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Tests treatment safety and results for Long COVID
Official title Evaluating the Safety and Efficacy of PNMR as Treatment for Long COVID
ClinicalTrials.gov ID: NCT07627815
What this study is testing
What is Paragon Novel Metabolic Regulator (PNMR)?
Paragon Novel Metabolic Regulator (PNMR) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for long covid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- The patient must meet all the following criteria to be enrolled 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...
- Long COVID diagnosis according to the WHO criteria, specifically the continuation or development of new symptoms three months after the initial...
You likely can't join 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.
- 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.
See the full eligibility criteria
- The patient must meet all the following criteria to be enrolled 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...
- 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...
- 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.
- 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.
- 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:
- 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
- Abnormal sensitivity to the toxic effects of vitamin D
- Sarcoidosis
- Hypervitaminosis D
The study team makes the final eligibility decision.
Where it's taking place
- Brampton, Ontario, Canada
- London, Ontario, Canada
- Mississauga, Ontario, Canada
- North York, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brampton, Ontario, Canada; London, Ontario, Canada; Mississauga, Ontario, Canada; North York, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.