Trial · Interventional
TerminatedNot applicableRegistry dataStudy to Evaluate the Effect of Nicotinamide Mononucleotide (NMN) As an Adjuvant to Standard of Care (SOC) On Fatigue Associated With COVID-19 Infection
This trial was stopped early.
Reason given at the registry: Required criteria of covid patient was not met
Overview
- Status
- Terminated
- Phase
- Not applicable
- Enrollment
- 69 participants (actual)
- Sponsor
- Vedic Lifesciences Pvt. Ltd. · Industry
- Design
- Randomized · Triple masking
- Countries
1 country
India
- Start
- 27 Dec 2021
- Primary completion
- 16 Jul 2022
- Completion
- 16 Jul 2022
- First posted
- 4 Jan 2022
- Last update posted
- 23 Sept 2024
- Conditions
- COVID-19 Infection
Timeline
1 trial · 1 stopped early
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- N/ATerminated
Study to Evaluate the Effect of Nicotinamide Mononucleotide (NMN) As an Adjuvant to Standard of Care (SOC) On Fatigue Associated With COVID-19 Infection
NCT0517576827 Dec 2021 to 16 Jul 2022
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
Interventions
- Nicotinamide MononucleotideOther
- Nicotinamide Mononucleotide with L-LeucineOther
- PlaceboOther
Arms3
Active comparator
Nicotinamide Mononucleotide
Two sachets to be taken orally after breakfast and Two sachets after lunch with water.
Active comparator
Nicotinamide Mononucleotide with L-Leucine
Two sachets to be taken orally after breakfast and Two sachets after lunch with water.
Placebo comparator
Placebo
Two sachets to be taken orally after breakfast and Two sachets after lunch with water.
Primary outcomes1
Outcomes the sponsor listed as primary.
Multidimensional fatigue Inventory-20
Time frame · Upto 28 days
Registry description
Effect of on COVID-19 associated fatigue as assessed by the Multidimensional fatigue Inventory-20 scale.
Secondary outcomes(7)
total number of days hospitalized
Time frame · Upto 28 days
Registry description
Effect of IP on Duration of hospitalization by assessing the total number of days hospitalized.
Proportion of patients demonstrating clinical improvement
Time frame · From baseline (day 0) to day of discharge (Upto 28 days)
Registry description
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.
Modified Borg Dyspnoea Scale
Time frame · Day 0, Day 4, Day of discharge, (Day 14 , Day 21) Optional, Day 28
Registry description
Effect of IP on breathlessness as assessed by the change in Modified Borg Dyspnoea Scale (mBDS) score
time taken to reach SPO2 ≥ 95%
Time frame · Upto 28 days
Registry description
Effect of IP on time taken to reach SPO2 ≥ 95% without supplemental oxygen measured with pulse oximeter
the rate of recovered patients discharged
Time frame · Upto 28 days
Registry description
Effect of IP on hospital discharge rate as assessed by the rate of recovered patients discharged from the hospital
rate of clinical deterioration
Time frame · Upto 28 days
Registry description
Effect of IP on rate of clinical deterioration as assessed by the proportion of patients fulfilling WHO categories 6, 7 or 8
Viral load
Time frame · Day 0, Day 4, Day of discharge (Upto 28 days)
Registry description
Effect of IP on SARS-CoV-2 viral load evaluated by RT-PCR (Ct Value)
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 40 Years up to 99 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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