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Short Term Corticosteroids in SARS-CoV2 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04445506
Recruitment Status : Completed
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
The Miriam Hospital

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
Corticosteroids Covid19 SARS-CoV 2 Steroids Dexamethasone Drug: Dexamethasone

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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 : April 1, 2020
Actual Primary Completion Date : May 31, 2020
Actual Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

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.




Primary Outcome Measures :
  1. Effect on transfers to ICU and escalation of care needing mechanical ventilation [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Effect on length of stay [ Time Frame: 2 months ]
  2. Change in CRP levels [ Time Frame: 2 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445506


Locations
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United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
The Miriam Hospital
Investigators
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Principal Investigator: Kwame Dapaah-Afriyie, MD The Miriam Hospital
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Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT04445506    
Other Study ID Numbers: 20-027
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents