RESUMO
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 deï¬nitive 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.
Assuntos
COVID-19 , Adulto , Humanos , Progressão da Doença , Hospitalização , Tempo de Internação , Estudos Prospectivos , SARS-CoV-2 , Resultado do TratamentoAssuntos
COVID-19/epidemiologia , COVID-19/imunologia , Infecções por HIV/epidemiologia , Infecções por HIV/imunologia , Fatores Ativadores de Macrófagos/imunologia , Proteína de Ligação a Vitamina D/imunologia , COVID-19/terapia , Proteínas de Ligação a DNA/genética , Estrogênios/metabolismo , Infecções por HIV/terapia , Humanos , Sistema Imunitário , Imunoterapia , Itália/epidemiologia , Modelos Teóricos , Neoplasias/imunologia , Pandemias , Polimorfismo Genético , Fatores de Transcrição/genética , Vitamina D/genética , Tratamento Farmacológico da COVID-19RESUMO
During the past decades, a great bulk of studies have been undertaken to investigate the pathophysiologic mechanisms responsible for thrombus formation. As a consequence, different therapeutic strategies interfering at different levels of the coagulation process have been developed. Many of these compounds did not achieve full development, but others are presently available for the clinician. The present review paper will focus on these new therapeutic strategies developed in the last 10 years.