Losmapimod Safety and Efficacy in COVID-19

Stopped early · Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

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 hypothesizes 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 40 and older who are hospitalized with moderate COVID-19 disease.

Key facts

Study ID

NCT04511819

Run by

Fulcrum Therapeutics

People needed

52

Starts

2020-08-28

Expected to finish

2021-03-31

Last updated by the study team

2024-03-13

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able and willing to provide written informed consent
• Willing and able to comply with all study procedures.
• Confirmed infection with SARS-CoV-2 virus at or before the baseline visit by polymerase chain reaction (PCR) testing
• ≤7 days to the time of randomization from the time of collection of the specimen that tested positive for the SARS-CoV-2 virus
• Hospitalization at the time of the baseline visit
• ≥90% oxygen saturation on room air and/or ≥94% oxygen saturation on oxygen administration at 2 L/min by nasal cannula at the baseline visit
• Radiographic (X-ray or computed tomography scan, per local standard of care) and/or clinical evidence of pulmonary involvement consistent with COVID-19 at screening or baseline, per the judgment of the investigator
• Clinical syndrome consistent with COVID-19 at screening, per the judgment of the investigator (CDC 2020)
• CRP at screening >15 mg/L (i.e., >1.5 mg/dL) on local laboratory testing
• Agrees to practice an approved method of birth control

You may not qualify if…

• Inability to take oral medication at screening or baseline visit
• Evidence at screening or baseline of critical COVID-19 disease (e.g., cardiac failure, septic shock) or severe pulmonary involvement)
• Positive pregnancy test at screening for women of childbearing potential
• Lactating female at baseline for women of childbearing potential Note: A female will be considered eligible who is lactating at screening if she agrees to discontinue breastfeeding for the duration of the trial plus 14 days post last dose
• ≥5 × upper limit of normal (ULN) for alanine or aspartate aminotransferases or total bilirubin >1.5 × ULN at screening or known history of Child-Pugh Class C, hepatitis B or C, or HIV infection
• Glomerular filtration rate <30 mL/min/1.73 m2 at screening
• QTcF >450 msec for male or >470 msec for females or evidence of cardiac dysrhythmia at screening
• Significant history or evidence of clinically significant disorder, condition, current illness, illicit drug or other addiction, or disease that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
• Has been treated with immunomodulators or immunosuppressants including, but not limited to, interleukin (IL)-6 inhibitors, tumor necrosis factor (TNF) inhibitors, anti-IL-1 agents, and Janus kinase inhibitors, within 5 half-lives or 30 days, whichever is longer, prior to randomization, or plan to receive these agents any time during the study period
• Treatment with hydroxychloroquine/ chloroquine in the past 30 days or plan to receive these agents as part of investigational clinical trials or SOC any time during the study period
• Recent (within 30 days) or current participation in other COVID-19 therapeutic trials or expanded access programs
• Prior or current participation in COVID-19 vaccine trials

Where it is running

• University of California Irvine - Irvine Medical Center — Irvine, California, United States
• University of Miami — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Memorial Hermann Hospital South West — Houston, Texas, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States
• United Medical Memorial Hospital — Houston, Texas, United States
• Hospital Universitario Cassiano Antonio de Moraes-HUCAM/Hospital das Clinicas — Vitória, Espírito Santo, Brazil
• Santa Casa de Misericordia de Belo Horizonte — Belo Horizonte, Minas Gerais, Brazil
• Irmandade de Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Santa Catarina, Brazil
• Hospital Santa Paula — São Paulo, São Paulo, Brazil
• Hospital Civil Fray Antonio Alcalde — Guadalajara, Jalisco, Mexico
• Nuevo Hospital Civil de Guadalajara — Guadalajara, JC, Mexico
• JM Research Cuernavaca — Cuernavaca, Morelos, Mexico
• Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada, S.C. — Culiacán, Sinaloa, Mexico
• Hospital Nacional Carlos Alberto Seguín Escobedo - EsSalud Arequipa — Arequipa, AR, Peru

Full record on ClinicalTrials.gov

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