Covid-19 Living Data

Trial NCT04411680
Publication iLeukPulm - NCT04411680, Unpublished (2022) (results posted on registry)

Funding: Mixed (Partner Therapeutics, Inc, Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense's (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), under project agreement MCDC2006-012)
Conflict of interest: *

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / USA Follow-up duration (days): 90
Inclusion criteria	Patients aged ≥ 18 years Patients (or legally authorized decision maker) must provide informed consent Test positive for SARS-CoV-2 virus by PCR Admitted to hospital Presence of acute hypoxemia defined as (either or both): saturation below 93% on ≥ 2 L/min oxygen supplementation, PaO2/FiO2 below 350
Exclusion criteria	Patients requiring invasive (mechanical ventilation) or non-invasive (CPAP, BiPAP for hypoxemia) ventilation or ECMO (Note: oxygen supplementation using high flow oxygen systems or low flow oxygen systems would not exclude patients from this study) Intractable metabolic acidosis Cardiogenic pulmonary edema Hypotension requiring use of vasopressors Hyperferritinemia (serum ferritin ≥2,000 mcg/L) White blood cell count > 50,000/mm3 Participation in another interventional clinical trial for COVID-19 therapy Highly immunosuppressive therapy or anti-cancer combination chemotherapy within 24 hours prior to first dose of sargramostim Known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product Previous experience of severe and unexplained side effects during aerosol delivery of any kind of medical product Presence of any preexisting illness that, in the opinion of the Investigator, would place the patient at an unreasonably increased risk through participation in this study Pregnant or breastfeeding females Severe or uncontrolled pulmonary comorbid conditions, including systemic steroid dependent asthma, systemic steroid dependent COPD, oxygen dependent COPD, lung transplant, known interstitial lung disease, or cystic fibrosis.
Interventions
	Treatment Sargramostim 125 mcg inhaled twice daily for 5 days or 125mcg/m2 intravenously every day for 5 days
	Control Standard care
Participants
	Randomized participants : Sargramostim=79 Standard care=44
	Characteristics of participants N= 123 Mean age : NR 61 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=44 Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register 1. Change in Oxygenation Parameter of P(A-a)O2 Gradient by Day 6 [ Time Frame: 1-6 days ] The P(A-a)O2 gradient is a measure of how well the oxygen moves from the lungs into the bloodstream. Patients with a high gradient have less oxygen in the bloodstream. 2. Number of Patients Who Have Been Intubated by Day 14 [ Time Frame: 1-14 days ]
	In the report NR
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: Not reported
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	High
General comment	The trial registry, protocol and statistical analysis plane were used in data extraction and assessment of risk of bias. This is an unpublished study whose results have been reported in ClinicalTrials.gov. The trial was registered prospectively and no important changes were made to primary or secondary outcomes after recruitment start. The trial (n = 123) achieved its target sample size (n = 120). Trial data were updated on September 1st, 2022 with data extracted after contact with authors.