Status:
TERMINATED
Losmapimod Safety and Efficacy in COVID-19
Lead Sponsor:
Fulcrum Therapeutics
Conditions:
COVID-19
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
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 ac...
Detailed Description
The therapeutic hypothesis for the use of losmapimod in COVID-19 disease is that increased disease severity and consequent increased mortality is caused by p38 mitogen-activated protein kinase (MAPK)-...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04511819
Start Date
August 28 2020
End Date
March 31 2021
Last Update
March 13 2024
Active Locations (16)
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1
University of California Irvine - Irvine Medical Center
Irvine, California, United States, 92697
2
University of Miami
Miami, Florida, United States, 33136
3
University of South Florida
Tampa, Florida, United States, 33606
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215