Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Nicotinamide Mononucleotide: Two sachets to be taken orally after breakfast and Two sachets after lunch with water for 28 days
Intervention2: Nicotinamide Mononucleotide with L-Leucine:
Sponsors
Dr Shalini Srivastava
Eligibility
Inclusion criteria
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 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 8. Other treatment modalities (considered ethical by the investigator with the exception of protocol prohibited medications) 9. Patients previously diagnosed with hypertension or currently having a Systolic blood pressure � 130mmHg and/or diastolic � 85 mmHg 10. Abdominal obesity with a waist circumference > 88cm in women and > 102 cm in men. 11. 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 - Hyperglycemia (as defined by a valid report of Fasting glucose level � 110 mg/dL or currently on anti-diabetic drugs) 12. Patients with an mBDS score � 3. 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
Exclusion criteria: 1. Hospitalized for more than 48 hours. 2. FBG levels ââ?°Â¥ 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 ââ?¬â?? 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 participantââ?¬•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 participantââ?¬•s ability to successfully and safely complete the study or that may confound study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Effect of on COVID-19 associated fatigue as assessed by the Multidimensional fatigue Inventory-20 (MFI-20) scaleTimepoint: Anytime during duration of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of IP on immune status as assessed by the change in the Anti-SARS-CoV-2 nucleocapsid antibody levels Timepoint: Day 28;Effect of IP on anxiety as assessed by the Generalized Anxiety Disorder Questionnaire (GAD-7) Timepoint: Day 0, Day of discharge, Day 14, Day 21, Day 28;Effect of IP on breathlessness as assessed by the change in Modified Borg Dyspnoea Scale (mBDS) score Timepoint: Day 0, Day 4, Day of discharge, (Day 14 , Day 21) Optional, Day 28;Effect of IP on Duration of hospitalization by assessing the total number of days hospitalized Timepoint: Anytime during duration of study;Effect of IP on hospital discharge rate as assessed by the rate of recovered patients discharged from the hospital Timepoint: Anytime during the study;Effect of IP on immune status as assessed by the change in the Anti-SARS-CoV-2 nucleocapsid antibody levels Timepoint: Day 28;Effect of IP on inflammatory status by assessing the change in serum cytokines (C-reactive protein [CRP] and Interleukin-6 [IL-6]) levels Timepoint: Day 0, Day 4, and Day 7/ day of discharge;Effect of IP on lipid profile as assessed by the change in levels of Total cholesterol (TC), high-density lipoproteins (HDL), low-density lipoprotein (LDL), and triglycerides (TC) Timepoint: Day 0 and Day 28;Effect of IP on quality of life as assessed by the EQ-5D-5L questionnaire. Timepoint: Day 0, Day of discharge, Day 14, Day 21, Day 28;Effect of IP on rate of clinical deterioration as assessed by the proportion of patients fulfilling WHO categories 6, 7 or 8. Timepoint: Throughout hospitalization;Effect of IP on rate of recovery as assessed by the proportion of patients demonstrating clinical improvement defined by the WHO categories 0, 1, 2, or 3 Timepoint: From baseline to day of discharge;Effect of IP on SARS-CoV-2 viral load evaluated by RT-PCR (Ct Value) Timepoint: Day 0, Day 4, Day of discharge;Effect of IP on time taken to reach SPO2 ââ?°Â¥ 95% without supplemental oxygen measured wi | — |
Countries
India
Contacts
Public ContactDr Sonal Raote
Vedic Lifesciences Pvt Ltd
Outcome results
None listed