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

FSD Pharma

Status and phase

Terminated

Phase 2

Conditions

COVID-19

Treatments

Other: Standard of Care for Covid-19

Drug: FSD201

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04619706

FSD201-03

Details and patient eligibility

About

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.

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

53 participants in 3 patient groups, including a placebo group

Arm A: FSD201 600 mg

Experimental group

Description:

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.

Treatment:

Drug: FSD201

Other: Standard of Care for Covid-19

Drug: Placebo

Arm B: FSD201 1200 mg

Experimental group

Description:

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

Treatment:

Drug: FSD201

Other: Standard of Care for Covid-19

Arm C: Placebo