Targeted Steroids for ARDS Due to COVID-19 Pneumonia: A Pilot Randomized Clinical Trial

• Status: Withdrawn
• Trial end date: 2021-01-30
• Target enrollment: 0
• Participant gender: All

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 2019 (COVID-19) by implementing a Phase 2A clinical trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

1. Male or Female Adult ≥ 18 years of age at time of enrollment

2. Laboratory confirmed SARS-CoV-2 infection determined by PCR within 14 days prior to randomization and no alternative explanation for current clinical condition

3. Moderate or Severe ARDS (PaO2:FiO2 ratio ≤ 200mmHg) requiring mechanical ventilation within 7 days prior to randomization

4. Hyper-inflammatory ARDS Sub-Phenotype defined as any one of the following:

1. C-Reactive Protein (CRP) > 100mg/dL

2. D-Dimer > 600ng/mL

3. IL-6 > 10pg/mL

5. Willing and/or able to comply with study-related procedures and assessments

6. Provide informed consent signed by study patient or legally acceptable representative

Exclusion Criteria:

1. Age < 18 years

2. In the opinion of the investigator, not expected to survive for more than 48 hours from screening

3. Presence of any of the following abnormal laboratory values at screening

1. Absolute neutrophil count (ANC) < 2,000mm3

2. Alanine Transferase (ALT) or Aspartate Transferase (AST) > 5 times upper limit of normal

4. Use of systemic corticosteroid therapy within 7 days of study enrollment

5. Known or suspected active bacterial, fungal or mycobacterial infections including tuberculosis (TB)

6. 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

7. 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

8. Prisoner

9. Pregnancy