[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637640":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":111,"collaborators":25,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":25,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":25,"enrollmentInfo":122,"targetDuration":25,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":49,"whyStopped":25,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"ParagonClinicals Inc.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"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 \u002Fday 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.\n\nPatients are instructed to take PNMR 5-20 minutes before eating, 3-6 capsules at a time, with water.\n\nPatients in Group 1 are also given specific dietary and lifestyle recommendations.\n\nPatients receiving PNMR will additionally be treated with SOC as per the regional guidelines and the decision of the treating physician.",[13,14],"Drug: Paragon Novel Metabolic Regulator (PNMR)","Other: Dietary and Lifestyle Recommendations",{"label":16,"type":10,"description":17,"interventionNames":18},"Group 2: Dietary and Lifetyle Recomendations + Standard of Care (SOC)","Patients in Group 2 will be given specific dietary and lifestyle recommendations.\n\nPatients receiving PNMR will additionally be treated with SOC as per the regional guidelines and the decision of the treating physician.",[14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","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.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"OTHER","Dietary and Lifestyle Recommendations","Dietary and Lifestyle Recommendations specifically designed to enhance immune system function and reduce viral proliferation",[9,16],[32],{"name":33,"affiliation":34,"role":35},"Sam Bock, BA Environmental Science","ParagonClinicals Inc CEO \u002F CSO","STUDY_DIRECTOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Samuel H. O. Bock \u002F CSO, BA Environmental Science","CONTACT","514 998-3935","sbock@paragonsciences.com",{"name":43,"role":39,"phone":44,"phoneExt":25,"email":45},"John S Sampalis, PHD Epidemiology","514 934-6116","jsampalis@jssresearch.com",[47,70,85,100],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Cardio Health","RECRUITING","Brampton","Ontario","L6Y 6H4","Canada","CA",{"type":56,"coordinates":57},"Point",[58,59],-79.76633,43.68341,{"lat":59,"lon":58},[62,67],{"name":63,"role":39,"phone":64,"phoneExt":65,"email":66},"Amarjot Bhatia","226-797-5974","12301","amarjot@cardio-health.ca",{"name":68,"role":69,"phone":25,"phoneExt":25,"email":25},"Fairoze Poonah, MD","PRINCIPAL_INVESTIGATOR",{"facility":48,"status":49,"city":71,"state":51,"zip":72,"country":53,"countryCode":54,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"London","N6G 5C2",{"type":56,"coordinates":74},[75,76],-81.23304,42.98339,{"lat":76,"lon":75},[79,83],{"name":80,"role":39,"phone":81,"phoneExt":25,"email":82},"Naheed Rizvi, MD","226-783-4649","naheed@cardio-health.ca",{"name":84,"role":69,"phone":25,"phoneExt":25,"email":25},"Marius Naghiu, MD",{"facility":48,"status":49,"city":86,"state":51,"zip":87,"country":53,"countryCode":54,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Mississauga","L5M 2S6",{"type":56,"coordinates":89},[90,91],-79.6583,43.5789,{"lat":91,"lon":90},[94,98],{"name":95,"role":39,"phone":64,"phoneExt":96,"email":97},"Jamie Kwon","12300","jamie@cardio-health.ca",{"name":99,"role":69,"phone":25,"phoneExt":25,"email":25},"Sadaf Sarwar, MD",{"facility":48,"status":49,"city":101,"state":51,"zip":102,"country":53,"countryCode":54,"cosmosGeoPoint":25,"geoPoint":25,"contacts":103},"North York","M3N 2K1",[104,109],{"name":105,"role":39,"phone":106,"phoneExt":107,"email":108},"Mala Singh","905-882-4848","12296","mala@cardio-health.ca",{"name":110,"role":69,"phone":25,"phoneExt":25,"email":25},"Emma Benedict, MD",{"type":112,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100637640","phase-2-evaluating-the-safety-and-efficacy-of-pnmr-as-treatment-for-long-covid-100637640",false,"NCT07627815","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","Inclusion Criteria: The patient must meet all the following criteria to be enrolled in the study:\n\n1. ≥19 years of age.\n2. Negative COVID-19 test for a minimum of four (4) weeks prior to enrollment in the study.\n3. 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.\n4. 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.\n5. 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.\n\n   Note: If participant become pregnant during the study, they must stop taking the study products immediately and inform the study investigator.\n6. 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.\n7. Patient agrees not to use medications affecting directly (or potentially) the objectives of the study such as fatigue and cognitive function during the study.\n8. Willing to adhere to the study diet and exercise recommendations to the best of the patient's ability.\n9. Willing to complete the 6MWT.\n10. Willing to complete the patient self-administered questionnaires and diaries.\n11. 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\u002Fauthorized representatives.\n\nExclusion Criteria:\n\n1. Subject is a female who is breastfeeding or pregnant or trying to conceive.\n2. Subject with a vegetarian diet or not able to follow the dietary guidelines.\n3. Known hypersensitivity to PNMR or its ingredients.\n4. Participating in other drug clinical trials (participation in COVID-19 antiviral trials may be permitted if approved by sponsor).\n5. Any condition that in the opinion of the investigator participation in the trial increases the risk to the patient.\n6. 4 weeks or more of consecutive daily supplement use of 5000 IUs Vitamin D \u002F day and\u002For 50mg Zinc (without copper) \u002F day within 4 weeks of Day 0.\n7. Use of any medications or treatments for which treatment with PNMR is counter-indicated.\n8. Subject is not able to swallow a larger number of capsules.\n9. Any condition that in the opinion of the investigator would confound the study results or would prevent the patient to complete the study.\n10. Any patient for whom vitamin D3 (cholecalciferol) is contraindicated per the following patient situations:\n\n    1. Hypersensitivity to vitamin D, any of its analogues and derivatives or to any ingredient in the formulation\n    2. Hypercalcemia and\u002For hypercalciuria\n    3. Nephrolithiasis (renal calculi)\n    4. Severe renal impairment (eGFR \\\u003C30)\n    5. Malabsorption syndrome\n    6. Abnormal sensitivity to the toxic effects of vitamin D\n    7. Sarcoidosis\n    8. Hypervitaminosis D","ALL","19 Years",{"count":123,"type":124},82,"ESTIMATED","INTERVENTIONAL",[127],"PHASE2","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.\n\nPatients will be assessed in the clinic at screening\u002Fbaseline, 3 and 6 weeks while on treatment, and by telephone at 4 weeks post-treatment.\n\nAll 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.",[130],"Long COVID",[132,133,134,135],"Covid-19","Brain Fog","Chronic Fatigue","Post Exertional Malaise","2026-06-02",{"date":138,"type":139},"2026-06-04","ACTUAL",{"date":141,"type":139},"2026-05-20",{"date":143,"type":124},"2026-12-26",{"name":5,"class":6},4]