CorticosteroidsNCT04445506
Short Term Corticosteroids in SARS-CoV2 Patients
An observational study of Corticosteroids and Covid19, run by The Miriam Hospital at 1 site in United States.
Trial summary
The investigators reviewed the charts of SARS-CoV-2 patients with pneumonia and moderate to severely elevated CRP and worsening hypoxemia who were treated with early, short-term dexamethasone. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Corticosteroids, Covid19, SARS-CoV 2
- What is being tested?
- Dexamethasone
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2020to 31 May 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients aged 18 years and older with positive SARS-CoV2 test with CRP greater than 50 mg/L and having greater than 2L Oxygen requirement
Who may be able to join
- Moderate disease with at least a 30% increase in CRP within 36 hours of admission, and with increasing oxygen requirements.
- All patients with severe disease with evidence of escalating oxygen requirements
- The presence of secondary bacterial infections as a probable cause of increasing CRP levels was excluded in all selected patients.
- Pulmonary embolism and /or cardiac dysfunction were excluded as probable causes of worsening hypoxia in all selected patients.
Who cannot join
- All patients on other treatment modalities- Remdesivir and/or Convalescent plasma who showed evidence of clinical improvement as per decrease in CRP levels and/or oxygen requirements were excluded.
- Patient with associated COPD exacerbation who would benefit from the use of steroids.
- Patients with Diabetic ketoacidosis, hyperglycemic hyperosmolar state, active concurrent bacterial infections.
- Patients with history of steroid-induced mania and/or psychosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Short-term Use of Systemic Corticosteroids in COVID-19 Patients in Regard to Hospital Length of Stay, Morbidly and/or Mortality.
The investigators reviewed the charts of SARS-CoV-2 patients with pneumonia and moderate to severely elevated CRP and worsening hypoxemia who were treated with early, short-term dexamethasone.
- Conditions
- Corticosteroids, Covid19, SARS-CoV 2, Steroids, Dexamethasone
- Being tested
- Dexamethasone
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
4mg dexamethasone was given to some patients three times daily for 2 days, 2 times daily for 2 days, once daily for 2 days.
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV2 patients that received dexamethasone | Not described Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on transfers to ICU and escalation of care needing mechanical ventilation
Measured: 2 months
Secondary outcomes (2)
Effect on length of stay
Measured: 2 months
Change in CRP levels
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start1 Apr 2020
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CorticosteroidsStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kwame Dapaah-Afriyie, MD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445506
- Sponsor's protocol ID
- 20-027
- Status last verified
- May 2020
- First submitted
- 19 Jun 2020
- Last updated
- 24 Jun 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Short-term Use of Systemic Corticosteroids in COVID-19 Patients in Regard to Hospital Length of Stay, Morbidly and/or Mortality.
- ClinicalTrials.gov ID
- NCT04445506
- Acronym / sponsor ID
- 20-027
- Conditions
- Corticosteroids, Covid19, SARS-CoV 2, Steroids, Dexamethasone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 24 Jun 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.
The investigators reviewed the charts of SARS-CoV-2 patients with pneumonia and moderate to severely elevated CRP and worsening hypoxemia who were treated with early, short-term dexamethasone.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV2 patients that received dexamethasone | – | Drug: Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged 18 years and older with positive SARS-CoV2 test with CRP greater than 50 mg/L and having greater than 2L Oxygen requirement
Key inclusion criteria (4 listed)
- Moderate disease with at least a 30% increase in CRP within 36 hours of admission, and with increasing oxygen requirements.
- All patients with severe disease with evidence of escalating oxygen requirements
- The presence of secondary bacterial infections as a probable cause of increasing CRP levels was excluded in all selected patients.
- Pulmonary embolism and /or cardiac dysfunction were excluded as probable causes of worsening hypoxia in all selected patients.
Key exclusion criteria (4 listed)
- All patients on other treatment modalities- Remdesivir and/or Convalescent plasma who showed evidence of clinical improvement as per decrease in CRP levels and/or oxygen requirements were excluded.
- Patient with associated COPD exacerbation who would benefit from the use of steroids.
- Patients with Diabetic ketoacidosis, hyperglycemic hyperosmolar state, active concurrent bacterial infections.
- Patients with history of steroid-induced mania and/or psychosis.
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 |
|---|---|---|
| Dexamethasone4mg dexamethasone was given to some patients three times daily for 2 days, 2 times daily for 2 days, once daily for 2 days. | Drug | SARS-CoV2 patients that received dexamethasone |
Primary outcome
Effect on transfers to ICU and escalation of care needing mechanical ventilation
Time frame: 2 months
2 secondary outcomes
Effect on length of stay
Time frame: 2 months
Change in CRP levels
Time frame: 2 months
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 24 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
Kwame Dapaah-Afriyie, MD principal investigator
The Miriam Hospital
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 Corticosteroids and Covid19, run by The Miriam Hospital 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 4 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 24 Jun 2020. 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?
Effect on transfers to ICU and escalation of care needing mechanical ventilation (time frame: 2 months). 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 24 Jun 2020.