Last Verified: | June/30/2020 |
First Submitted: | May/7/2020 |
Estimated Enrollment Submitted: | May/20/2020 |
First Posted: | May/25/2020 |
Last Update Submitted: | July/1/2020 |
Last Update Posted: | July/6/2020 |
Actual Study Start Date: | June/1/2020 |
Estimated Primary Completion Date: | May/31/2021 |
Estimated Study Completion Date: | May/31/2022 |
Study Type: | Interventional |
Allocation: | Randomized |
: | This is a randomized, double-blind, placebo-controlled clinical trial of iv Leukine® in 30 patients with confirmed COVID-19 and acute hypoxic respiratory failure. |
Primary Purpose: | Treatment |
Masking: | Double (Participant, Investigator) |
: | This is a double-blind study to investigate immediate versus delayed treatment of iv Leukine® in improving oxygenation and short- and long-term outcome of COVID-19 patients with acute hypoxic respiratory failure. The study will be unblinded at Day 5, or at any time within the first 5 days of study should the patient deteriorate clinically with need for supplemental oxygen FiO2 requirement ≥ 0.5. |
Arm | Intervention/treatment |
---|---|
Experimental: Group A: Treatment Group Day 1 - 5: Receive study medication Leukine® 125mcg/m2 body surface area daily (via infusion into the vein) in addition to standard of care treatments | |
Placebo Comparator: Group B: Placebo Group Day 1 - 5: Receive normal saline 0.9% daily (via infusion into the vein) in addition to standard of care treatments | Other: Group B: Placebo Group IV normal saline 0.9% for 5 days |
Experimental: Group C Day 6 - 10: Subjects in Group A who require mechanical ventilation to receive an additional 5 days of IV Leukine® 125mcg/m2 body surface area daily, in addition to standard of care treatments (based on the treating physician's assessment) | |
Experimental: Group D Day 6 - 10: Subjects from Group B to receive study medication (based on the treating physician's assessment), Leukine® 125mcg/m2 body surface area daily (via infusion into the vein) in addition to standard of care treatments | |
Experimental: Group E Day 11 - 15: Subjects in Group D who require mechanical ventilation to receive an additional 5 days of IV Leukine® 125mcg/m2 body surface area daily, in addition to standard of care treatments (based on the treating physician's assessment) |
Ages Eligible for Study: | 21 Years to 21 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria: | Inclusion Criteria: - SARS-CoV-2 PCR-confirmed COVID-19 infection - Presence of acute hypoxic respiratory failure defined as (either or both) - Saturation < 94% on room air or requiring supplemental oxygen - PaO2/FiO2 below 350 - Age 21-80 - Able and willing to provide informed consent Exclusion Criteria: - Patients who are already on supplemental oxygen of FiO2 ≥ 0.4 - Patients with known history of serious allergic reactions, including anaphylaxis, to human GM-CSF such as Leukine®, yeast-derived products, or any component of the product. - Mechanical ventilation before start of study - Patients enrolled in another investigational drug study - Pregnant or breastfeeding females (all female subjects of childbearing potential status must have negative pregnancy test at screening) - Patients with peripheral white blood cell count above 25,000 per microliter and/or active myeloid malignancy - Patients on high dose systemic steroids (> 20mg methylprednisolone or equivalent) - Patients on lithium carbonate therapy - Patients with serum ferritin >2000 mcg/ml (which will exclude ongoing HLH) |