Trials / Terminated
TerminatedNCT04619706
Ultramicronized Palmitoylethanolamide (PEA) Treatment in Hospitalized Participants With COVID-19
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIA Study of FSD201 (Ultramicronized PEA) + Standard of Care (SOC) Vs SOC in the Treatment of Hospitalized Patients With COVID-19
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- Quantum Biopharma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FSD201 | Tablets for oral administration. |
| DRUG | Placebo | Placebo tablets matched to FSD201 for oral administration. |
| OTHER | Standard of Care for Covid-19 | Standard of care for Covid-19 as determined by site PI |
Timeline
- Start date
- 2020-12-14
- Primary completion
- 2021-08-24
- Completion
- 2021-08-24
- First posted
- 2020-11-06
- Last updated
- 2022-12-05
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04619706. Inclusion in this directory is not an endorsement.