Evaluating the Safety and Efficacy of PNMR as Treatment for Long COVID

NCT07627815 | Recruiting Phase 2

• 1 other identifier: PRG-PNMR-LC001
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Long COVID

Keywords

Covid-19; Brain Fog; Chronic Fatigue; Post Exertional Malaise

Outcome Measures

Primary Outcomes (1)

• Change in distance walked on the 6-minute walk test (6MWT) after 6 weeks of treatment.

  Patient baseline is first assessed at Day 0 upon screening, and then retested after 6 weeks of treatment.

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (8)

• Change in distance walked on the 6MWT after 3 weeks of treatment.

  From enrollment to the completion of 3 weeks initial treatment.

• Proportion of patients achieving an improvement of 30 meters or more on the 6MWT by 3 and 6 weeks on treatment.

  From enrollment to measurements made at 3 and 6 weeks

• Time to achieving an improvement of 30 m or more on the 6MWT by 6 weeks on treatment.

  From enrollment to measurements made at either 3 or 6 week if achieved

• Change in patient-reported assessment of fatigue on a 100 mm visual analogue scale (VAS) at 3 and 6 weeks on treatment.

  From enrollment assessment to assessments made at 3 and 6 weeks

• Change in patient-reported assessment of brain fog duration at 3 and 6 weeks on treatment.

  From enrollment assessment to assessments made at 3 and 6 weeks

Other Outcomes (1)

• Number of treatment-emergent adverse events (TEAEs) and serious TEAEs.

  Realized from enrollment to completion of treatment at 6 weeks

Study Arms (2)

Group 1: PNMR + Dietary and Lifetyle Recomendations + Standard of Care (SOC)

EXPERIMENTAL

Patients in Group 1 are instructed to take 2 PNMR packs on Day 1 and evaluate and adjust their daily PNMR dosage from Day 2 to Day 42 of their 6-week treatment period up to a maximum of 6 packs per day based on the presence of long COVID symptoms. Patients lower the dosage by 1 pack /day based upon signals showing the body is healing (and has replenished its depleted sulfur protein nutrient stores - required for energy production and healing), as seen with a temporary release of sulfur-smelling flatulence, or rarely unpleasant dreams, if the patient no longer needs as much medicine. Patients maintain a minimum dosage of no less than 1 pack per 2 days. Patients are instructed to take PNMR 5-20 minutes before eating, 3-6 capsules at a time, with water. Patients in Group 1 are also given specific dietary and lifestyle recommendations. Patients receiving PNMR will additionally be treated with SOC as per the regional guidelines and the decision of the treating physician.

Drug: Paragon Novel Metabolic Regulator (PNMR); Other: Dietary and Lifestyle Recommendations

Group 2: Dietary and Lifetyle Recomendations + Standard of Care (SOC)

EXPERIMENTAL

Patients in Group 2 will be given specific dietary and lifestyle recommendations. Patients receiving PNMR will additionally be treated with SOC as per the regional guidelines and the decision of the treating physician.

Other: Dietary and Lifestyle Recommendations

Interventions

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.

Group 1: PNMR + Dietary and Lifetyle Recomendations + Standard of Care (SOC)

Dietary and Lifestyle Recommendations OTHER

Dietary and Lifestyle Recommendations specifically designed to enhance immune system function and reduce viral proliferation

Group 1: PNMR + Dietary and Lifetyle Recomendations + Standard of Care (SOC); Group 2: Dietary and Lifetyle Recomendations + Standard of Care (SOC)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.
• 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 investigator.
• 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 form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives.

You may not qualify if:

• Subject is a female who is breastfeeding or pregnant or trying to conceive.
• Subject with a vegetarian diet or not able to follow the dietary guidelines.
• Known hypersensitivity to PNMR or its ingredients.
• Participating in other drug clinical trials (participation in COVID-19 antiviral trials may be permitted if approved by sponsor).
• Any condition that in the opinion of the investigator participation in the trial increases the risk to the patient.
• 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:
• Hypersensitivity to vitamin D, any of its analogues and derivatives or to any ingredient in the formulation
• Hypercalcemia and/or hypercalciuria
• Nephrolithiasis (renal calculi)
• Severe renal impairment (eGFR \<30)
• Malabsorption syndrome

Sponsors & Collaborators

• ParagonClinicals Inc.: lead

Study Sites (4)

Cardio Health

Brampton, Ontario, L6Y 6H4, Canada

RECRUITING

Cardio Health

London, Ontario, N6G 5C2, Canada

RECRUITING

Cardio Health

Mississauga, Ontario, L5M 2S6, Canada

RECRUITING

Cardio Health

North York, Ontario, M3N 2K1, Canada

RECRUITING

Related Publications (3)

• Al-Aly Z, Davis H, McCorkell L, Soares L, Wulf-Hanson S, Iwasaki A, Topol EJ. Long COVID science, research and policy. Nat Med. 2024 Aug;30(8):2148-2164. doi: 10.1038/s41591-024-03173-6. Epub 2024 Aug 9.

  PMID: 39122965 BACKGROUND

• Castanares-Zapatero D, Chalon P, Kohn L, Dauvrin M, Detollenaere J, Maertens de Noordhout C, Primus-de Jong C, Cleemput I, Van den Heede K. Pathophysiology and mechanism of long COVID: a comprehensive review. Ann Med. 2022 Dec;54(1):1473-1487. doi: 10.1080/07853890.2022.2076901.

  PMID: 35594336 BACKGROUND

• Davis HE, McCorkell L, Vogel JM, Topol EJ. Long COVID: major findings, mechanisms and recommendations. Nat Rev Microbiol. 2023 Mar;21(3):133-146. doi: 10.1038/s41579-022-00846-2. Epub 2023 Jan 13.

  PMID: 36639608 BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19; Mental Fatigue

Interventions

Diet

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatigue; Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Sam Bock, BA Environmental Science

  ParagonClinicals Inc CEO / CSO

  STUDY DIRECTOR

Central Study Contacts

Samuel H. O. Bock / CSO, BA Environmental Science

CONTACT

514 998-3935; sbock@paragonsciences.com

John S Sampalis, PHD Epidemiology

CONTACT

514 934-6116; jsampalis@jssresearch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 4, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): August 26, 2026
• Study Completion (Estimated): December 26, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 3 years after the publication of results

Locations

CA (4)