Clinical trial NCT04619706: Ultramicronized Palmitoylethanolamide (PEA) Treatment in Hospitalized Participants With COVID-19
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Keywords: SARS-CoV-2
Lead sponsor: Quantum Biopharma
Sponsor class: INDUSTRY
First posted: 2020-11-06
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Disease Progression at Day 28
timeFrame: Day 28
Secondary outcomes:
measure: Percentage of Participants With Disease Resolution at Day 28
timeFrame: Day 28
measure: Percentage of Participants Requiring Invasive Mechanical Ventilation or ExtraCorporeal Membrane Oxygenation (ECMO) or who are not Alive on Day 28
timeFrame: Day 28
measure: Change From Baseline in Oxygen use
timeFrame: Baseline, Day 15, and Day 28
measure: Change From Baseline in Saturation of Oxygen (SpO2) percent (%)
timeFrame: Baseline through Day 28
measure: Change From Baseline in Clinical Status Related to COVID-19
timeFrame: Baseline, Day 15, and Day 28
measure: Percentage of Participants who Die (Mortality Rate) at Day 28
timeFrame: Day 28
measure: Percentage of Participants Testing Negative for COVID-19 at Day 28
timeFrame: Day 28
measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From the signing of the informed consent to Day 60 (approximately 9 months)
measure: Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters, Electrocardiogram Findings and Physical Examination Findings
timeFrame: Baseline through Day 28
measure: Plasma Concentrations of FSD201
timeFrame: Day 1 and Day 14
measure: Maximum Observed Plasma Concentration (Cmax) of FSD201
timeFrame: Day 1 and Day 14
measure: Area Under the Concentration-Time Curve (AUC) of FSD201
timeFrame: Day 1 and Day 14
measure: Elimination Half-Life (t1/2)
timeFrame: Day 1 and Day 14
measure: Apparent Total Body Clearance (CL/F) of FSD201
timeFrame: Day 1 and Day 14
measure: Apparent Volume of Distribution (Vz/F) of FSD201
timeFrame: Day 1 and Day 14
measure: Average Observed Plasma Concentration at Steady State (Cav) of FSD201
timeFrame: Day 1 and Day 14
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami, Florida
state: Florida
city: Saint Petersburg
country: United States
facility: Palms of Pasadena Hospital, Saint Petersburg, Florida
state: Florida
city: Saint Petersburg
country: United States
facility: Theia Clinical Research, St. Petersburg, Florida
state: Florida
city: Idaho Falls
country: United States
facility: Idaho Falls, Idaho
state: Idaho
city: Winfield
country: United States
facility: Winfield, Illinois
state: Illinois
city: Butte
country: United States
facility: Butte, Montana
state: Montana
city: Tulsa
country: United States
facility: Tulsa, Oklahoma
state: Oklahoma
city: Kingsport
country: United States
facility: Kingsport, Tennessee
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo, Texas
state: Texas
city: Mesquite
country: United States
facility: Mesquite, Texas
state: Texas
Study officials:
References: