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Study to Evaluate the Effect of Nicotinamide Mononucleotide (NMN) As an Adjuvant to Standard of Care (SOC) On Fatigue Associated With COVID-19 Infection | Clinical Trials | Clareo Health

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Study to Evaluate the Effect of Nicotinamide Mononucleotide (NMN) As an Adjuvant to Standard of Care (SOC) On Fatigue Associated With COVID-19 Infection

A Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Effect of Nicotinamide Mononucleotide (NMN) As an Adjuvant to Standard of Care (SOC) On Fatigue Associated With COVID-19 Infection

NCT05175768•Vedic Lifesciences Pvt. Ltd.

View on ClinicalTrials.gov

Summary

A Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Effect of Nicotinamide Mononucleotide (NMN) As an Adjuvant to Standard of Care (SOC) On Fatigue Associated with COVID-19 Infection

Eligibility

Age

40 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Individuals ≥ 40 years of age at time of enrolment.
•2. laboratory-confirmed diagnosis of SARS-CoV-2 infection as determined by RT-PCR/ Rapid antigen test/ any other test.
•3. Hospitalized within 2 days from screening and exhibiting tachypnea with i) a respiratory rate (RR) \> 30 breaths/min and ii) a SpO2 readings \<90% on room air.
•4. Less than or equal to 8 days from COVID-19 symptom onset prior to randomization. Symptoms are defined as one or more of the following: cough, fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches, weakness/fatigue, chills/sweating, headache, confusion, sore throat, runny nose/congestion, loss of taste or smell, or any other COVID-19 symptoms as determined by the Investigator.
•5. Requiring supplemental oxygen by i) mask or tongs, or ii) high-flow oxygen (WHO category 4 and 5).
•6. Currently on the standard of care (SOC) for COVID-19 infection as prescribed by the investigator/ treating physician.
•7. The SOC will include one or more of the following:
•* Anticoagulants
•* Antibiotics
•* Corticosteroid
+17 more criteria

Exclusion Criteria

•1. Hospitalized for more than 48 hours.
•2. FBG levels ≥ 200 mg/dL
•3. Known or suspected allergy to any of the ingredients in the investigational product or standardized meals.
•4. Currently undergoing invasive mechanical ventilation (including venous ECMO) at the time of screening. (WHO category 6 and 7).
•5. ALT/AST \> 2.5 times the upper limit of normal or a history of decompensated cirrhosis.
•6. Serum creatinine \> 2 times the upper limit of normal.
•7. Patients currently on monoclonal antibodies including antibody cocktails.
•8. Patients for whom, in the opinion of the Investigator, progression to death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment.
•9. Patients for whom, in the opinion of the Investigator, progression to mechanical ventilation is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment.
•10. Possibility of the patient being discharged from hospital within 24 hours.
+14 more criteria

Locations (12)

Aman Hospital and Research Center

Vadodara, Gujarat, India

Dept of critical care medicine, new trauma centre, rajendra institute of medical sciences (RIMS),

Ranchi, Jharkhand, India

St. George's Hospital

Mumbai, Maharashtra, India

BAJ RR Hospital

Mumbai, Maharashtra, India

Pulse Multispeciality Hospital

Pune, Maharashtra, India

Jeevanrekha Multispeciality Hospital

Pune, Maharashtra, India

Ojas Multispeciality Hospital

Pune, Maharashtra, India

Krishna institute of medical sciences Deemed To Be University

Satara, Maharashtra, India

Acharya Vinoba Bhave Rural Hospital

Wardha, Maharashtra, India

Kalinga Institute of Medical Sciences (KIMS)

Bhubaneswar, Odisha, India

Key Dates

Start Date

December 27, 2021

Primary Completion Date

July 16, 2022

Completion Date

July 16, 2022

Last Updated

September 23, 2024

Enrollment

ACTUAL participants

Conditions

COVID-19 Infection

Interventions

Nicotinamide Mononucleotide

OTHER

Nicotinamide Mononucleotide with L-Leucine

OTHER

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study to Evaluate the Effect of Nicotinamide Mononucleotide (NMN) As an Adjuvant to Standard of Care (SOC) On Fatigue Associated With COVID-19 Infection

Inclusion Criteria

Exclusion Criteria

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