COVID-19Phase 2NCT04619706
Ultramicronized Palmitoylethanolamide (PEA) Treatment in Hospitalized Participants With COVID-19
A Phase 2 study testing FSD201 in people with COVID-19, run by Quantum Biopharma at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- FSD201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 10 sitesUnited States
- Study dates
- 14 Dec 2020to 24 Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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 locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Amarillo, Texas
Amarillo, Texas, 79109
Butte, Montana
Butte, Montana, 59701
Idaho Falls, Idaho
Idaho Falls, Idaho, 83404
Kingsport, Tennessee
Kingsport, Tennessee, 37660
Mesquite, Texas
Mesquite, Texas, 75149
Miami, Florida
Miami, Florida, 33155
Palms of Pasadena Hospital, Saint Petersburg, Florida
St. Petersburg, Florida, 33707
Theia Clinical Research, St. Petersburg, Florida
St. Petersburg, Florida, 33707
Tulsa, Oklahoma
Tulsa, Oklahoma, 74104
Winfield, Illinois
Winfield, Illinois, 60190
About this study
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
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
- Being tested
- FSD201, Placebo, Standard of Care for Covid-19
- Keywords
- SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSD201Drug
Also called ultramicronized palmitoylethanolamide (PEA)
Tablets for oral administration.
PlaceboDrug
Placebo tablets matched to FSD201 for oral administration.
Standard of Care for Covid-19Other
Standard of care for Covid-19 as determined by site PI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Placebo; Other: Standard of Care for Covid-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 28
Secondary outcomes (16)
Percentage of Participants With Disease Resolution at Day 28
Disease resolution will be defined as participants alive and not requiring supplemental oxygen (at home or in the hospital).
Measured: Day 28
Percentage of Participants Requiring Invasive Mechanical Ventilation or ExtraCorporeal Membrane Oxygenation (ECMO) or who are not Alive on Day 28
Measured: Day 28
Change From Baseline in Oxygen use
Oxygen use will be assessed by change in the type of oxygen use between the following categories: no oxygen, supplemental oxygen, non-invasive mechanical ventilation or high-flow oxygen, invasive mechanical ventilation/ECMO.
Measured: Baseline, Day 15, and Day 28
Change From Baseline in Saturation of Oxygen (SpO2) percent (%)
Measured: Baseline through Day 28
Change From Baseline in Clinical Status Related to COVID-19
Clinical status will be measured with the 9-point ordinal scale ranging (1-9; 1 being death and 9 being not hospitalized, not requiring supplemental home oxygen, and no limitations on activities).
Measured: Baseline, Day 15, and Day 28
Percentage of Participants who Die (Mortality Rate) at Day 28
Mortality rate will be defined as the percentage of participants who die.
Measured: Day 28
Percentage of Participants Testing Negative for COVID-19 at Day 28
COVID-19 testing by standard standard reverse transcription-polymerase chain reaction (RT-PCR) assay or equivalent test.
Measured: Day 28
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs will be summarized and reported by seriousness, severity, relationship to the study medication, outcome, and duration.
Measured: From the signing of the informed consent to Day 60 (approximately 9 months)
Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters, Electrocardiogram Findings and Physical Examination Findings
The number of participants with clinically significant changes in vital signs, laboratory parameters and electrocardiogram findings, and physical findings will be reported.
Measured: Baseline through Day 28
Plasma Concentrations of FSD201
Plasma concentrations will be measured in participants who give optional consent will be collected relative to the first dose on Day 1 and the first dose on Day 14. Samples on Day 1 and Day 14 will be collected predose (within 10 minutes before the first daily dose) and post dose at 2 hours (±30 minutes), 12 hours (±30 minutes) (before the evening dose), and 24 hours (±30 minutes)(before the next morning dose).
Measured: Day 1 and Day 14
Maximum Observed Plasma Concentration (Cmax) of FSD201
Cmax is defined as maximum observed plasma concentration.
Measured: Day 1 and Day 14
Area Under the Concentration-Time Curve (AUC) of FSD201
Area under the concentration-time curve (AUC).
Measured: Day 1 and Day 14
Elimination Half-Life (t1/2)
Elimination half-life (t1/2) of FSD201.
Measured: Day 1 and Day 14
Apparent Total Body Clearance (CL/F) of FSD201
CL/F is the apparent total body clearance of FSD201 in plasma.
Measured: Day 1 and Day 14
Apparent Volume of Distribution (Vz/F) of FSD201
Vz/F is the apparent volume of distribution of FSD201 in plasma.
Measured: Day 1 and Day 14
Average Observed Plasma Concentration at Steady State (Cav) of FSD201
Cav is average plasma concentration over a dosing interval.
Measured: Day 1 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start14 Dec 2020
- Primary completion24 Aug 2021
- Study completion24 Aug 2021
Why it stopped: Difficulties recruiting new subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quantum Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619706
- Sponsor's protocol ID
- FSD201-03
- Status last verified
- Nov 2022
- First submitted
- 5 Nov 2020
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04619706
- Acronym / sponsor ID
- FSD201-03
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties recruiting new subjects
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Quantum BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: FSD201 600 mg | Experimental | Drug: FSD201, Drug: Placebo, Other: Standard of Care for Covid-19Participants 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. |
| Arm B: FSD201 1200 mg | Experimental | Drug: FSD201, Other: Standard of Care for Covid-19Participants will receive 1200 mg (2x600 mg) tablets FSD201 BID orally from Day 1 to Day 14. |
| Arm C: Placebo | Placebo comparator | Drug: Placebo, Other: Standard of Care for Covid-19Participants will receive placebo matched to 600 mg FSD201 tablets (2xplacebo tablets) from Day 1 to Day 14. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FSD201Also: ultramicronized palmitoylethanolamide (PEA)Tablets for oral administration. | Drug | Arm A: FSD201 600 mg, Arm B: FSD201 1200 mg |
| PlaceboPlacebo tablets matched to FSD201 for oral administration. | Drug | Arm A: FSD201 600 mg, Arm C: Placebo |
| Standard of Care for Covid-19Standard of care for Covid-19 as determined by site PI | Other | Arm A: FSD201 600 mg, Arm B: FSD201 1200 mg, Arm C: Placebo |
Primary outcome
Percentage of Participants With Disease Progression at Day 28
Time frame: 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).
16 secondary outcomes
Percentage of Participants With Disease Resolution at Day 28
Time frame: Day 28
Percentage of Participants Requiring Invasive Mechanical Ventilation or ExtraCorporeal Membrane Oxygenation (ECMO) or who are not Alive on Day 28
Time frame: Day 28
Change From Baseline in Oxygen use
Time frame: Baseline, Day 15, and Day 28
Change From Baseline in Saturation of Oxygen (SpO2) percent (%)
Time frame: Baseline through Day 28
Change From Baseline in Clinical Status Related to COVID-19
Time frame: Baseline, Day 15, and Day 28
Percentage of Participants who Die (Mortality Rate) at Day 28
Time frame: Day 28
Percentage of Participants Testing Negative for COVID-19 at Day 28
Time frame: Day 28
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the signing of the informed consent to Day 60 (approximately 9 months)
Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters, Electrocardiogram Findings and Physical Examination Findings
Time frame: Baseline through Day 28
Plasma Concentrations of FSD201
Time frame: Day 1 and Day 14
Maximum Observed Plasma Concentration (Cmax) of FSD201
Time frame: Day 1 and Day 14
Area Under the Concentration-Time Curve (AUC) of FSD201
Time frame: Day 1 and Day 14
Elimination Half-Life (t1/2)
Time frame: Day 1 and Day 14
Apparent Total Body Clearance (CL/F) of FSD201
Time frame: Day 1 and Day 14
Apparent Volume of Distribution (Vz/F) of FSD201
Time frame: Day 1 and Day 14
Average Observed Plasma Concentration at Steady State (Cav) of FSD201
Time frame: Day 1 and Day 14
Results and safety
The study was stopped early (reason given: Difficulties recruiting new subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FSD201 in people with COVID-19, run by Quantum Biopharma at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties recruiting new subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Disease Progression at Day 28 (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.