Losmapimod Safety and Efficacy in COVID-19 (LOSVID)

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19 pandemic, COVID-19 virus disease, COVID-19 virus infection, SARS-CoV-2 infection, coronavirus disease 2019, 2019 novel coronavirus disease, 2019 novel coronavirus infection Read More

Inclusion Criteria:

• Able and willing to provide written informed consent
• Willing and able to comply with all study procedures
• Age ≥50 years at time of screening
• 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

Exclusion Criteria:

• 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