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

NCT04619706 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: FSD201-03
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 10

Brief 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

COVID-19

Keywords

SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Disease Progression at Day 28

  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).

  Day 28

Secondary Outcomes (16)

• Percentage of Participants With Disease Resolution at Day 28

  Day 28

• Percentage of Participants Requiring Invasive Mechanical Ventilation or ExtraCorporeal Membrane Oxygenation (ECMO) or who are not Alive on Day 28

  Day 28

• Change From Baseline in Oxygen use

  Baseline, Day 15, and Day 28

• Change From Baseline in Saturation of Oxygen (SpO2) percent (%)

  Baseline through Day 28

• Change From Baseline in Clinical Status Related to COVID-19

  Baseline, Day 15, and Day 28

Study Arms (3)

Arm A: FSD201 600 mg

EXPERIMENTAL

Participants will receive 600 milligrams (mg) FSD201 tablet twice daily (BID) orally along with the placebo matched to 600 mg FSD201 tablet from Day 1 to Day 14.

Drug: FSD201; Drug: Placebo; Other: Standard of Care for Covid-19

Arm B: FSD201 1200 mg

EXPERIMENTAL

Participants will receive 1200 mg (2x600 mg) tablets FSD201 BID orally from Day 1 to Day 14.

Drug: FSD201; Other: Standard of Care for Covid-19

Arm C: Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to 600 mg FSD201 tablets (2xplacebo tablets) from Day 1 to Day 14.

Drug: Placebo; Other: Standard of Care for Covid-19

Interventions

FSD201 DRUG

Tablets for oral administration.

Also known as: ultramicronized palmitoylethanolamide (PEA)

Arm A: FSD201 600 mg; Arm B: FSD201 1200 mg

Placebo DRUG

Placebo tablets matched to FSD201 for oral administration.

Arm A: FSD201 600 mg; Arm C: Placebo

Standard of Care for Covid-19 OTHER

Standard of care for Covid-19 as determined by site PI

Arm A: FSD201 600 mg; Arm B: FSD201 1200 mg; Arm C: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Quantum Biopharma: lead

Study Sites (10)

Miami, Florida

Miami, Florida, 33155, United States

Location

Palms of Pasadena Hospital, Saint Petersburg, Florida

St. Petersburg, Florida, 33707, United States

Location

Theia Clinical Research, St. Petersburg, Florida

St. Petersburg, Florida, 33707, United States

Location

Idaho Falls, Idaho

Idaho Falls, Idaho, 83404, United States

Location

Winfield, Illinois

Winfield, Illinois, 60190, United States

Location

Butte, Montana

Butte, Montana, 59701, United States

Location

Tulsa, Oklahoma

Tulsa, Oklahoma, 74104, United States

Location

Kingsport, Tennessee

Kingsport, Tennessee, 37660, United States

Location

Amarillo, Texas

Amarillo, Texas, 79109, United States

Location

Mesquite, Texas

Mesquite, Texas, 75149, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 6, 2020
• Study Start: December 14, 2020
• Primary Completion: August 24, 2021
• Study Completion: August 24, 2021
• Last Updated: December 5, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)