Status:
COMPLETED
Using GM-CSF as a Host Directed Therapeutic Against COVID-19
Lead Sponsor:
Singapore General Hospital
Conditions:
COVID
Sars-CoV2
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
Brief Summary
The coronavirus disease 2019 (COVID-19) has rapidly become a pandemic. COVID-19 poses a mortality risk of 3-7%, rising to 20% in older patients with co-morbidities. Of all infected patients, 15-20% wi...
Detailed Description
The hypothesis of the proposed intervention is that GM-CSF has profound effects on antiviral immunity, can provide the stimulus to restore immune homeostasis in the lung with acute lung injury post CO...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2022
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04400929
Start Date
June 2 2020
End Date
February 4 2022
Last Update
May 10 2022
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore