Virology · 2025
Impact of baseline humoral immunity on treatment outcomes with molnupiravir in the MOVe-OUT randomized, controlled trial.
Клиническое исследование II фазыКлиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Johnson Matthew G, Strizki Julie M, Hilbert David W, Zhang Ying, Carmelitano Patricia, Brown Michelle L, Wolf Dominik J, Paschke Amanda, De Anda Carisa S
Аннотация
BACKGROUND: In the large, randomized, placebo-controlled MOVe-OUT trial, molnupiravir reduced hospitalization/death in unvaccinated, high-risk adults with mild-to-moderate COVID-19. We investigated humoral immune responses and the impact of anti-SARS-CoV-2 antibodies in MOVe-OUT.
METHODS: All participants prospectively underwent serum testing for total antibodies (combined IgA, IgG, and/or IgM) to the SARS-CoV-2 nucleocapsid protein and neutralizing antibodies to the spike protein. For participants with a positive baseline anti-nucleocapsid test, samples were retrospectively tested for subtype-specific IgM and IgG anti-nucleocapsid antibodies. Residual baseline samples from all participants were also retrospectively tested for anti-spike IgG antibodies. Clinical and virologic outcomes according to baseline antibody status were determined.
RESULTS: Fewer participants in the molnupiravir (239/709, 33.7 %) than the placebo arm (259/699, 37.1 %) were positive for any baseline anti-SARS-CoV-2 antibody; anti-spike antibodies only, the specific pattern potentially indicating prior vaccination, were detected in 13.8 % molnupiravir-treated and 15.2 % placebo participants. Molnupiravir reduced the risk of hospitalization/death through day 29 in participants who were seronegative at baseline (molnupiravir 40/470 [8.5 %], placebo 64/440 [14.5 %], 95 % confidence interval for the risk difference: -10.3 % to -1.9 %). Post-baseline, most participants exhibited anti-SARS-CoV-2 antibodies by day 10; by day 29, anti-nucleocapsid antibodies were detected in 93.2 % of molnupiravir-treated and 94.9 % of placebo participants and neutralizing anti-SARS-CoV-2 antibodies in 80.8 % and 82.8 %, respectively.
CONCLUSION: Anti-SARS-CoV-2 antibodies at baseline, more common with placebo, provided protection against poor clinical outcomes. Potentially undisclosed vaccination unlikely impacted the overall trial outcomes. Molnupiravir treatment did not significantly affect development of humoral immunity to SARS-CoV-2 infection.
CLINICALTRIALS: gov: NCT04575597.
METHODS: All participants prospectively underwent serum testing for total antibodies (combined IgA, IgG, and/or IgM) to the SARS-CoV-2 nucleocapsid protein and neutralizing antibodies to the spike protein. For participants with a positive baseline anti-nucleocapsid test, samples were retrospectively tested for subtype-specific IgM and IgG anti-nucleocapsid antibodies. Residual baseline samples from all participants were also retrospectively tested for anti-spike IgG antibodies. Clinical and virologic outcomes according to baseline antibody status were determined.
RESULTS: Fewer participants in the molnupiravir (239/709, 33.7 %) than the placebo arm (259/699, 37.1 %) were positive for any baseline anti-SARS-CoV-2 antibody; anti-spike antibodies only, the specific pattern potentially indicating prior vaccination, were detected in 13.8 % molnupiravir-treated and 15.2 % placebo participants. Molnupiravir reduced the risk of hospitalization/death through day 29 in participants who were seronegative at baseline (molnupiravir 40/470 [8.5 %], placebo 64/440 [14.5 %], 95 % confidence interval for the risk difference: -10.3 % to -1.9 %). Post-baseline, most participants exhibited anti-SARS-CoV-2 antibodies by day 10; by day 29, anti-nucleocapsid antibodies were detected in 93.2 % of molnupiravir-treated and 94.9 % of placebo participants and neutralizing anti-SARS-CoV-2 antibodies in 80.8 % and 82.8 %, respectively.
CONCLUSION: Anti-SARS-CoV-2 antibodies at baseline, more common with placebo, provided protection against poor clinical outcomes. Potentially undisclosed vaccination unlikely impacted the overall trial outcomes. Molnupiravir treatment did not significantly affect development of humoral immunity to SARS-CoV-2 infection.
CLINICALTRIALS: gov: NCT04575597.