RE:Hopefully you will be able to read thisI'm sure you know, this news came out a few days ago and the market responded as it should. Poorly. Dr R just did a video where he said they only have enough money to fi ish phase 2a. That means anything further will have to be through dilution. FSD is to low to dilute, it will put them below a $1.00 on the Nasdaq. How do they deal with that, they do another massive RS then dilute. It's the only way to raise funds without government grants. The markets know this. The math is there. Every dilution is share value decrease. They don't have the cushion for the decrease. Do you know how much they have burned through this year just getting phase 2a just to begin? From selling Cannara hightide and other assets to raising around 50 million if not more , I would have to dig it all up to be accurate. They may or may not sell the building for around 15 million which will get them a small lifeline but not much. That's not even half of a basic phase trials. This pipedream is no longer anything other than suck retail investors for as much as they can then RS. That's it. AGP only needs a nominal boost to make millions so they don't care, the boost will come, once or twice. This is as dead as Nortel networks right about now. This is not investor advice just total opinion. If someone wants to tell me where FSD will get the next 75-100 mill to finish the other trials never mind cost to bring this to market please enlighten me. I would love to recoup even 50% of my money at this point.
Crazydavid wrote: Ultramicronized Palmitoylethanolamide (PEA) Treatment in Hospitalized Participants With COVID-19
| | The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04619706 |
Recruitment Status : Not yet recruiting First Posted : November 6, 2020 Last Update Posted : November 6, 2020 |
Sponsor:
Information provided by (Responsible Party):
FSD Pharma, Inc.
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.
| COVID-19 | Drug: FSD201Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 350 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Estimated Study Start Date : | November 15, 2020 |
| Estimated Primary Completion Date : | August 14, 2021 |
| Estimated Study Completion Date : | December 5, 2021 |
| Experimental: Arm A: FSD201 600 mg 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 Tablets for oral administration. Other Name: ultramicronized palmitoylethanolamide (PEA)
Drug: Placebo Placebo tablets matched to FSD201 for oral administration. |
| Experimental: Arm B: FSD201 1200 mg Participants will receive 1200 mg (2x600 mg) tablets FSD201 BID orally from Day 1 to Day 14. | Drug: FSD201 Tablets for oral administration. Other Name: ultramicronized palmitoylethanolamide (PEA) |
| Placebo Comparator: Arm C: Placebo Participants will receive placebo matched to 600 mg FSD201 tablets (2xplacebo tablets) from Day 1 to Day 14. | Drug: Placebo Placebo tablets matched to FSD201 for oral administration. |
Primary Outcome Measures :
- 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).
Secondary Outcome Measures :
- Percentage of Participants With Disease Resolution at Day 28 [ Time Frame: Day 28 ]
Disease resolution will be defined as participants alive and not requiring supplemental oxygen (at home or in the hospital).
- 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 ]
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.
- 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 ]
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).
- Percentage of Participants who Die (Mortality Rate) at Day 28 [ Time Frame: Day 28 ]
Mortality rate will be defined as the percentage of participants who die.
- Percentage of Participants Testing Negative for COVID-19 at Day 28 [ Time Frame: Day 28 ]
COVID-19 testing by standard standard reverse transcription-polymerase chain reaction (RT-PCR) assay or equivalent test.
- 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 AEs and SAEs will be summarized and reported by seriousness, severity, relationship to the study medication, outcome, and duration.
- Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters, Electrocardiogram Findings and Physical Examination Findings [ Time Frame: Baseline through Day 28 ]
The number of participants with clinically significant changes in vital signs, laboratory parameters and electrocardiogram findings, and physical findings will be reported.
- Plasma Concentrations of FSD201 [ Time Frame: Day 1 and Day 14 ]
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).
- Maximum Observed Plasma Concentration (Cmax) of FSD201 [ Time Frame: Day 1 and Day 14 ]
Cmax is defined as maximum observed plasma concentration.
- Area Under the Concentration-Time Curve (AUC) of FSD201 [ Time Frame: Day 1 and Day 14 ]
Area under the concentration-time curve (AUC).
- Elimination Half-Life (t1/2) [ Time Frame: Day 1 and Day 14 ]
Elimination half-life (t1/2) of FSD201.
- Apparent Total Body Clearance (CL/F) of FSD201 [ Time Frame: Day 1 and Day 14 ]
CL/F is the apparent total body clearance of FSD201 in plasma.
- Apparent Volume of Distribution (Vz/F) of FSD201 [ Time Frame: Day 1 and Day 14 ]
Vz/F is the apparent volume of distribution of FSD201 in plasma.
- Average Observed Plasma Concentration at Steady State (Cav) of FSD201 [ Time Frame: Day 1 and Day 14 ]
Cav is average plasma concentration over a dosing interval.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04619706
FSD Pharma, Inc.
| Responsible Party: | FSD Pharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT04619706 History of Changes |
| Other Study ID Numbers: | FSD201-03 |
| First Posted: | November 6, 2020 Key Record Dates |
| Last Update Posted: | November 6, 2020 |
| Last Verified: | November 2020 |
| Individual Participant Data (IPD) Sharing Statement: |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by FSD Pharma, Inc.:
Additional relevant MeSH terms:
Palmidrol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents | Antiviral Agents
Anti-Infective Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists |