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OpenTrials
Completed

NCT Number: NCT04445506

Short Term Corticosteroids in SARS-CoV2 Patients

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.

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Key information

Conditions

Corticosteroids COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Dexamethasone Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV 2 Steroids Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Moderate disease with at least a 30% increase in CRP within 36 hours of admission, and with increasing oxygen requirements.
  • All patients with severe disease with evidence of escalating oxygen requirements
  • The presence of secondary bacterial infections as a probable cause of increasing CRP levels was excluded in all selected patients.
  • Pulmonary embolism and /or cardiac dysfunction were excluded as probable causes of worsening hypoxia in all selected patients.

Exclusion criteria

  • 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.
  • Patient with associated COPD exacerbation who would benefit from the use of steroids.
  • Patients with Diabetic ketoacidosis, hyperglycemic hyperosmolar state, active concurrent bacterial infections.
  • Patients with history of steroid-induced mania and/or psychosis.

Treatment and study plan

Dexamethasone

Drug

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 outcomes

  1. Effect on transfers to ICU and escalation of care needing mechanical ventilation

    Time frame: 2 months

Secondary outcomes

  1. Effect on length of stay

    Time frame: 2 months

  2. Change in CRP levels

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2020
Registry last updated
Jun 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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