A hypercytokinemia ending in pulmonary and systemic illness occurs in severe COVID-19 patients. M... more A hypercytokinemia ending in pulmonary and systemic illness occurs in severe COVID-19 patients. Mature T lymphocytes express CD6, a molecule that regulates antigen specific responses of T cells. Itolizumab is an anti-CD6 antibody, which inhibits the proliferation of naïve T-cells and reduces the secrInflammationetion of pro-inflammatory cytokines.
BACKGROUND The Centre of Molecular Immunology of Cuba has developed a programme for the conductio... more BACKGROUND The Centre of Molecular Immunology of Cuba has developed a programme for the conduction of multicenter oncology clinical trials in primary health care centres since 2009. AIM To evaluate the ability to conduct oncology clinical trials in primary health care DESIGN & SETTING: A longitudinal, prospective, analytical study was developed between July 2010 and August 2020 in the Villa Clara province. METHOD Structure, process, and outcome indicators were evaluated by the methods of a structured interview, direct observation, documentary observation and databases analysis. The investigators' curricula vitae, the Investigator Site File, minutes of workshops, the monitoring reports, the clinical trial training records and databases were employed as sources of information. The following criteria were considered: adequate: when the indicator met the standard and not adequate: when the indicator did not meet the standard. RESULTS The six structure indicators reached adequate res...
In COVID-19, the inflammatory cytokine-release syndrome is associated with the progression of the... more In COVID-19, the inflammatory cytokine-release syndrome is associated with the progression of the disease. Itolizumab is a monoclonal antibody that recognizes human CD6 expressed in activated T cells. The antibody has shown to be safe and efficacious in the treatment of moderate to severe psoriasis. Its effect is associated with the reduction of pro-inflammatory cytokines release, including IFN-γ, IL-6 and TNF-α. Here, we report the outcome of three severe and critically ill COVID-19 patients treated with itolizumab as part of an expanded access protocol. Itolizumab was able to reduce IL-6 concentrations in all the patients. Two of the three patients showed respiratory and radiological improvement and were fully recovered. We hypothesize this anti-inflammatory therapy in addition to antiviral and anticoagulant therapy could reduce COVID-19 associated morbidity and mortality.
Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a recent outb... more Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a recent outbreak of coronavirus disease (COVID-19). In Cuba, the first case of COVID-19 was reported on March 11, 2020. Elderly individuals with multiple comorbidities are particularly susceptible to adverse clinical outcomes in the course of SARS-CoV-2 infection. During the outbreak, a local transmission event took place in a nursing home in Villa Clara province, Cuba, in which 19 elderly residents tested positive for SARS-CoV-2. Methods: Based on the increased susceptibility to cytokine release syndrome, inducing respiratory and systemic complications in this population, 19 patients were included in an expanded access clinical trial to receive itolizumab, an anti-CD6 monoclonal antibody. Results: All patients had underlying medical conditions. The product was well tolerated. After the first dose, the course of the disease was favorable, and 18 of the 19 patients (94.7%) were discharged clinically ...
A hypercytokinemia ending in pulmonary and systemic illness occurs in severe COVID-19 patients. M... more A hypercytokinemia ending in pulmonary and systemic illness occurs in severe COVID-19 patients. Mature T lymphocytes express CD6, a molecule that regulates antigen specific responses of T cells. Itolizumab is an anti-CD6 antibody, which inhibits the proliferation of naïve T-cells and reduces the secrInflammationetion of pro-inflammatory cytokines.
BACKGROUND The Centre of Molecular Immunology of Cuba has developed a programme for the conductio... more BACKGROUND The Centre of Molecular Immunology of Cuba has developed a programme for the conduction of multicenter oncology clinical trials in primary health care centres since 2009. AIM To evaluate the ability to conduct oncology clinical trials in primary health care DESIGN & SETTING: A longitudinal, prospective, analytical study was developed between July 2010 and August 2020 in the Villa Clara province. METHOD Structure, process, and outcome indicators were evaluated by the methods of a structured interview, direct observation, documentary observation and databases analysis. The investigators' curricula vitae, the Investigator Site File, minutes of workshops, the monitoring reports, the clinical trial training records and databases were employed as sources of information. The following criteria were considered: adequate: when the indicator met the standard and not adequate: when the indicator did not meet the standard. RESULTS The six structure indicators reached adequate res...
In COVID-19, the inflammatory cytokine-release syndrome is associated with the progression of the... more In COVID-19, the inflammatory cytokine-release syndrome is associated with the progression of the disease. Itolizumab is a monoclonal antibody that recognizes human CD6 expressed in activated T cells. The antibody has shown to be safe and efficacious in the treatment of moderate to severe psoriasis. Its effect is associated with the reduction of pro-inflammatory cytokines release, including IFN-γ, IL-6 and TNF-α. Here, we report the outcome of three severe and critically ill COVID-19 patients treated with itolizumab as part of an expanded access protocol. Itolizumab was able to reduce IL-6 concentrations in all the patients. Two of the three patients showed respiratory and radiological improvement and were fully recovered. We hypothesize this anti-inflammatory therapy in addition to antiviral and anticoagulant therapy could reduce COVID-19 associated morbidity and mortality.
Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a recent outb... more Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a recent outbreak of coronavirus disease (COVID-19). In Cuba, the first case of COVID-19 was reported on March 11, 2020. Elderly individuals with multiple comorbidities are particularly susceptible to adverse clinical outcomes in the course of SARS-CoV-2 infection. During the outbreak, a local transmission event took place in a nursing home in Villa Clara province, Cuba, in which 19 elderly residents tested positive for SARS-CoV-2. Methods: Based on the increased susceptibility to cytokine release syndrome, inducing respiratory and systemic complications in this population, 19 patients were included in an expanded access clinical trial to receive itolizumab, an anti-CD6 monoclonal antibody. Results: All patients had underlying medical conditions. The product was well tolerated. After the first dose, the course of the disease was favorable, and 18 of the 19 patients (94.7%) were discharged clinically ...
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