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Losmapimod oral tabletWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug1877 Nitric Oxide Gas Wiki 0.58
drug2161 Placebo oral tablet Wiki 0.18

Correlated MeSH Terms (3)

Name (Synonyms) Correlation
D013577 Syndrome NIH 0.10
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Losmapimod in Adult Subjects With COVID-19 (LOSVID STUDY)

The therapeutic hypothesis for the use of losmapimod in COVID-19 disease is that increased mortality and severe disease is caused by p38 mitogen-activated protein kinase (MAPK)-mediated exaggerated acute inflammatory response resulting from SARS-CoV-2 infection. The study Sponsor hypothesize's that the early initiation of p38α/β inhibitor therapy in patients hospitalized with moderate COVID-19 who are at increased risk of a poor prognosis based on older age and elevated systemic inflammation will reduce clinical deterioration including progression to respiratory failure and death. To address this hypothesis, Fulcrum Therapeutics is conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that will evaluate the safety and efficacy of losmapimod versus placebo in subjects 50 and older who are hospitalized with moderate COVID-19 disease.

NCT04511819 COVID-19 Drug: Losmapimod oral tablet Drug: Placebo oral tablet

Primary Outcomes

Description: The efficacy of Losmapimod will be assessed by the development of progression to critical disease as evidence of mortality or development of respiratory failure by Day 28.

Measure: Day 28 Mortality

Time: Day 28

Secondary Outcomes

Description: The change from baseline in clinical disease status will be evaluated using the 9-point World Health Organization (WHO) ordinal scale: 0 indicating, no clinical evidence of SARS-CoV-2 infection and 8 indicating death.

Measure: Clinical Status Assessment

Time: Day 7 and Day 14

Description: The response to treatment with Losmapimod in COVID-19 patients will be assessed by the total number of study days not requiring oxygen supplementation.

Measure: Respiratory Failure Assessment

Time: Day 28

Description: To assess the effect on survival following treatment with Losmapimod, mortality will be evaluated by the number of days alive by Day 28.

Measure: Treatment Survival

Time: Day 28

Description: To evaluate the safety and tolerability of Losmapimod, the incidence of treatment-emergent adverse events will be assessed by clinically significant changes in laboratory test results and vital signs.

Measure: Treatment-Emergent Adverse Events

Time: Screening, Date of enrollment and Days 2-14 and 7 and 14 days after the last dose of study drug

Description: To characterize changes in SARS-CoV-2 infection following treatment with losmapimod versus placebo.

Measure: Treatment-Emergent Adverse Events

Time: Day 7

Other Outcomes

Description: The change from baseline in levels of C-reactive protein (CRP), a biomarker of systemic inflammatory response to infection with the SARS-CoV-2 virus will be evaluated in serum by immunoturbidimetric assay.

Measure: Changes in C-Reactive Protein

Time: Days 1, 4, 7 and 14

Description: The change from baseline in the levels of cytokines ( IFNγ, IL-2, IL-10 in normalized protein expression (NPX) and chemokines (CXCL10, CXCL9 in normalized protein expression (NPX)) in response to the SARS-CoV-2 virus in serum will be evaluated by Olink immunoassay panel.

Measure: Changes in Circulating Proteins

Time: Days 1, 4, 7 and 14

No related HPO nodes (Using clinical trials)