Covid 19NCT05595031
Evaluation of the Clinical Impact of Corticosteroid Duration on SARS-CoV-2 (COVID-19 WHO)
An observational study of Covid 19, run by Methodist Health System at 1 site in United States.
Trial summary
The purpose of this project is to evaluate the clinical impact of the use of glucocorticoids beyond 10 days for patients with critical COVID-19 at MDMC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid 19
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2021to 19 Oct 2023
- 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: This is a retrospective chart review study limited to only patients meeting inclusion and exclusion criteria. Determination of the clinical impact of corticosteroid dosing will be aided by a larger cohort of patients. We plan to conduct the retrospective chart review of all patients identified during the study period 08/01/2020 to 01/31/2021 that meet inclusion and exclusion criteria.
Who may be able to join
- > 18 years of age
- ICU admission at any time during first hospital admission for COVID-19
- COVID-19 diagnosis
- Dexamethasone, hydrocortisone, or methylprednisolone therapy for SARS-CoV-2 infection
Who cannot join
- Prior ICU admission before study start date
- Death or hospice before day 11 of hospital admission
- Still admitted at time of data analysis from index admission
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Methodist Dallas Medical Center
Dallas, Texas, 75052
Crystee Cooper, DHEd, 214-947-1280, clinicalresearch@mhd.com
Zaid Haddadin, MS, 2149471280, clinicalresearch@mhd.com
About this study
Official title: Evaluation of the Clinical Impact of Corticosteroid Duration on SARS-CoV-2 Acute Respiratory Distress Syndrome
The purpose of this project is to evaluate the clinical impact of the use of glucocorticoids beyond 10 days for patients with critical COVID-19 at MDMC.
Read the detailed description
The purpose of this project is to evaluate the clinical impact of the use of glucocorticoids beyond 10 days for patients with critical COVID-19 at MDMC.
Glucocorticoids have become standard of care for critical COVID-19 patients, with a mortality benefit shown in several recent randomized control trials. Critical COVID-19 can lead to ARDS, in which the use of glucocorticoids has uncertain benefit beyond 10 days. Studies have shown increased harm in the use of these agents in persistent ARDS (≥14 days). Additionally, studies supporting the use of steroids in COVID-19 only used steroids for a limited time (up to 10 days). Given that these agents can possibly lead to increased patient morbidity and mortality, prolonged use of glucocorticoids is not without risk. To date, there have been no studies evaluating the clinical impact of glucocorticoid use beyond 10 days for treatment of critical COVID-19.
- Conditions
- Covid 19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause in-hospital mortality at 28 days
All-cause in-hospital mortality at 28 days
Measured: 28 days
Secondary outcomes (7)
Bacteremia
growth of a pathogenic organism in 1 of 4 blood culture sites; blood cultures are considered contaminants if 1 of 4 sets grows a typically non-pathogenic organism or if the clinical team determines the organism a contaminant. To determine if the use of corticosteroids beyond 10 days increases the incidence of secondary infection or impacts duration of MV and length of stay in critical COVID-19.
Measured: 28 days
Mechanical ventilator-free days
number of days alive and breathing without assistance
Measured: 28 days
ICU LOS
number of days alive and admitted to the ICU
Measured: 28 days
Hospital LOS
number of days alive and admitted to MDMC
Measured: 28 days
hospital acquired pneumonia (HAP)
New lung infiltrate after 48 hrs of admission, positive respiratory culture, AND clinical evidence suggestive of new infection. To determine if the use of corticosteroids beyond 10 days increases the incidence of secondary infection or impacts duration of MV and length of stay in critical COVID-19.
Measured: 28 days
ventilator-associated pneumonia (VAP)
VAP arises >48 hrs after intubation. To determine if the use of corticosteroids beyond 10 days increases the incidence of secondary infection or impacts duration of MV and length of stay in critical COVID-19.
Measured: 28 days
C. diff infection (CDI)
Acute onset of diarrhea (> 3 unformed or watery stools occurring in < 24 hours) AND positive test for toxigenic C. difficile or pseudomembranous colitis on endoscopy OR high clinical suspicion. To determine if the use of corticosteroids beyond 10 days increases the incidence of secondary infection or impacts duration of MV and length of stay in critical COVID-19.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start19 Oct 2021
- Primary completion19 Oct 2023 (estimated)
- Study completion19 Oct 2023 (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.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristen Rahmanzadeh, PharmD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595031
- Sponsor's protocol ID
- 044.PHA.2021.D
- Status last verified
- Oct 2022
- First submitted
- 24 May 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Impact of Corticosteroid Duration on SARS-CoV-2 Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT05595031
- Acronym / sponsor ID
- 044.PHA.2021.D
- Conditions
- Covid 19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 19 Oct 2023 (estimated)
- Study completion
- 19 Oct 2023 (estimated)
- First posted
- 26 Oct 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.
The purpose of this project is to evaluate the clinical impact of the use of glucocorticoids beyond 10 days for patients with critical COVID-19 at MDMC.
Detailed description
The purpose of this project is to evaluate the clinical impact of the use of glucocorticoids beyond 10 days for patients with critical COVID-19 at MDMC.
Glucocorticoids have become standard of care for critical COVID-19 patients, with a mortality benefit shown in several recent randomized control trials. Critical COVID-19 can lead to ARDS, in which the use of glucocorticoids has uncertain benefit beyond 10 days. Studies have shown increased harm in the use of these agents in persistent ARDS (≥14 days). Additionally, studies supporting the use of steroids in COVID-19 only used steroids for a limited time (up to 10 days). Given that these agents can possibly lead to increased patient morbidity and mortality, prolonged use of glucocorticoids is not without risk. To date, there have been no studies evaluating the clinical impact of glucocorticoid use beyond 10 days for treatment of critical COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective chart review study limited to only patients meeting inclusion and exclusion criteria. Determination of the clinical impact of corticosteroid dosing will be aided by a larger cohort of patients. We plan to conduct the retrospective chart review of all patients identified during the study period 08/01/2020 to 01/31/2021 that meet inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- > 18 years of age
- ICU admission at any time during first hospital admission for COVID-19
- COVID-19 diagnosis
- Dexamethasone, hydrocortisone, or methylprednisolone therapy for SARS-CoV-2 infection
Key exclusion criteria (3 listed)
- Prior ICU admission before study start date
- Death or hospice before day 11 of hospital admission
- Still admitted at time of data analysis from index admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause in-hospital mortality at 28 days
Time frame: 28 days
All-cause in-hospital mortality at 28 days
7 secondary outcomes
Bacteremia
Time frame: 28 days
Mechanical ventilator-free days
Time frame: 28 days
ICU LOS
Time frame: 28 days
Hospital LOS
Time frame: 28 days
hospital acquired pneumonia (HAP)
Time frame: 28 days
ventilator-associated pneumonia (VAP)
Time frame: 28 days
C. diff infection (CDI)
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
Related trials for Covid 19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Kristen Rahmanzadeh, PharmD principal investigator
The Methodist Hospital Research Institute
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 4 inclusion and 3 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 26 Oct 2022. 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?
Contact Crystee Cooper, DHEd (214-947-1280, clinicalresearch@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause in-hospital mortality at 28 days (time frame: 28 days). 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 26 Oct 2022.