Comparing Paragon Novel Metabolic Regulator with Dietary and Lifestyle Recommendations for long COVID
Official title: Evaluating the Safety and Efficacy of PNMR as Treatment for Long COVID
Phase II, Proof of Concept, Open-Label, Randomized-Controlled Trial Evaluating the Efficacy and Safety of PARAGON Novel Metabolic Regulator Formula (PNMR) in the Management of Long COVID
- Phase 2
- 2 groups
- Sites in Brampton, London and 1 more city
- Recruiting
Interventions
- Medication
Paragon Novel Metabolic Regulator (PNMR)
Research shows human cell systems maintain significant cellular storage levels of a wide range of critical metabolites supporting enzymes driving mitochondrial and immune system function and healing, all of which can be depleted by serious illness. Such cell systems and components (including the cytosol, mitochondria, metabolic pathways within cells, white blood cells, antibodies, antimicrobial peptides, enzymes, and other compounds) require specific concentrations of specific amino and fatty acids - and corresponding concentrations of a wide range of specific metabolites - that together enable their continuous metabolism within those cell systems. The PNMR capsules (provided in 1 - 6 packets per day) are designed to quickly restore optimum and balanced cellular storage levels of those critical metabolites driving the balanced intracellular enzyme activity and metabolism required to maintain mitochondrial and immune system function, healing, and homeostatic regulation.
- Other intervention
Dietary and Lifestyle Recommendations
Dietary and Lifestyle Recommendations specifically designed to enhance immune system function and reduce viral proliferation
Canadian Sites (4)
4 of 4 recruiting
- Recruiting
Cardio Health
Brampton, Ontario
- Recruiting
Cardio Health
London, Ontario
- Recruiting
Cardio Health
Mississauga, Ontario
- Recruiting
Cardio Health
North York, Ontario
Eligibility Criteria
See who this study is looking for31 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +The patient must meet all the following criteria to be enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in the study:
- +≥19 years of age.
- +Negative COVID-19 test for a minimum of four (4) weeks prior to enrollment in the study.
- +Confirmed COVID-19 diagnosis by Polymerase chain reaction (PCR) test, antibody test, or clinical diagnosis more than four (4) weeks prior to enrollment in the study.
- +Long COVID diagnosis according to the WHO criteria, specifically the continuation or development of new symptoms three months after the initial SARS-COV-2 infection, with these symptoms lasting for more than two months with no other explanation.
- +Patient agrees to stop taking any over the counter supplements, vitamins, or natural products as well as any of the prohibited medications during the study.
- +Patient agrees not to use medications affecting directly (or potentially) the objectives of the study such as fatigue and cognitive function during the study.
- +Willing to adhere to the study diet and exercise recommendations to the best of the patient's ability.
- +Willing to complete the 6MWT.
- +Willing to complete the patient self-administered questionnaires and diaries.
- +Signed informed consent formInformed consentThe process of being told what taking part involves, then choosing freely.Read more → by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives.
- +For women of childbearing potential involved in any sexual intercourse that could lead to pregnancy: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during the study period. Approved contraceptive methods include contraceptive pills or patches, hormonal implants, intrauterine device (IUD), diaphragm or cervical cap with spermicide, and condos with spermicide.
- +Note: If participant become pregnant during the study, they must stop taking the study products immediately and inform the study investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
Exclusion
- −Known hypersensitivity to PNMR or its ingredients.
- −Hypersensitivity to vitamin D, any of its analogues and derivatives or to any ingredient in the formulation
- −Subject with a vegetarian diet or not able to follow the dietary guidelines.
- −Participating in other drug clinical trials (participation in COVID-19 antiviral trials may be permitted if approved by sponsorSponsorThe organisation responsible for the study overall.Read more →).
- −Any condition that in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → participation in the trial increases the risk to the patient.
- −4 weeks or more of consecutive daily supplement use of 5000 IUs Vitamin D / day and/or 50mg Zinc (without copper) / day within 4 weeks of Day 0.
- −Use of any medications or treatments for which treatment with PNMR is counter-indicated.
- −Subject is not able to swallow a larger number of capsules.
- −Any condition that in the opinion of the investigator would confound the study results or would prevent the patient to complete the study.
- −Any patient for whom vitamin D3 (cholecalciferol) is contraindicated per the following patient situations:
- −Hypercalcemia and/or hypercalciuria
- −Nephrolithiasis (renal calculi)
- −Severe renal impairment (eGFR \<30)
- −Malabsorption syndrome
- −Abnormal sensitivity to the toxic effects of vitamin D
- −Sarcoidosis
- −Hypervitaminosis D
- −Subject is a female who is breastfeeding or pregnant or trying to conceive.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives one or more of: Paragon Novel Metabolic Regulator (PNMR) and Dietary and Lifestyle Recommendations.
Registry label: A: Group 1: PNMR + Dietary and Lifetyle Recomendations + Standard of Care (SOC)
Group B receives Dietary and Lifestyle Recommendations.
Registry label: B: Group 2: Dietary and Lifetyle Recomendations + Standard of Care (SOC)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 19 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 82 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → to the end of treatment at 6 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change in distance walked on the 6-minute walk test (6MWT) after 6 weeks of treatment — measured over From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → to the end of treatment at 6 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07627815 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Paragon Novel Metabolic Regulator (PNMR)Drug
Research shows human cell systems maintain significant cellular storage levels of a wide range of critical metabolites supporting enzymes driving mitochondrial and immune system function and healing, all of which can be depleted by serious illness. Such cell systems and components (including the cytosol, mitochondria, metabolic pathways within cells, white blood cells, antibodies, antimicrobial peptides, enzymes, and other compounds) require specific concentrations of specific amino and fatty acids - and corresponding concentrations of a wide range of specific metabolites - that together enable their continuous metabolism within those cell systems. The PNMR capsules (provided in 1 - 6 packets per day) are designed to quickly restore optimum and balanced cellular storage levels of those critical metabolites driving the balanced intracellular enzyme activity and metabolism required to maintain mitochondrial and immune system function, healing, and homeostatic regulation.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Dietary and Lifestyle RecommendationsOther
Dietary and Lifestyle Recommendations specifically designed to enhance immune system function and reduce viral proliferation
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 19 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 19 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → to the end of treatment at 6 weeks.
The study as a whole is currently expected to finish around 2026-12-26.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 82 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: Brampton, Ontario, Canada; London, Ontario, Canada; Mississauga, Ontario, Canada; North York, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This will be a six-week, randomized, parallel, two group, open-label design. Patients will be treated with Paragon Novel Metabolic Regulator (PNMR) + standard of care (SOC) or SOC alone for 6 weeks for the treatment of Long COVID. All patients will also be provided with with Dietary \& Lifestyle recommendations specifically designed to enhance immune system function and reduce viral proliferation. Patients will be assessed in the clinic at screening/baseline, 3 and 6 weeks while on treatment, and by telephone at 4 weeks post-treatment. All patients will be asked to fill in a diary to record their daily treatment dosage when being treated with PNMR + SOC or with SOC alone. Primary objective: To evaluate the efficacy of PNMR + (SOC) vs. SOC in the treatment and management of patients with long COVID.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.