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Ultramicronized Palmitoylethanolamide (PEA) Treatment in Hospitalized Participants With COVID-19

NCT04619706 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2022-12-05

No results posted yet for this 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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Quantum Biopharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2021-08-24
Completion
2021-08-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04619706 on ClinicalTrials.gov