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NCT04511819 · ClinicalTrials.gov registry record · Phase 3
Losmapimod Safety and Efficacy in COVID-19
A Phase 3 study, sponsored by Fulcrum Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 52
- Enrollment target
NCT04511819: Clinical Trial Phase 3 study, sponsored by Fulcrum Therapeutics.
NCT04511819 is a Phase 3 study that was terminated before completion, run by Fulcrum Therapeutics. The registered enrollment target is 52 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04511819, a Phase 3 study, was terminated before completion, sponsored by Fulcrum Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 52 participants
- Enrollment target
Study 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 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.
Primary Outcome
Respiratory failure was defined as either need for mechanical ventilation (invasive or non-invasive) or high flow oxygen (defined by greater than 15 liters per minute \[LPM\] flow of oxygen to maintain oxygen saturation between 90% and 95%), sustained for at least 48 hours, at any time during the study. The fitted logistic regression model was used to predict the response rate for every participant in the study who had received the treatment or the control intervention. The efficacy of Losmapimo
Interventions
- DRUG Placebo oral tablet
- DRUG Losmapimod oral tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2020-08-28 |
| Est. Completion | 2021-03-31 |
| Phase | Phase 3 |
Why NCT04511819 stopped before completion
NCT04511819 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT04511819 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04511819 about?
NCT04511819 is a clinical study titled "Losmapimod Safety and Efficacy in COVID-19". 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 ...
What is the current status of trial NCT04511819?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 52 participants. The study started on 2020-08-28. Estimated completion is 2021-03-31.
What interventions are being tested in trial NCT04511819?
The interventions under investigation include: Placebo oral tablet (DRUG), Losmapimod oral tablet (DRUG).
Who is sponsoring clinical trial NCT04511819?
This trial is sponsored by Fulcrum Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04511819's enrollment target sits among peer trials
52 1841st of 2000 higher than 159 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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