Covid19 Clinical Trial
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.
NCT number | NCT04445506 |
Other study ID # | 20-027 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2020 |
Est. completion date | May 31, 2020 |
Verified date | May 2020 |
Source | The Miriam Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | May 31, 2020 |
Est. primary completion date | May 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Moderate disease with at least a 30% increase in CRP within 36 hours of admission, and with increasing oxygen requirements. 2. All patients with severe disease with evidence of escalating oxygen requirements 3. The presence of secondary bacterial infections as a probable cause of increasing CRP levels was excluded in all selected patients. 4. Pulmonary embolism and /or cardiac dysfunction were excluded as probable causes of worsening hypoxia in all selected patients. Exclusion Criteria: 1. 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. 2. Patient with associated COPD exacerbation who would benefit from the use of steroids. 3. Patients with Diabetic ketoacidosis, hyperglycemic hyperosmolar state, active concurrent bacterial infections. 4. Patients with history of steroid-induced mania and/or psychosis. |
Country | Name | City | State |
---|---|---|---|
United States | The Miriam Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
The Miriam Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect on transfers to ICU and escalation of care needing mechanical ventilation | 2 months | ||
Secondary | Effect on length of stay | 2 months | ||
Secondary | Change in CRP levels | 2 months |
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