Short Term Corticosteroids in SARS-CoV2 Patients

June 22, 2020 updated by: The Miriam Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect on transfers to ICU and escalation of care needing mechanical ventilation
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect on length of stay
Time Frame: 2 months
2 months
Change in CRP levels
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

May 31, 2020

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

June 19, 2020

First Submitted That Met QC Criteria

June 22, 2020

First Posted (Actual)

June 24, 2020

Study Record Updates

Last Update Posted (Actual)

June 24, 2020

Last Update Submitted That Met QC Criteria

June 22, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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