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

COVID-19 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05175768
• Other study ID #: SE/210401/NM/COVID
• Status: Recruiting
• Phase: N/A
• Start date: December 27, 2021
• Est. completion date: December 27, 2022

Study information

• Verified date: February 2022
• Source: Vedic Lifesciences Pvt. Ltd.
• Contact: Dr.Shalini Srivastava, MBBS
• Phone: 02242172300
• Email: shalini.s[@]vediclifesciences.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 375
• Est. completion date: December 27, 2022
• Est. primary completion date: December 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 99 Years

Eligibility

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

• Other treatment modalities (considered ethical by the investigator with the exception of protocol prohibited medications)

8. Patients previously diagnosed with hypertension or currently having a Systolic blood pressure = 130mmHg and/or diastolic = 85 mmHg

9. Abdominal obesity with a waist circumference > 88cm in women and > 102 cm in men.

10. 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).

• A valid report of HDL < 50mg/dL in women & < 40mg/dL in men.

• Hyperglycemia (as defined by a valid report of Fasting glucose level = 110 mg/dL or currently on anti-diabetic drugs)

11. Patients with an mBDS score = 3.

12. Available for, and agrees to attend, all scheduled trial visits and assessments at the research site, and able to complete all assessments and documents contained in the research trial.

13. Naturally post-menopausal women with amenorrhea for 1 year will be eligible.

14. Females of childbearing potential should be either sexually inactive (abstinent) for 60 days prior to the first dose of the study, throughout the study and for 30 days after completion of the study, or be using one of the following acceptable methods of birth control:

• Surgically sterile (bilateral tubal-ligation, hysterectomy, bilateral oophorectomy) for at least 90 days prior to the first dose of the study.

• IUD in place for at least 60 days prior to the first dose of the study, throughout the study and for 30 days after completion of the study.

• Hormonal contraceptives for at least 90 days prior to the first dose of the study, throughout the study, and for 30 days after study completion.

• Changes to the method of birth control while participating in the study will be judged by the PI for acceptability.

15. Having given written informed consent by a legally acceptable representative to participate in the research trial.

16. Patients ready to abstain from Niacin and/or nicotinamide supplements.

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.

11. Participation in other anti-COVID-19 interventional trials.

12. Other known active infections or other clinical conditions (e.g., chronic obstructive pulmonary disease) that contraindicate aerosolized inhalation; coexisting pneumonia is allowed.

13. Patients with known instance of angina or myocardial infarction prior to 3 months of screening visit.

14. Patients with current or prior psychiatric illness, seizure disorders, autoimmune disorders, pre-existing severe cardiovascular disease and patients with prior transplants.

15. Females who are breast-feeding, lactating, pregnant or intending to become pregnant.

16. Diagnosed for hepatitis B, hepatitis C or uncontrolled HIV.

17. Presenting, in the opinion of the Investigator, a clinically significant abnormality with regard to the clinical examination and/or clinical chemistry screening parameters.

18. History of cancer in the last 5 years, or currently has cancer, as assessed by Investigator.

19. Has a history of, or current neurological (neurodegenerative diseases, epilepsy) or psychiatric pathology that may impact the participant's ability to comply with the requirements of the protocol, as assessed by Investigator.

20. Frequent consumption of alcohol (> 2 standard servings of alcohol/day on average).

21. History of (assessed by PI) or current tobacco use.

22. Patients with history of drug abuse (amphetamines, Cannabinoids, Cocaine and Opiates)

23. Inability to provide blood and/or urine samples.

24. Any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• COVID-19 Infection
• Infections

Intervention

Other:
• Nicotinamide Mononucleotide
Two sachets to be taken orally after breakfast and Two sachets after lunch with water.
• Nicotinamide Mononucleotide with L-Leucine
Two sachets to be taken orally after breakfast and Two sachets after lunch with water.
• Placebo
Two sachets to be taken orally after breakfast and Two sachets after lunch with water.

Locations

Country	Name	City	State
India	Kalinga Institute of Medical Sciences (KIMS)	Bhubaneswar	Odisha
India	Jaipur National University Institute for Medical Science and Research Centre	Jaipur	Rajasthan
India	Christian Medical College and Hospital	Ludhiana	Punjab
India	BAJ RR Hospital	Mumbai	Maharashtra
India	St. George's Hospital	Mumbai	Maharashtra
India	Jeevanrekha Multispeciality Hospital	Pune	Maharashtra
India	Ojas Multispeciality Hospital	Pune	Maharashtra
India	Pulse Multispeciality Hospital	Pune	Maharashtra
India	Dept of critical care medicine, new trauma centre, rajendra institute of medical sciences (RIMS),	Ranchi	Jharkhand
India	Krishna institute of medical sciences Deemed To Be University	Satara	Maharashtra
India	Aman Hospital and Research Center	Vadodara	Gujarat
India	Acharya Vinoba Bhave Rural Hospital	Wardha	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Vedic Lifesciences Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multidimensional fatigue Inventory-20	Effect of on COVID-19 associated fatigue as assessed by the Multidimensional fatigue Inventory-20 scale.	Upto 28 days
Secondary	total number of days hospitalized	Effect of IP on Duration of hospitalization by assessing the total number of days hospitalized.	Upto 28 days
Secondary	Proportion of patients demonstrating clinical improvement	Effect of IP on the rate of recovery as assessed by the proportion of patients demonstrating clinical improvement defined by the WHO categories 0, 1, 2, or 3.	From baseline (day 0) to day of discharge (Upto 28 days)
Secondary	Modified Borg Dyspnoea Scale	Effect of IP on breathlessness as assessed by the change in Modified Borg Dyspnoea Scale (mBDS) score	Day 0, Day 4, Day of discharge, (Day 14 , Day 21) Optional, Day 28
Secondary	time taken to reach SPO2 = 95%	Effect of IP on time taken to reach SPO2 = 95% without supplemental oxygen measured with pulse oximeter	Upto 28 days
Secondary	the rate of recovered patients discharged	Effect of IP on hospital discharge rate as assessed by the rate of recovered patients discharged from the hospital	Upto 28 days
Secondary	rate of clinical deterioration	Effect of IP on rate of clinical deterioration as assessed by the proportion of patients fulfilling WHO categories 6, 7 or 8	Upto 28 days
Secondary	Viral load	Effect of IP on SARS-CoV-2 viral load evaluated by RT-PCR (Ct Value)	Day 0, Day 4, Day of discharge (Upto 28 days)