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
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
Treatments tested in this trial
- Paragon Novel Metabolic Regulator (PNMR)
- Dietary and Lifestyle Recommendations
Treatment groups
82 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov