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 | Terminated

• 1 other identifier: SE/210401/NM/COVID
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 12

Brief 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

Conditions

COVID-19 Infection

Outcome Measures

Primary Outcomes (1)

• Multidimensional fatigue Inventory-20

  Effect of on COVID-19 associated fatigue as assessed by the Multidimensional fatigue Inventory-20 scale.

  Upto 28 days

Secondary Outcomes (7)

• total number of days hospitalized

  Upto 28 days

• Proportion of patients demonstrating clinical improvement

  From baseline (day 0) to day of discharge (Upto 28 days)

• Modified Borg Dyspnoea Scale

  Day 0, Day 4, Day of discharge, (Day 14 , Day 21) Optional, Day 28

• time taken to reach SPO2 ≥ 95%

  Upto 28 days

• the rate of recovered patients discharged

  Upto 28 days

Study Arms (3)

Nicotinamide Mononucleotide

ACTIVE COMPARATOR

Two sachets to be taken orally after breakfast and Two sachets after lunch with water.

Other: Nicotinamide Mononucleotide

Nicotinamide Mononucleotide with L-Leucine

ACTIVE COMPARATOR

Two sachets to be taken orally after breakfast and Two sachets after lunch with water.

Other: Nicotinamide Mononucleotide with L-Leucine

Placebo

PLACEBO COMPARATOR

Two sachets to be taken orally after breakfast and Two sachets after lunch with water.

Other: Placebo

Interventions

Nicotinamide Mononucleotide OTHER

Two sachets to be taken orally after breakfast and Two sachets after lunch with water.

Nicotinamide Mononucleotide

Nicotinamide Mononucleotide with L-Leucine OTHER

Two sachets to be taken orally after breakfast and Two sachets after lunch with water.

Nicotinamide Mononucleotide with L-Leucine

Placebo OTHER

Two sachets to be taken orally after breakfast and Two sachets after lunch with water.

Placebo

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals ≥ 40 years of age at time of enrolment.
• laboratory-confirmed diagnosis of SARS-CoV-2 infection as determined by RT-PCR/ Rapid antigen test/ any other test.
• 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.
• 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.
• Requiring supplemental oxygen by i) mask or tongs, or ii) high-flow oxygen (WHO category 4 and 5).
• Currently on the standard of care (SOC) for COVID-19 infection as prescribed by the investigator/ treating physician.
• The SOC will include one or more of the following:
• Anticoagulants
• Antibiotics
• Corticosteroid
• Other treatment modalities (considered ethical by the investigator with the exception of protocol prohibited medications)
• Patients previously diagnosed with hypertension or currently having a Systolic blood pressure ≥ 130mmHg and/or diastolic ≥ 85 mmHg
• Abdominal obesity with a waist circumference \> 88cm in women and \> 102 cm in men.
• Patients diagnosed with one or more conditions linked to metabolic syndrome, which includes:
• Hyperlipidemia (as defined by a valid report of triglyceride level ≥ 150mg/dL or currently on medication for hyperlipidemia).

You may not qualify if:

• Hospitalized for more than 48 hours.
• FBG levels ≥ 200 mg/dL
• Known or suspected allergy to any of the ingredients in the investigational product or standardized meals.
• Currently undergoing invasive mechanical ventilation (including venous ECMO) at the time of screening. (WHO category 6 and 7).
• ALT/AST \> 2.5 times the upper limit of normal or a history of decompensated cirrhosis.
• Serum creatinine \> 2 times the upper limit of normal.
• Patients currently on monoclonal antibodies including antibody cocktails.
• 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.
• 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.
• Possibility of the patient being discharged from hospital within 24 hours.
• Participation in other anti-COVID-19 interventional trials.
• Other known active infections or other clinical conditions (e.g., chronic obstructive pulmonary disease) that contraindicate aerosolized inhalation; coexisting pneumonia is allowed.
• Patients with known instance of angina or myocardial infarction prior to 3 months of screening visit.
• Patients with current or prior psychiatric illness, seizure disorders, autoimmune disorders, pre-existing severe cardiovascular disease and patients with prior transplants.
• Females who are breast-feeding, lactating, pregnant or intending to become pregnant.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead
• LGD: collaborator

Study Sites (12)

Aman Hospital and Research Center

Vadodara, Gujarat, 390021, India

Location

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

Ranchi, Jharkhand, 834009., India

Location

St. George's Hospital

Mumbai, Maharashtra, 400001, India

Location

BAJ RR Hospital

Mumbai, Maharashtra, 400053, India

Location

Pulse Multispeciality Hospital

Pune, Maharashtra, 400053, India

Location

Jeevanrekha Multispeciality Hospital

Pune, Maharashtra, 412101, India

Location

Ojas Multispeciality Hospital

Pune, Maharashtra, 9503553685, India

Location

Krishna institute of medical sciences Deemed To Be University

Satara, Maharashtra, 415539, India

Location

Acharya Vinoba Bhave Rural Hospital

Wardha, Maharashtra, 442004, India

Location

Kalinga Institute of Medical Sciences (KIMS)

Bhubaneswar, Odisha, 751024, India

Location

Christian Medical College and Hospital

Ludhiana, Punjab, 141008, India

Location

Jaipur National University Institute for Medical Science and Research Centre

Jaipur, Rajasthan, 302017, India

Location

MeSH Terms

Conditions

COVID-19

Interventions

Nicotinamide Mononucleotide; Leucine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ribonucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Sequentially numbered, sealed, opaque envelopes
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 4, 2022
• Study Start: December 27, 2021
• Primary Completion: July 16, 2022
• Study Completion: July 16, 2022
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (12)