Ayan Sen, M.D.

Closed for Enrollment

• A Phase II, Open-label, Randomized, Multicenter Study to Investigate the Pharmacodynamics, Pharmacokinetics, Safety and Efficacy of 8 mg/kg OR 4 mg/kg Intravenous Tocilizumab in Patients with Moderate-to-Severe COVID-19 Pneumonia (CA42481) Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The purpose of this study is assess the pharmacodynamics, pharmacokinetics, safety and effectiveness of two different doses of Tocilizumab (TCZ) in combination with Standard of Care (SOC) in hospitalized adult patients with moderate-to-severe COVID-19 pneumonia. 

• A Phase III, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of LJPC-501 in Patients with Catecholamine-Resistant Hypotension (CRH) (ATHOS-3) Scottsdale/Phoenix, Ariz.

  The purpose of this study is to assess the effect, safety, and tolerability of LJPC-501 (angiotensin II) in adult patients diagnosed with catecholamine-resistant hypotension.

• A Randomized Placebo-Controlled Safety And Dose-Finding Study For The Use Of The Il-6 Inhibitor Clazakizumab in Patients With Life-Threatening COVID-19 Infection Scottsdale/Phoenix, Ariz.

  The primary purpose of this study is to assess the safety of clazakizumab treatment in COVID-19 infected patients with respiratory failure due to hyperinflammation related to cytokine storm.

• Ascorbic Ccid, Hydrocortisone, and Thiamine in Sepsis and Septic Shock - A Randomized, Double-Blind, Placebo-Controlled Trial Scottsdale/Phoenix, Ariz.

  The purpose of this study is to determine whether the combination of Ascorbic Acid (Vitamin C), Thiamine (Vitamin B1), and Corticosteroids improves the trajectory of organ failure and reduces mortality in patients with sepsis and septic shock as compared to placebo.

• Continuous Blood Lactate Monitoring in Critically Ill Patients Scottsdale/Phoenix, Ariz.

  The purpose of this study is to use patient blood and blood data to help develop and then validate a device to continuously monitor blood levels of lactate in the critically ill.

• Expanded Access for LJPC-501 Scottsdale/Phoenix, Ariz.

  The primary objective of the study is to provide access to LJPC-501 for distributive shock patients who remain hypotensive despite receiving fluid and vasopressor therapy.

• Wearable Vital Signs Monitoring for Detection of SIRS (Systemic Inflammatory Response Syndrome) and Sepsis in a Hematopoietic Stem Cell Transplant Population Scottsdale/Phoenix, Ariz.

  The purpose of this study is to validate the effectiveness of the ZephyrLife Home monitoring device compared with standard ICU or stepdown vital signs monitoring,  especially for heart rate, respiratory rate and temperature as systemic (whole body) inflammatory response syndrome or sepsis ( whole body infection) markers in stem cell transplant patients.

• Wearable Wireless Vital Signs Monitoring in Predicting Clinical Decompensation Scottsdale/Phoenix, Ariz.

  The purpose of the study is to validate wearable device monitoring with standard ICU/stepdown patient vital signs monitoring especially heart rate, telemetry, respiratory rate, blood pressure, and pulse oximetry.

• Zinc Versus Multivitamin Micronutrient Supplementation to Support Immune Health in the Setting of COVID-19 Pandemic: A randomized study (Zn COVID Study) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The purpose of this study is compare high dose (69.6 mg/day) Zinc to multivitamin supplementation on immune health as used by primary health care staff and individuals over 50 years old identified, by hypothesis generated from observations among the pandemic to date, as being at risk populations to COVID-19. In order to ensure consistent nutritional supplementation, the PreserVision AREDS formulation gel tabs will be recommended for those randomized to Zinc and the Adult (under 50) Centrum formulation recommended for those randomized to multivitamin.