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

ConditionLong COVID

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age19+

SponsorParagonClinicals Inc.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

82 Participants

are divided into 2 treatment groups

Group A: Group 1: PNMR + Dietary and Lifetyle Recomendations + Standard of Care (SOC)Experimental treatment 2 interventions

Group B: Group 2: Dietary and Lifetyle Recomendations + Standard of Care (SOC)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

From enrollment to the end of treatment at 6 weeks

Secondary outcomes

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

Time frame

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.

Time frame

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.

Time frame

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.

Fatigue Severity over the last 7 days, reported on a 100 mm Visual Analogue Scale: 0 - 100, higher score means a worse outcome

Time frame

From enrollment assessment to assessments made at 3 and 6 weeks

Other outcomes

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

Time frame

Realized from enrollment to completion of treatment at 6 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ParagonClinicals Inc.

Lead sponsor

Source ClinicalTrials.gov

Apply now