Short Term Corticosteroids in SARS-CoV2 Patients

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04445506
• Other study ID #: 20-027
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Corticosteroids
• Covid19
• Dexamethasone
• SARS-CoV 2
• Steroids

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