|drug1761||Human Biological samples Wiki||1.00|
|drug2981||Placebo oral tablet Wiki||0.18|
|D045169||Severe Acute Respiratory Syndrome NIH||0.04|
|D018352||Coronavirus Infections NIH||0.04|
There is one clinical trial.
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.
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
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
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)) in response to the SARS-CoV-2 virus in serum will be evaluated using the Olink immunoassay panel.Measure: Changes in Levels of Cytokines Time: Days 1, 4, 7 and 14
Description: The change from baseline in the levels of chemokines (CXCL10, CXCL9 in normalized protein expression (NPX)) in response to the SARS-CoV-2 virus in serum will be evaluated using the Olink immunoassay panel.Measure: Changes in Levels of Chemokines Time: Days 1, 4, 7 and 14
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports