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SargramostimWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug1643 Normal Saline 0.9% Wiki 0.58
drug1204 Inhaled Hypertonic ibuprofen Wiki 0.58
drug636 Control Wiki 0.22
drug2326 Standard of care Wiki 0.13

Correlated MeSH Terms (5)

Name (Synonyms) Correlation
D012120 Respiration Disorders NIH 0.17
D012140 Respiratory Tract Diseases NIH 0.14
D012128 Respiratory Distress Syndrome, Adult NIH 0.05
D045169 Severe Acute Respiratory Syndrome NIH 0.03
D018352 Coronavirus Infections NIH 0.02

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There are 3 clinical trials

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

2 Using GM-CSF as a Host Directed Therapeutic Against COVID-19 - a Phase 2 Investigator Initiated Trial

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% will develop severe respiratory symptoms necessitating hospital admission. Around 5% of patients will require invasive mechanical ventilation, and up to 50% will die. Evidence in severe COVID-19 suggests that these patients experience cytokine storm and progressed rapidly with acute respiratory distress syndrome and eventual multi-organ failure. Early identification and immediate treatment of hyperinflammation is thus recommended to reduce mortality. Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) has been shown to be a myelopoietic growth factor that has pleiotropic effects in promoting the differentiation of immature precursors into polymorphonuclear neutrophils, monocytes/ macrophages and dendritic cells, and also in controlling the function of fully mature myeloid cells. It plays an important role in priming monocytes for production of proinflammatory cytokines under TLR and NLR stimulation. It has a broad impact on the processes driving DC differentiation and affects DC effector function at the mature state. Importantly, GM-CSF plays a critical role in host defense and stimulating antiviral immunity. Detailed studies have also shown that GM-CSF is necessary for the maturation of alveolar macrophages from foetal monocytes and the maintenance of these cells in adulthood. The known toxicology, pharmacologic and safety data also support the use of Leukine® in hypoxic respiratory failure and ARDS due to COVID-19. This study aims to recruit patients with evidence of pneumonia and hypoxia who have increased risk for severe disease and need for mechanical ventilation. The overall hypothesis is that GM-CSF has antiviral immunity, can provide the stimulus to restore immune homeostasis in the lung with acute lung injury from COVID-19, and can promote lung repair mechanisms, which would lead to improvement in lung oxygenation parameters.

NCT04400929 COVID Sars-CoV2 ARDS, Human Drug: Sargramostim Other: Normal Saline 0.9%
MeSH:Respiratory Distress Syndrome, Adult

Primary Outcomes

Description: To measure the effectiveness of Leukine® in restoring lung homeostasis, the primary endpoint of this intervention is measuring oxygenation after 5 days of intravenous treatment through assessment of pre-treatment and post-treatment ratio of PaO2/FiO2, and through measurement of the P(A-a)O2 gradient, which can easily be performed in the setting of clinical observation of inpatients.

Measure: Measuring oxygenation

Time: Day 1 to Day 6

3 A Phase 2 Trial Evaluating Sargramostim in Patients With COVID-19 Associated Acute Hypoxemia

The purpose of this research is to find out if a drug (sargramostim) also known as Leukine® could help patient recover faster from COVID-19. Sargramostim may help the lungs recover from the effects of COVID-19, and this research study will help to find this out.

NCT04411680 COVID-19 Sars-CoV2 Drug: Sargramostim Drug: Standard of care

Primary Outcomes

Measure: Change in oxygenation parameter of P(A-a)O2 gradient by Day 6

Time: 1-6 days

Measure: Percent of patients who have been intubated by Day 14

Time: 1-14 days

Secondary Outcomes

Measure: Change in ordinal scale

Time: 1-28 days

Measure: All cause 28-day mortality

Time: 1-28 days

Measure: Number of patients with treatment-emergent serious adverse events or clinically significant adverse drug reactions (ADRs)

Time: 1-58 days

No related HPO nodes (Using clinical trials)