Targeted Steroids for ARDS Due to COVID-19 Pneumonia: A Pilot Randomized Clinical Trial
COVID-19, ARDS
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Corticosteroids, Dexamethasone, COVID-19 Pneumonia, ARDS
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Dexamethasone
Placebo
Patients assigned to the dexamethasone arm will receive an intravenous dose of 20 mg once daily from day 1 to day 5 which will be reduced to 10mg once daily from day 6 to day 10. Intravenous infusion bags divided into 10 doses will be provided at randomization by the investigational pharmacy. The time from randomization to time for first medication administration will be 4 hours or less. All infusions - dexamethasone and placebo - will be manufactured by the investigational pharmacy at the University of Colorado.
Participants randomized to the control group will received placebo intravenously for 10 days, one dose per day. Intravenous infusion bags divided into 10 doses will be provided at randomization by the investigational pharmacy. The placebo infusion bags will be as similar as possible to the dexamethasone infusion bags to ensure blinding.