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

Sponsor
ParagonClinicals Inc.
Study ID
NCT07627815
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

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.
  • Dietary and Lifestyle Recommendations — OTHER
    Dietary and Lifestyle Recommendations specifically designed to enhance immune system function and reduce viral proliferation

Study Details

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.

Key Dates

First listed
Jun 4, 2026
Start date
May 20, 2026
Status verified
Jun 2026
Primary completion
Aug 26, 2026
Completion
Dec 26, 2026

Study Design

Enrollment
82 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Change in distance walked on the 6-minute walk test (6MWT) after 6 weeks of treatment. [ Time Frame: From enrollment to the end of treatment at 6 weeks ]

Central Contacts

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