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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2020
Source The Miriam Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone
4mg dexamethasone was given to some patients three times daily for 2 days, 2 times daily for 2 days, once daily for 2 days.

Locations

Country Name City State
United States The Miriam Hospital Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

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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