Short Term Corticosteroids in SARS-CoV2 Patients

• Sponsor: The Miriam Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04445506
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 2
• Patients Per Site Per Month: 25.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Corticosteroids; Covid19; SARS-CoV 2; Steroids; Dexamethasone	Drug: Dexamethasone

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• 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.
• Actual Study Start Date: Apr 1, 2020
• Actual Primary Completion Date: May 31, 2020
• Actual Study Completion Date: May 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
SARS-CoV2 patients that received dexamethasone	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.

Outcome Measures

Primary Outcome Measures

1. Effect on transfers to ICU and escalation of care needing mechanical ventilation [2 months]

Secondary Outcome Measures

1. Effect on length of stay [2 months]

2. Change in CRP levels [2 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Miriam Hospital	Providence	Rhode Island	United States	02906

Sponsors and Collaborators

• The Miriam Hospital

Investigators

• Principal Investigator: Kwame Dapaah-Afriyie, MD, The Miriam Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Miriam Hospital
• ClinicalTrials.gov Identifier: NCT04445506
• Other Study ID Numbers: 20-027
• First Posted: Jun 24, 2020
• Last Update Posted: Jun 24, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Dexamethasone

Study Results

No Results Posted as of Jun 24, 2020