COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04511819

Diego Cadavid, MD

clinicaltrials@fulcrumtx.com

2020-08-13

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: 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

- 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

2

Fulcrum Therapeutics

40

100

Brazil;Mexico;Peru;United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

52

Percentage of Participants Who Progressed to Death or Respiratory Failure by Day 28

None

Phase 3

[{"arm_notes": "", "treatment_id": 745, "treatment_name": "Losmapimod", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]