Status:
WITHDRAWN
Targeted Steroids for ARDS Due to COVID-19 Pneumonia: A Pilot Randomized Clinical Trial
Lead Sponsor:
University of Colorado, Denver
Conditions:
COVID-19
ARDS
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This trial will determine the safety and estimate efficacy of targeted corticosteroids in mechanically ventilated patients with the hyper-inflammatory sub phenotype of ARDS due to coronavirus disease ...
Detailed Description
Acute respiratory distress syndrome (ARDS) is a common, life-threatening pulmonary process which frequently requires mechanical ventilation and has a hospital mortality as high as 40%. No specific pha...
Eligibility Criteria
Inclusion
- Male or Female Adult ≥ 18 years of age at time of enrollment
- Laboratory confirmed SARS-CoV-2 infection determined by PCR within 14 days prior to randomization and no alternative explanation for current clinical condition
- Moderate or Severe ARDS (PaO2:FiO2 ratio ≤ 200mmHg) requiring mechanical ventilation within 7 days prior to randomization
- Hyper-inflammatory ARDS Sub-Phenotype defined as any one of the following:
- C-Reactive Protein (CRP) \> 100mg/dL
- D-Dimer \> 600ng/mL
- IL-6 \> 10pg/mL
- Willing and/or able to comply with study-related procedures and assessments
- Provide informed consent signed by study patient or legally acceptable representative
Exclusion
- Age \< 18 years
- In the opinion of the investigator, not expected to survive for more than 48 hours from screening
- Presence of any of the following abnormal laboratory values at screening
- Absolute neutrophil count (ANC) \< 2,000mm3
- Alanine Transferase (ALT) or Aspartate Transferase (AST) \> 5 times upper limit of normal
- Use of systemic corticosteroid therapy within 7 days of study enrollment
- Known or suspected active bacterial, fungal or mycobacterial infections including tuberculosis (TB)
- Participation in a double-blind clinical research study evaluating an investigational product or therapy within 3 months and less than 5 half-lives of investigational product prior to the screening visit. Exception: The use of remdesivir, hydroxychloroquine, or other treatments being used for COVID-19 infection in the context of an open-label study or compassionate use protocol is permitted
- Any physical examination findings, and/or history of any illness, concomitant medication or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study
- Prisoner
- Pregnancy
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04360876
Start Date
September 1 2020
End Date
January 30 2021
Last Update
October 28 2020
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