Phase 4
N=81
Sargramostim in Patients With Acute Hypoxic Respiratory Failure Due to COVID-19 (SARPAC)
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04326920 ↗Enrolled (actual)
81
Serious AEs
14.8%
Results posted
Nov 2022
Primary outcome: Primary: Improvement in Oxygenation — 25.7; 29.7 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sargramostim (Drug); Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital, Ghent
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement in Oxygenation |
25.7; 29.7 | — |
| SECONDARY Mean Change in 6-point Ordinal Scale for Clinical Improvement |
0.3; 0.3 | — |
| SECONDARY Number of Days in Hospital |
8.5; 9.0 | — |
| SECONDARY Number of Participants With Nosocomial Infection no./Total no (%) |
2; 1 | — |
| SECONDARY Death |
2; 2 | — |
| SECONDARY Number of Participants Progressed to Mechanical Ventilation and/or ARDS |
7; 6 | — |
| SECONDARY Time to Clinical Sign Score < 6 for at Least 24h |
2.0; 3.0 | — |
| SECONDARY Change in Clinical Sign Score |
-2.0; -2.2 | — |
| SECONDARY Change in (National Early Warning Score2) NEWS2 Score |
-0.6; -0.4 | — |
| SECONDARY Change in Sequential Organ Failure Assessment (SOFA Score) |
-0.5; -0.4 | — |
| SECONDARY Change in Ferritin Level |
-90; -112 | — |
| SECONDARY Change in D-dimer Level |
-0.71; -0.44 | — |
| SECONDARY Change in CRP Level |
-43.6; -43.1 | — |
| SECONDARY Change in Lymphocyte Count |
0.45; 0.20 | — |
| SECONDARY Change in Eosinophil Count |
0.100; 0.005 | — |
| SECONDARY HRCT (High-Resolution Computed Tomography) Fibrosis Score |
100.8; 102.5 | — |
Summary
Phase IV study to evaluate the effectiveness of additional inhaled sargramostim (GM-CSF) versus standard of care on blood oxygenation in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure.
Eligibility Criteria
Inclusion Criteria
- Recent (≤2weeks prior to Randomization) confident diagnosis of COVID-19 confirmed by antigen detection and/or PCR (Polymerase Chain Reaction), and/or seroconversion or any other emerging and validated diagnostic test
- In some patients, it may be impossible to get a confident laboratory confirmation of COVID-19 diagnosis after 24h of hospital admission because viral load is low and/or problems with diagnostic sensitivity. In those cases, in absence of an alternative diagnosis, and with highly suspect bilateral ground glass opacities on recent ( 20 mg methylprednisolone or equivalent)
- patients on lithium carbonate therapy
- Patients enrolled in another investigational drug study
- Pregnant or breastfeeding females (all female subjects regardless of childbearing potential status must have negative pregnancy test at screening)
- Patients with serum ferritin >2000 mcg/ml (which will exclude ongoing HLH)
Data sourced from ClinicalTrials.gov (NCT04326920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.