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NCT04619706 · ClinicalTrials.gov registry record · Phase 2
Ultramicronized Palmitoylethanolamide (PEA) Treatment in Hospitalized Participants With COVID-19
A Phase 2 study, sponsored by Quantum Biopharma.
- Terminated
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
NCT04619706: Clinical Trial Phase 2 study, sponsored by Quantum Biopharma.
NCT04619706 is a Phase 2 study that was terminated before completion, run by Quantum Biopharma. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04619706, a Phase 2 study, was terminated before completion, sponsored by Quantum Biopharma.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
Study Summary
This study will measure the effect of FSD201 (ultramicronized PEA) + SoC vs placebo + SoC on Day 28, on disease progression in the confirmed coronavirus disease 2019 (COVID-19) patient population.
Primary Outcome
Disease progression will be defined as the percentage of participants who are not alive or who have respiratory failure. Respiratory failure will be defined as the need for invasive or non-invasive mechanical ventilation, high-flow oxygen, or extracorporeal membraneoxygenation (ECMO).
Interventions
- DRUG Placebo
- DRUG FSD201
- OTHER Standard of Care for Covid-19
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2020-12-14 |
| Est. Completion | 2021-08-24 |
| Phase | Phase 2 |
Why NCT04619706 stopped before completion
NCT04619706 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04619706 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04619706 about?
NCT04619706 is a clinical study titled "Ultramicronized Palmitoylethanolamide (PEA) Treatment in Hospitalized Participants With COVID-19". This study will measure the effect of FSD201 (ultramicronized PEA) + SoC vs placebo + SoC on Day 28, on disease progression in the confirmed coronavirus disease 2019 (COVID-19) patient population.
What is the current status of trial NCT04619706?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2020-12-14. Estimated completion is 2021-08-24.
What interventions are being tested in trial NCT04619706?
The interventions under investigation include: Placebo (DRUG), FSD201 (DRUG), Standard of Care for Covid-19 (OTHER).
Who is sponsoring clinical trial NCT04619706?
This trial is sponsored by Quantum Biopharma, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04619706's enrollment target sits among peer trials
53 1171st of 2000 higher than 820 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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