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

What Was Tested

This registered not phased trial tested NAD+.

It had three arms (groups): Nicotinamide Mononucleotide (active comparator), Nicotinamide Mononucleotide with L-Leucine (active comparator) and Placebo (placebo comparator).

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

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

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

The registry classes the interventions as other.

Who Took Part

69 actual participants took part.

It was open to people of any sex aged from 40 years up to 99 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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. 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:.

The full record lists 27 inclusion and 24 exclusion criteria; among the exclusions: hospitalized for more than 48 hours; 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).

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

The participants were allocated by chance, so the NAD+ group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on NAD+, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2021-12-27 with completion listed for 2022-07-16.

It ran at 12 sites in India (12).

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Multidimensional fatigue Inventory-20 (time frame: Upto 28 days).

It also tracked 7 secondary outcomes, for example total number of days hospitalized, Modified Borg Dyspnoea Scale, the rate of recovered patients discharged, rate of clinical deterioration and Viral load.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of NAD+ in 69 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, all human trials.