Adjunctive use of oral MAF is associated with no disease progression or mortality in hospitalized patients with COVID-19 pneumonia: The single-arm COral-MAF1 prospective trial.

Autor: Spadera L; Department of Otolaryngology-Head and Neck Surgery, Ospedale del Mare hospital, ASL Napoli 1 Centro, Naples, Italy. Electronic address: lucrezia.spadera@libero.it., Lugarà M; Department of General Medicine, Ospedale del Mare hospital, ASL Napoli 1 Centro, Naples, Italy., Spadera M; Department of Anesthesiology and Intensive Care, San Giovanni Bosco hospital, ASL Napoli 1 Centro, Naples, Italy., Conticelli M; Department of Clinical Pathology, Ospedale del Mare Hospital, ASL Napoli 1 Centro, Naples, Italy., Oliva G; Department of General Medicine, Ospedale del Mare hospital, ASL Napoli 1 Centro, Naples, Italy., Bassi V; Department of General Medicine, San Giovanni Bosco Hospital, ASL Napoli 1 Centro, Naples, Italy., Apuzzi V; Department of General Medicine, San Giovanni Bosco Hospital, ASL Napoli 1 Centro, Naples, Italy., Calderaro F; Department of General Medicine, San Giovanni Bosco Hospital, ASL Napoli 1 Centro, Naples, Italy., Fattoruso O; Department of Clinical Pathology, San Giovanni Bosco Hospital, ASL Napoli 1 Centro, Naples, Italy., Guzzi P; Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Campus Universitario, Germaneto, 88100 Catanzaro, Italy., D'Amora M; Department of Laboratory Medicine and Clinical Pathology, San Paolo Hospital, ASL Napoli 1 Centro, Naples, Italy., Catapano O; Department of Laboratory Medicine and Clinical Pathology, San Paolo Hospital, ASL Napoli 1 Centro, Naples, Italy., Marra R; Department of Pharmacy, Ospedale del Mare Hospital, ASL Napoli 1 Centro, Naples, Italy., Galdo M; Department of Pharmacy, AORN Ospedali dei Colli Monaldi - Cotugno - C.T.O. Hospital, Naples, Italy., Zappalà M; Department of Medicine, Vesuvio Clinic, ASL Napoli 1 Centro, Naples, Italy., Inui T; Department of Life System, Institute of Technology and Science, Graduate School, Tokushima University, Tokushima, Japan; Saisei Mirai Cell Processing Center, Osaka, Japan; Saisei Mirai Keihan Clinic, Osaka, Japan; Saisei Mirai Kobe Clinic, Kobe, Japan., Mette M; Saisei Mirai Keihan Clinic, Osaka, Japan; Saisei Mirai Kobe Clinic, Kobe, Japan., Vitiello G; Department of Health Management, Ospedale del Mare hospital, ASL Napoli 1 Centro, Naples, Italy., Corvino M; Department of Health Management, ASL Napoli 1 Centro, Naples, Italy., Tortoriello G; Department of Otolaryngology-Head and Neck Surgery, AORN Ospedali dei Colli Monaldi - Cotugno - C.T.O. Hospital, Naples, Italy.
Jazyk: angličtina
Zdroj: Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie [Biomed Pharmacother] 2023 Dec 31; Vol. 169, pp. 115894. Date of Electronic Publication: 2023 Nov 21.
DOI: 10.1016/j.biopha.2023.115894
Abstrakt: Based on a growing body of evidence that a dysregulated innate immune response mediated by monocytes/macrophages plays a key role in the pathogenesis of COVID-19, a clinical trial was conducted to investigate the therapeutic potential and safety of oral macrophage activating factor (MAF) plus standard of care (SoC) in the treatment of hospitalized patients with COVID-19 pneumonia. Ninety-seven hospitalized patients with confirmed COVID-19 pneumonia were treated with oral MAF and a vitamin D3 supplement, in combination with SoC, in a single-arm, open label, multicentre, phase II clinical trial. The primary outcome measure was a reduction in an intensive care unit transfer rate below 13% after MAF administration. At the end of the study, an additional propensity score matching (PSM) analysis was performed to compare the MAF group with a control group treated with SoC alone. Out of 97 patients treated with MAF, none needed care in the ICU and/or intubation with mechanical ventilation or died during hospitalization. Oxygen therapy was discontinued after a median of nine days of MAF treatment. The median length of viral shedding and hospital stay was 14 days and 18 days, respectively. After PSM, statistically significant differences were found in all of the in-hospital outcomes between the two groups. No mild to serious adverse events were recorded during the study. Notwithstanding the limitations of a single-arm study, which prevented definitive conclusions, a 21-day course of MAF treatment plus SoC was found to be safe and promising in the treatment of hospitalized adult patients with COVID-19 pneumonia. Further research will be needed to confirm these preliminary findings.
Competing Interests: Declaration of Competing Interest On the behalf of all the authors in paper, I, Dr Lucrezia Spadera, the Submitting Author hereby declares that All authors have completed the Unified Competing Interest form (available on request from the corresponding author) and declares: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
(Copyright © 2023 The Authors. Published by Elsevier Masson SAS.. All rights reserved.)
Databáze: MEDLINE
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