CovidResearchTrials by Shray Alag

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SargramostimWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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drug220 Control Wiki 0.50

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There is one clinical trial.

Clinical Trials

1 A Prospective, Randomized, Open-label, Interventional Study to Investigate the Efficacy of Sargramostim (Leukine®) in Improving Oxygenation and Short- and Long-term Outcome of COVID-19 (Corona Virus Disease) Patients With Acute Hypoxic Respiratory Failure.

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.

NCT04326920 COVID-19 Drug: Sargramostim Other: Control
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: by mean change in PaO2/FiO2 (PaO2=Partial pressure of oxygen; FiO2= Fraction of inspired oxygen)

Measure: 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: at end of 5 day treatment period

Secondary Outcomes

Measure: Incidence of AE (Adverse Event)

Time: at end of 5 day treatment period, 10 day period, 10-20 weeks

Measure: Incidence of SAEs (Serious Adverse Event)

Time: at end of 5 day treatment period, 10 day period, 10-20 weeks

Measure: Clinical Status using 6-point ordinal scale

Time: at end of 5 day treatment period, 10 day period, 10-20 weeks

Measure: Clinical Status using Clincal sign score

Time: at end of 5 day treatment period, 10 day period,10-20 weeks

Measure: Clinical Status using SOFA score (Sequential Organ Failure Assessment score),

Time: at end of 5 day treatment period, 10 day period, 10-20 weeks

Measure: Clinical Status using NEWS2 score (National Early Warning Score)

Time: at end of 5 day treatment period, 10 day period, 10-20 weeks

Description: demonstrated by bacterial or fungal culture

Measure: incidence of severe or life-threatening bacterial, invasive fungal or opportunistic infection

Time: during hospital admission (up to 28 days)

Measure: number of patients requiring initiation of mechanical ventilation

Time: during hospital admission (up to 28 days)

Measure: Number of deaths due to any cause at 4 weeks

Time: 4 weeks post inclusion

Measure: Number of deaths due to any cause at 20 weeks

Time: 20 weeks post inclusion

Description: defined by HS (Hemophagocytic Syndrome) score

Measure: number of patients developing features of secondary haemophagocytic lymphohistiocytosis

Time: at enrolment, end of 5 day treatment period, 10 day period, 10-20 weeks

Measure: long term Clinical status defined by 6-point ordinal scale

Time: 10-20 week

Measure: long term Clinical status defined by chest X-ray

Time: 10-20 weeks

Measure: long term Clinical status defined lung function

Time: 10-12 weeks

No related HPO nodes (Using clinical trials)