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A Master Protocol Assessing the Safety, Tolerability and Efficacy of Anti-Spike (S) SARS-COV-2 Monoclonal
Antibodies for the Treatment of Hospitalized Patients with COVID-19
Rochester, Minn.
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of REGN10933+REGN10987 in hospitalized adult patients with COVID-19.
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A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients
Rochester, Minn.
The purpose of this study is to compare the efficacy and safety of maribavir to valganciclovir for the treatment of cytomegalovirus (CMV) infection in asymptomatic hematopoietic stem cell transplant recipients.
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A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir
Rochester, Minn.
The purpose of this study is to determine if an investigational treatment (Maribavir) is safe and effective in treating transplant recipient patients with cytomegalovirus (CMV) infections that are refractory or resistant to treatment.
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A Randomized, Double-Blind, Multicenter, Phase 3 Study of the Efficacy, Safety, and Tolerability of Brincidofovir versus Valganciclovir for the Prevention of Cytomegalovirus (CMV) Disease in CMV-Seropositive Kidney Transplant Recipients who Received Antilymphocyte Induction Therapy (BCV CMV vGCV)
Rochester, Minn.
The purpose of this study is to compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of CMV disease in kidney transplant recipients who are CMV seropositive pretransplant and received antilymphocyte induction therapy.
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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia (COVACTA)
Rochester, Minn.
The purpose of this study is to evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.
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An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID-19
Rochester, Minn.
Phase 2: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe COVID-19.
Phase 3: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe or critical COVID-19.
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Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients: A Multi-Center Study (QFT-CMV)
Rochester, Minn.
The study will prospectively determine the clinical utility of CMV cell-mediated immunity using the Quantiferon test. The investigators will use the assay results to tailor the duration of CMV prophylaxis in solid organ transplant patients.
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Cepheid Xpert CMV Assay on the GeneXpert Instrument Systems
Rochester, Minn.
The purpose of this study is to evaluate the safety and effectiveness of the VERIS CMV Assay as an aid in the management of anti-CMV treatment for solid organ transplant patients by showing that virus levels are in agreement with the observed clinical status.
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Clinical Performance of the Aptima® CMV Quant Assay on the Panther® System
Rochester, Minn.
The purpose of this study is to evaluate the clinical performance of the Aptima CMV Quant assay on the Panther system in ethylenediaminetetraacetic acid (EDTA) plasma samples from solid organ transplantation recipients (SOTR) and hematopoietic stem cell transplant recipients (HSCTR).
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Evaluation of the Quantiferon CMV Assay To Evaluate the Risk of CMV Relapse After Treatment of CMV Disease in Solid Organ Transplant Recipients
Rochester, Minn.
The overall aim of this study is to determine whether solid organ transplant recipients who develop immunity to cytomegalovirus (CMV) after an initial episode of CMV disease as measured by the QuantiFERON-CMV assay are at lower risk of CMV recurrence in the future.
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Immunogenicity of Nonavalent HPV Vaccine Administered Prior to Living Donor Renal Transplantation in Adult Women: A Prospective, Single-Arm, Multi-Center Clinical Trial
Rochester, Minn.
This trial studies whether the nonavalent human papillomavirus vaccine given to adult women prior to kidney transplantation can help the body build and maintain an effective immune response during the post-transplant period when they receive immunosuppressive drugs to prevent transplant rejection. This study will help inform our scientific understanding about vaccine-induced immune responses among immunosuppressed individuals.
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Prophylaxis Versus Preemptive Therapy for the Prevention of CMV in High-Risk R-D Liver Transplant Recipients (CAPSIL)
Rochester, Minn.
This is a study of two different approaches for the prevention of CMV disease in liver transplant recipients. The primary purpose is to determine if Preemptive therapy is the same or better than Prophylaxis therapy for the prevention of CMV disease in CMV seronegative recipients that receive a CMV positive liver transplant. Patients meeting study criteria and who have provided informed consent will be randomized within 10 days of transplant to receive in an open label design, either antiviral prophylaxis with valganciclovir 900 mg orally once daily for 100 days or preemptive therapy (weekly monitoring for asymptomatic CMV viremia by plasma PCR) for 100 days with initiation of oral valganciclovir 900mg orally twice daily only at onset of CMV viremia and continued until plasma PCR is negative on two consecutive weekly PCR tests.
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SUSTAIN: A Randomized, Double-Blind, Multicenter, Phase 3 Study of the Efficacy, Safety, and Tolerability of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease in CMV Seronegative Kidney Allograft Recipient (SUSTAIN)
Rochester, Minn.
To compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of cytomegalovirus (CMV) disease in kidney transplant allograft recipients who are CMV seronegative pretransplant and received a kidney from a CMV seropositive donor.
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UTILIZATION OF QUANTIFERON CMV ASSAY TO DETERMINE DURATION OF CMV PROPHYLAXIS IN CMV DONOR (+) / RECIPIENT (-) SOLID ORGAN TRANSPLANT RECIPIENTS
Rochester, Minn.
The overall aim of this study is to evaluate the clinical utility of the QuantiFERON-CMV test in solid organ transplant recipients on CMV prophylaxis to predict development of CMV disease after completion of prophylaxis. Our hypothesis is that in CMV D+/R- solid organ transplant recipients, the development of immunity as measured by a positive QuantiFERON CMV assay will predict a lower risk of CMV disease after prophylaxis is completed.
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