BLOG — Covid-19

Abstract Background Targeting mucosal immunity of the gut, which is known to provide antigen processing, while avoiding excessive or unnecessary inflammation, was tested as a way to modulate COVID-19 severity. Methods Randomized open-label trial in 204 adults hospitalized with non-critical COVID-19 who received for 14 days in addition to standard of care (SOC) degalactosylated bovine glycoproteins formulations of either MAF capsules (MAF group) or M capsules (M group) or SOC only (control group). Results Median recovery time when patients did not require supplemental oxygen was 6 days in both study groups compared to 9 days in the control (MAF vs....

Abstract 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 Effect of MAF Capsules and M Capsules on Lymphopenia and Clinical Outcomes in Non-Critical Hospitalized COVID-19 PatientsPreprints with The Lancet 19 Pages Posted: 7 Feb 2023 Abstract BACKGROUND: Excessive inflammation and lymphopenia are linked to poor Covid-19 clinical outcomes. Targeting both conditions using an immunomodulating approach needs to be tested.METHODS: We conducted an open-label, randomized, controlled trial of MAF Capsules and M Capsules in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection but at enrolment did not require resuscitation or mechanical ventilation. Patients were randomly assigned to receive, in addition to standard of care...

In June 2020 we applied to the COVID-19 Scientific Technical Triage of the US FDA for the evaluation of the rationale to study the efficacy of MAF Capsules in COVID-19 treatment.   In June 2020 we applied to the COVID-19 Scientific Technical Triage of the US FDA for the evaluation of the rationale to study the efficacy of MAF Capsules in COVID-19 treatment. The US FDA in PreIND 151946 meeting response recommended a small proof of concept (POC) study as the initial step prior to the large-scale trial be run. The US FDA indicated recommendations including the major study endpoints addressing the...