Oral MIB‐626 (β Nicotinamide Mononucleotide) Safely Raises Blood Nicotinamide Adenine Dinucleotide Levels in Hospitalized Patients With COVID‐19 and Acute Kidney Injury: A Randomized Controlled Trial
et al., FASEB BioAdvances, doi:10.1096/fba.2025-00014, NCT05038488, Jun 2025
RCT 42 hospitalized patients with COVID-19 and acute kidney injury (AKI) showing no clinical benefit with MIB-626 (β-nicotinamide mononucleotide) treatment. The study found that 1.0g of MIB-626 twice daily safely and significantly raised blood NAD+ levels, but this did not result in any significant difference in the primary endpoint (serum creatinine). Furthermore, there were no significant differences in secondary endpoints, including other markers of AKI (cystatin C, NGAL, KIM-1), inflammation (CRP, IL-6, TNFa), or overall clinical disease severity.
Standard of Care (SOC) for COVID-19 in the study country,
the USA, is very poor with very low average efficacy for approved treatments1.
Only expensive, high-profit treatments were approved for early treatment. Low-cost treatments were excluded, reducing the probability of early treatment due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.
|
risk of death, 156.0% higher, RR 2.56, p = 1.00, treatment 1 of 25 (4.0%), control 0 of 14 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), day 42.
|
|
risk of no recovery, 18.2% lower, RR 0.82, p = 0.71, treatment mean 1.1 (±1.72) n=19, control mean 0.9 (±1.33) n=15, relative WHO 8-point scale improvement, day 14.
|
|
risk of no recovery, 50.0% higher, RR 1.50, p = 0.80, treatment mean 0.4 (±2.47) n=14, control mean 0.6 (±1.55) n=14, relative mSOFA improvement, day 14.
|
| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Pencina et al., 18 Jun 2025, Double Blind Randomized Controlled Trial, USA, peer-reviewed, mean age 68.4, 16 authors, trial NCT05038488 (history).
Contact: sbhasin@bwh.harvard.edu.
MIB-626 is an oral formulation of β-nicotinamide mononucleotide (NMN), a small molecule NAD+ precursor that may restore host NAD+ levels depleted during SARS-CoV-2 infection.
Oral MIB ‐626 (β Nicotinamide Mononucleotide) Safely Raises Blood Nicotinamide Adenine Dinucleotide Levels in Hospitalized Patients With COVID ‐19 and Acute Kidney Injury: A Randomized Controlled Trial
FASEB BioAdvances, doi:10.1096/fba.2025-00014
Nicotinamide adenine dinucleotide (NAD + ) plays an important role in the innate immune response and is depleted during SARS-CoV-2 infection due to increased turnover. It is unknown whether treatment with NAD + precursors can safely raise NAD + levels in patients with COVID-19. To determine whether MIB-626 (β-nicotinamide mononucleotide), an NAD + precursor, can safely increase blood NAD + levels and attenuate acute kidney injury (AKI) and inflammation in hospitalized patients with COVID-19, 42 adults, ≥ 18 years, hospitalized with COVID-19 and AKI, were randomized in a 3:2 ratio to MIB-626 1.0-g or placebo tablets twice daily for 14 days. Circulating NAD + and its metabolites, markers of AKI, inflammation, and disease severity, were assessed. MIB-626 treatment significantly but gradually raised blood NAD + levels to a peak between 5 to 14 days (16.0 ± 6.9, 25.5 ± 12.6, and 42.6 ± 25.6 μg/mL at baseline, days 5 and 14) and raised plasma concentrations of NAD + metabolites 1-methylnicotinamide, N-methyl, 2-pyridone, 4-carboxamide rapidly to a peak by day 3. Changes in serum creatinine, cystatin-C, and serum markers of AKI did not differ significantly between groups. Serum CRP, IL-6, and TNFα and indices of disease severity also did not differ between groups. MIB-626 treatment of patients with COVID-19 and AKI safely and substantially raised blood NAD + and plasma concentrations of NAD + metabolites. Markers of AKI, inflammation, and disease severity did not differ between groups, likely due to the slow rise in NAD + levels. Future studies should assess whether a rapid increase in NAD + by parenteral administration can attenuate disease severity and AKI.
Author Contributions S.B., K.M.P., D.J.L., and S.S.W. designed the trial; S.B. obtained the funding for the trial; D.E.L., R.J.V., T.S.M., E.V., D.F., T.J., N.K.L., S.L., S.K., Y.M.-B., and S.K. performed research; K.M.P., T.S.M., T.J., and Y.V.S. analyzed the data; K.M.P. and S.B. wrote the first version of the paper; T.S.M. and T.J. developed the case report forms and the secure database; all other co-authors reviewed the paper and provided critical feedback.
Conflicts of Interest The authors have disclosed their other interests below, but none poses
Supporting Information Additional supporting information can be found online in the Supporting Information section.
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"title": "Oral\n <scp>MIB</scp>\n ‐626 (β Nicotinamide Mononucleotide) Safely Raises Blood Nicotinamide Adenine Dinucleotide Levels in Hospitalized Patients With\n <scp>COVID</scp>\n ‐19 and Acute Kidney Injury: A Randomized Controlled Trial",
"type": "journal-article",
"update-policy": "https://doi.org/10.1002/crossmark_policy",
"volume": "7"
}
Late treatment
is less effective
is less effective
