A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants with Severe COVID-19
The purpose of this study is to provide remdesivir (RDV) to participants with severe COVID-19. The primary objective of this study is to evaluate the efficacy of 2 RDV regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14. The secondary objective of this study is to evaluate the safety and tolerability of RDV.
Principal Investigator:William J. Towner, MD, FACP, FIDSA
Funding Source:Gilead Sciences, Inc.
Funding Years:2020 - 2021
Effectiveness of pneumococcal conjugate vaccine against severe clinical outcomes of coronavirus disease 2019 (COVID-19) among adults: a cohort study
The objectives of this study are to assess the effectiveness of PCV13 against severe COVID-19 outcomes and to assess the burden of PCV13-preventable illness attributable to COVID-19.
Risk of Severe Morbidity and Mortality of Coronavirus Disease 2019 (COVID-19) Among Patients Taking Antihypertensive Medications
The primary objective of this study is to determine the risk of COVID-19 infection and severe morbidity and mortality of COVID-19 among patients with taking ACE inhibitors or ARBs compared with patients taking other classes of medications among patients with hypertension. We will also determine patient and clinical characteristics associated with severe COVID-19.
The Comparative effectiveness of Warfarin and New Oral Anticoagulants for the Extended Treatment of Venous Thromboembolism
The overall goal of this project is to provide information on the benefits and harms comparing different treatment options for the extended treatment of VTE, information that can be used by clinicians and patients in deciding on the optimal treatment strategy.
COVID-19-Related Project Enhancement
Recent studies have reported that COVID-19 is associated with abnormal coagulation profiles and may predispose patients to VTE and other types of thrombotic events. The goals of this study are to determine the risk of VTE following COVID-19 hospitalization and whether the risk of post-hospitalization VTE varies by age, prior history of VTE or severity of COVID-19.
Utilizing Real World Data to Describe Clinical and Safety Outcomes Among Hospitalized COVID-19 Patients, and to Create a Comparator Arm for a Randomized Controlled Trial Evaluating the Efficacy and Safety of Actemra for COVID-19 Patients
Elevated tissue and serum levels of IL-6 have been implicated in the disease pathology of several inflammatory and autoimmune disorders including rheumatoid arthritis, systemic juvenile idiopathic arthritis (sJIA), and cytokine-release syndrome (CRS). Tocilizumab or TCZ (Actemra) is a recombinant humanized, anti-human monoclonal antibody directed against soluble and membrane-bound IL-6R. On March 3rd 2020, TCZ was included in the updated diagnosis and treatment plan for COVID-19 issued by the China National Health Commission as one treatment option for severe or critical forms of COVID-19 pneumonia. However, despite fairly widespread use in China, Actemra has not received health authority approval for COVID-19 in any country. More robust clinical evidence regarding the safety or efficacy of TCZ in the treatment of COVID-19 is needed. Roche is conducting a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of TCZ in combination with SOC compared with matching placebo in combination with SOC in hospitalized adult patients with severe COVID-19 pneumonia (n=330). KPSC is collecting demographic, comorbidity, and clinical information on KPSC patients hospitalized with COVID-19 infection to create a real world data (RWD) comparator arm that will be matched to the TCZ treatment arm of the RCT.