Trial NCT04326920
Publication Bosteels C, ResearchSquare (2021) (preprint)
Dates: 2020-03-25 to 2020-09-28
Funding: Mixed (Ghent University Hospital; Partner Therapeutics LLC (Lexington, MA) provided the study medication; The Ghent University Special Research Fund; VIB Grand Challenges program (Flanders Institute for Biotechnology); Chan Zuckerberg Initiative.)
Conflict of interest: Yes

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Belgium
Follow-up duration (days): 140
Inclusion criteria
  • 18-80 years of age
  • confirmed recent COVID-19 pneumonia (i.e. positive polymerase-chain reaction (PCR) assay, antigen detection test or serology < 2 weeks prior to randomization)
  • acute respiratory failure defined as a ratio of the partial arterial pressure of oxygen to the fraction of inspired oxygen (PaO2/FiO2) below 350 mmHg or blood oxygen saturation level (SpO2) below 93% on minimal 2 L/min supplemental oxygen.
Exclusion criteria
  • Known serious allergic reactions to yeast-derived products
  • lithium carbonate therapy
  • mechanical ventilation prior to randomization
  • peripheral white blood cell count above 25.000/μL and/or active myeloid malignancy
  • high dose systemic steroid therapy (> 20 mg methylprednisolone or equivalent) for a COVID-19-unrelated disorder
  • enrolment in another investigational study
  • pregnant or breastfeeding
  • ferritin levels > 2000 μg/mL (which will exclude ongoing CRS).
Interventions
Treatment
Sargramostim
125 mcg nebulized inhalation twice a day for 5 days (if intubated replaced by 125 μg/m2 body surface area intravenously once daily )
Control
Standard care

Participants
Randomized
participants :
Standard care=41
Sargramostim=40
Characteristics of participants
N= 81
Mean age : NR
51 males
Severity : Mild: n=4 / Moderate: n=71 / Severe: n=6 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Improvement in oxygenation at a dose of 250 mcg daily during 5 days improves oxygenation in COVID-19 patients with acute hypoxic respiratory failure [ Time Frame: at end of 5 day treatment period ] by mean change in PaO2/FiO2 (PaO2=Partial pressure of oxygen; FiO2= Fraction of inspired oxygen)
In the report
Improvement in oxygenation after 5 days of sargramostim treatment and/or standard of care. Oxygenation was assessed by the PaO2/FiO2 ratio and P(Aa)O2 gradient.
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

Yes
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the pre-print article, the trial registry, published and full protocols, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. The primary outcome in the article reflected that in the registry. The study (n = 81) achieved its target sample size (n = 80).
The study was updated on December 17th, 2021 with additional data from authors.