a pilot study to assess safety and efficacy of sir1-365 in patients with severe covid-19

Conditions: Corona Virus Infection

Summary: primary objective: • to evaluate overall safety and tolerability of sir1-365 in patients with severe covid-19 secondary objectives: * to assess the clinical efficacy of sir1-365 in patients with severe covid-19 * to assess the effects of sir1-365 on multiple inflammatory biomarker levels including c-reactive protein (crp), ferritin, lymphocyte and neutrophil counts, cytokines, and chemokines * to assess the effects of sir1-365 on biomarkers indicative of target engagement in patients with severe covid-19 * to assess the effects of sir1-365 on biomarkers indicative of kidney injury in patients with severe covid-19 * to assess the effects of sir1-365 on biomarkers indicative of cardiovascular endothelial cell damage in patients with severe covid-19 * to characterize plasma pharmacokinetics (pk) of sir1-365 in patients with severe covid-19

study duration per participant is approximately 28 days including a 14-day treatment period

Eligibility criteria:
inclusion criteria: * hospitalized patient with clinical diagnosis of sars-cov-2 virus infection per world health organization criteria including positive nucleic acid test of any specimen (e.g., respiratory, blood, or other bodily fluid) within 2 weeks prior to screening. * symptoms suggestive of severe systemic illness with covid-19, which could include any of the following symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath at rest, or respiratory distress. * clinical signs indicative of severe systemic illness with covid-19, which could include any of the following clinical signs: respiratory rate ≥ 30 per minutes, heart rate ≥ 125 per minute, spo2 ≤ 93% on room air, or pao2/fio2 ratio \< 300 mmhg. * men or women ≥18 but ≤80 years of age at the time of signing the informed consent. * patient is able to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations). exclusion criteria: * patient requires endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20 l/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ecmo), or clinical diagnosis of respiratory failure. * patient with shock defined by systolic blood pressure \< 90 mm hg, or diastolic blood pressure \< 60 mm hg or requiring vasopressor. * patient with multi-organ dysfunction or failure defined by an increase in the sequential organ failure assessment score of 2 points or more. * patient is unlikely to survive beyond 2 days at the discretion of investigator. * patient has used chronic systemic corticosteroids within 2 weeks prior to screening. * patient with positive results for human immunodeficiency virus (hiv) or hepatitis b or c test. * patient has known active tuberculosis (tb), history of uncontrolled tb, suspected or known systemic bacterial or fungal infections within 4 weeks prior to screening. * patient has any other condition, which makes the patient unsuitable for study participation