COVID-19 InfectionNCT05175768
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 study testing Nicotinamide Mononucleotide and Nicotinamide Mononucleotide with L-Leucine in people with COVID-19 Infection, run by Vedic Lifesciences Pvt. Ltd. at 12 sites in India.
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 Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- Nicotinamide Mononucleotide and Nicotinamide Mononucleotide with L-Leucine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 12 sitesIndia
- Study dates
- 27 Dec 2021to 16 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 27Show fewer
- 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).
- 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)
- 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.
- Naturally post-menopausal women with amenorrhea for 1 year will be eligible.
- 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.
- Having given written informed consent by a legally acceptable representative to participate in the research trial.
- Patients ready to abstain from Niacin and/or nicotinamide supplements.
Who cannot join
- 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.
Show all 24Show fewer
- 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.
- Diagnosed for hepatitis B, hepatitis C or uncontrolled HIV.
- Presenting, in the opinion of the Investigator, a clinically significant abnormality with regard to the clinical examination and/or clinical chemistry screening parameters.
- History of cancer in the last 5 years, or currently has cancer, as assessed by Investigator.
- 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.
- Frequent consumption of alcohol (> 2 standard servings of alcohol/day on average).
- History of (assessed by PI) or current tobacco use.
- Patients with history of drug abuse (amphetamines, Cannabinoids, Cocaine and Opiates)
- Inability to provide blood and/or urine samples.
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
India12 sites
Kalinga Institute of Medical Sciences (KIMS)
Bhubaneswar, Odisha, 751024
Jaipur National University Institute for Medical Science and Research Centre
Jaipur, Rajasthan, 302017
Christian Medical College and Hospital
Ludhiana, Punjab, 141008
St. George's Hospital
Mumbai, Maharashtra, 400001
BAJ RR Hospital
Mumbai, Maharashtra, 400053
Pulse Multispeciality Hospital
Pune, Maharashtra, 400053
Jeevanrekha Multispeciality Hospital
Pune, Maharashtra, 412101
Ojas Multispeciality Hospital
Pune, Maharashtra, 9503553685
Dept of critical care medicine, new trauma centre, rajendra institute of medical sciences (RIMS),
Ranchi, Jharkhand, 834009.
Krishna institute of medical sciences Deemed To Be University
Satara, Maharashtra, 415539
Aman Hospital and Research Center
Vadodara, Gujarat, 390021
Acharya Vinoba Bhave Rural Hospital
Wardha, Maharashtra, 442004
About this study
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
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
- Being tested
- Nicotinamide Mononucleotide, Nicotinamide Mononucleotide with L-Leucine, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide MononucleotideOther
Two sachets to be taken orally after breakfast and Two sachets after lunch with water.
Nicotinamide Mononucleotide with L-LeucineOther
Two sachets to be taken orally after breakfast and Two sachets after lunch with water.
PlaceboOther
Two sachets to be taken orally after breakfast and Two sachets after lunch with water.
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide Mononucleotide | Active comparator | Two sachets to be taken orally after breakfast and Two sachets after lunch with water. Receives: 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. Receives: Other: Nicotinamide Mononucleotide with L-Leucine |
| Placebo | Placebo comparator | Two sachets to be taken orally after breakfast and Two sachets after lunch with water. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional fatigue Inventory-20
Effect of on COVID-19 associated fatigue as assessed by the Multidimensional fatigue Inventory-20 scale.
Measured: Upto 28 days
Secondary outcomes (7)
total number of days hospitalized
Effect of IP on Duration of hospitalization by assessing the total number of days hospitalized.
Measured: Upto 28 days
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.
Measured: From baseline (day 0) to day of discharge (Upto 28 days)
Modified Borg Dyspnoea Scale
Effect of IP on breathlessness as assessed by the change in Modified Borg Dyspnoea Scale (mBDS) score
Measured: Day 0, Day 4, Day of discharge, (Day 14 , Day 21) Optional, Day 28
time taken to reach SPO2 ≥ 95%
Effect of IP on time taken to reach SPO2 ≥ 95% without supplemental oxygen measured with pulse oximeter
Measured: Upto 28 days
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
Measured: Upto 28 days
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
Measured: Upto 28 days
Viral load
Effect of IP on SARS-CoV-2 viral load evaluated by RT-PCR (Ct Value)
Measured: Day 0, Day 4, Day of discharge (Upto 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start27 Dec 2021
- Primary completion16 Jul 2022
- Study completion16 Jul 2022
Why it stopped: Required criteria of covid patient was not met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LGD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175768
- Sponsor's protocol ID
- SE/210401/NM/COVID
- Status last verified
- Sep 2024
- First submitted
- 28 Dec 2021
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05175768
- Acronym / sponsor ID
- SE/210401/NM/COVID
- Conditions
- COVID-19 Infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Required criteria of covid patient was not met
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- LGD
- Study start
- 27 Dec 2021 (actual)
- Primary completion
- 16 Jul 2022 (actual)
- Study completion
- 16 Jul 2022 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomized, Double-Blind, Placebo-Controlled
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide Mononucleotide | Active comparator | Other: Nicotinamide MononucleotideTwo sachets to be taken orally after breakfast and Two sachets after lunch with water. |
| Nicotinamide Mononucleotide with L-Leucine | Active comparator | Other: Nicotinamide Mononucleotide with L-LeucineTwo sachets to be taken orally after breakfast and Two sachets after lunch with water. |
| Placebo | Placebo comparator | Other: PlaceboTwo sachets to be taken orally after breakfast and Two sachets after lunch with water. |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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).
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotinamide MononucleotideTwo sachets to be taken orally after breakfast and Two sachets after lunch with water. | Other | Nicotinamide Mononucleotide |
| Nicotinamide Mononucleotide with L-LeucineTwo sachets to be taken orally after breakfast and Two sachets after lunch with water. | Other | Nicotinamide Mononucleotide with L-Leucine |
| PlaceboTwo sachets to be taken orally after breakfast and Two sachets after lunch with water. | Other | Placebo |
Primary outcome
Multidimensional fatigue Inventory-20
Time frame: Upto 28 days
Effect of on COVID-19 associated fatigue as assessed by the Multidimensional fatigue Inventory-20 scale.
7 secondary outcomes
total number of days hospitalized
Time frame: Upto 28 days
Proportion of patients demonstrating clinical improvement
Time frame: From baseline (day 0) to day of discharge (Upto 28 days)
Modified Borg Dyspnoea Scale
Time frame: Day 0, Day 4, Day of discharge, (Day 14 , Day 21) Optional, Day 28
time taken to reach SPO2 ≥ 95%
Time frame: Upto 28 days
the rate of recovered patients discharged
Time frame: Upto 28 days
rate of clinical deterioration
Time frame: Upto 28 days
Viral load
Time frame: Day 0, Day 4, Day of discharge (Upto 28 days)
Results and safety
The study was stopped early (reason given: Required criteria of covid patient was not met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for COVID-19 Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotinamide Mononucleotide and Nicotinamide Mononucleotide with L-Leucine in people with COVID-19 Infection, run by Vedic Lifesciences Pvt. Ltd. at 12 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Required criteria of covid patient was not met). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional fatigue Inventory-20 (time frame: Upto 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.