epic ® electronic health record (Verona, Wisconsin; www.epic.com) for which all data will be extracted from.
- Conditions
- COVID-19
- Being tested
- Observational
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort | Patients admitted to Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas Medical Centers between February 1, 2020 and April 30, 2020 with positive COVID-19 PCR test. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of subsequent and co-infections
Prevalence of subsequent and co-infections
Measured: Feb 2020 - April 2020
Secondary outcomes (2)
In-hospital mortality
In-hospital mortality
Measured: Feb 2020 - April 2020
Hospital length of stay (LOS)
Hospital length of stay (LOS)
Measured: Feb 2020 - April 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start30 May 2020
- Primary completion23 May 2022
- Study completion23 May 2022
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.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Crotty, PharmD, Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561193
- Sponsor's protocol ID
- 033.PHA.2020.A
- Status last verified
- May 2022
- First submitted
- 22 Sep 2020
- Last updated
- 23 Mar 2026
- 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 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Subsequent and Co-infections Associated With SARS-CoV-2 (COVID-19)
- ClinicalTrials.gov ID
- NCT04561193
- Acronym / sponsor ID
- 033.PHA.2020.A
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 30 May 2020 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 23 Sep 2020 (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.
Multicenter retrospective chart review of patients admitted to any of the four Methodist Health System hospitals
Detailed description
Multicenter retrospective chart review of patients admitted to any of the four Methodist Health System hospitals (Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas) between February 1 and April 30, 2020. All study center utilize Epic ® electronic health record (Verona, Wisconsin; www.epic.com) for which all data will be extracted from.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | Other: ObservationalPatients admitted to Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas Medical Centers between February 1, 2020 and April 30, 2020 with positive COVID-19 PCR test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with positive COVID-19 PCR test admitted to Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas Medical Centers between February 1, 2020 and April 30, 2020.
Key inclusion criteria (3 listed)
- Patients admitted to Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas Medical Centers between February 1, 2020 and April 30, 2020
- >18 years old
- Positive SARS-CoV-2 (COVID-19) PCR test
Key exclusion criteria (2 listed)
- Outpatient or emergency department visit
- Not admitted to an inpatient or observation status for >24 hours
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 |
|---|---|---|
| ObservationalObservational | Other | Retrospective Cohort |
Primary outcome
Prevalence of subsequent and co-infections
Time frame: Feb 2020 - April 2020
Prevalence of subsequent and co-infections
2 secondary outcomes
In-hospital mortality
Time frame: Feb 2020 - April 2020
Hospital length of stay (LOS)
Time frame: Feb 2020 - April 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- 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.
Matthew Crotty, PharmD principal investigator
Methodist Health System
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 Methodist Health System 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 23 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of subsequent and co-infections (time frame: Feb 2020 - April 2020). 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 23 Mar 2026.