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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID: NCT04619706
Run by: Quantum Biopharma
People needed: 53
Starts: 2020-12-14
Expected to finish: 2021-08-24
Last updated by the study team: 2022-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Must be willing and able to give informed consent to participate in the study
Has admitted to a hospital and has a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test by standard reverse transcription-polymerase chain reaction (RT-PCR) assay or equivalent test
Has the presence of any symptom(s) suggestive of moderate or severe systemic illness with COVID-19 on Day 1 such as the presence of fever (greater than or equal to (>=)38.0 degree Celsius [>=100.4 degree fahrenheit] by any route), "feeling hot," "feeling sweaty," headache, malaise, fatigue, muscle pain, diarrhea, nausea, vomiting, cough, sore throat, or shortness of breath upon exertion and/or at rest, or respiratory distress
Has the presence of moderate to severe clinical signs indicative of moderate or severe illness with COVID-19 on Day 1. A. Moderate: (1) Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate >=20 breaths per minute, SpO2 >93% on room air at sea level, heart rate >=90 beats per minute. (2) No clinical signs indicative of severe or critical COVID-19. B. Severe: (1) Clinical signs suggestive of severe systemic illness with COVID-19, such as respiratory rate >=30 breaths per minute, heart rate >=125 beats per minute, SpO2 less than or equal to (<=) 93% on room air at sea level or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) less than (<)300, heart rate >=125 beats per minute. (2) No criteria met for critical COVID-19
Has either normal renal function or mild or moderate renal impairment: estimated creatinine clearance >30 milliliters per minute (mL/min) on Day 1
Able to swallow the study drug (tablets)
Men whose sexual partners are women of childbearing potential (WOCBP) must agree to comply with one of the following contraception requirements from the time of first dose of study medication (Day 1) until at least 30 days after the last dose of study medication: (a) Vasectomy with documentation of azoospermia. (b) Sexual abstinence. (c) Male condom plus partner use of one of the contraceptive
WOCBP must agree to comply with one of the following contraception requirements from the time of first dose of study medication (Day 1) until at least 30 days after the last dose of study medication: (a) Sexual abstinence (b) Use of one of the contraceptive options (c) Vasectomy of male partner with documentation of azoospermia

You may not qualify if…

The participant, in the opinion of the investigator, is not likely to survive for >=48 hours beyond Day 1
Has a diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19 on Day 1
Has a documented current liver disease, or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones) at screening or on Day 1
Has a Child Pugh score >= C
Has a documented medical history of infection with human immunodeficiency virus or hepatitis A, B, or C at screening or on Day 1
Has a documented active infection with tuberculosis at screening or on Day 1
Has clinically significant ECG abnormalities at screening or on Day 1
Requires dialysis or is on any renal replacement therapies at screening or on Day 1
A female participant who is pregnant or planning to become pregnant during the study, breastfeeding, or has a positive pregnancy test at screening
Receiving alpha-blockers, combined alpha/beta blockers, antihistamines, or any drugs that will affect the levels of cytokines released due to immune stress
Has received any immunoglobulins within 6 months of screening or planned administration of any immunoglobulins during the screening and/or treatment periods
Has a known history of drug abuse within 6 months of study start that would interfere with the participant's participation in the study
Has a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, would contraindicate their participation
Has participated in and/or plan to participate in another clinical study
Will be transferred to another hospital which is not a study site within 72 hours
Cannot read and speak either English or Spanish
Other protocol defined Inclusion/Exclusion criteria may apply

Where it is running

Miami, Florida — Miami, Florida, United States
Palms of Pasadena Hospital, Saint Petersburg, Florida — St. Petersburg, Florida, United States
Theia Clinical Research, St. Petersburg, Florida — St. Petersburg, Florida, United States
Idaho Falls, Idaho — Idaho Falls, Idaho, United States
Winfield, Illinois — Winfield, Illinois, United States
Butte, Montana — Butte, Montana, United States
Tulsa, Oklahoma — Tulsa, Oklahoma, United States
Kingsport, Tennessee — Kingsport, Tennessee, United States
Amarillo, Texas — Amarillo, Texas, United States
Mesquite, Texas — Mesquite, Texas, United States

Full record on ClinicalTrials.gov

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