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Mental Intervention and Nicotinamide Riboside Supplementation in Long Covid

Plain-language guide to NCT05703074: phase 2 randomized trial of NAD+, 310 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05703074
Phase
phase 2
Status
completed
Start
2023-01-30
Completion (planned or actual)
2024-09-23
Participants
310 (actual)
Design
randomized, quadruple-blind, treatment
Conditions studied
Long COVID
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around NAD+.

Long COVID, also referred to as post-acute sequela of COVID-19 (PASC), is present in a substantial number of individuals, and treatment for this is warranted.

It had four arms (groups): MBRT and NR (other), MBRT and placebo (other), Care as usual and NR (other) and Care as usual and placebo (other).

Psychological therapy and dietary supplement.

Psychological therapy and placebo dietary supplement.

No psychological therapy (information only) and dietary supplement.

The registry classes the interventions as behavioral and dietary supplement.

Who Took Part

Enrollment: 310 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Undergone acute COVID-19, confirmed EITHER by a positive PCR-test OR a positive self-test combined with confirmatory antibody-pattern in blood. Persistent symptoms at least 6 months following acute COVID-19 without symptom-free interval. Functional disability to an extent that impacts negatively on normal activities (such as work attendance, physical exercise, social activities, etc.).

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: other chronic illnesses, demanding life situations or concomitant drug use/substance abuse that is considered a plausible cause of persistent symptoms and associated disability; sustained organ damage (lung, heart, brain) following acute, serious covid-19; insufficient command of norwegian.

How the Study Was Run

It was run as a randomized, factorial and quadruple-blind study.

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

Blinding on both sides kept the participants and researchers unaware of who received NAD+.

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

It started in 2023-01-30 with completion listed for 2024-09-23.

It ran at 1 site in Norway.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Health-related quality of life (time frame: Three months after inclusion (T2)).

It also tracked 6 secondary outcomes, for example Inflammation, Executive functioning, Fatigue, Dyspnoea and Global impression of change.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of NAD+ in 310 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

NAD+: The coenzyme that accepts electrons at complex I.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.