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UC Davis Health Clinical Studies

Testing the Safety and Effectiveness of Experimental Sarilumab in Hospitalized Patients With COVID-19 (Coronavirus)

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You are being asked to take part in a research study because you have the COVID‑19 virus. This study will test the safety and effectiveness of the experimental drug, sarilumab (study drug). This study is sponsored by Regeneron Pharmaceuticals, Inc. (“Regeneron”). Sarilumab (also known as Kevzara®) is considered an experimental drug in this study. It has not been approved by the FDA for the condition being studied. However, it has been approved in multiple countries for active rheumatoid arthritis. Sarilumab is a type of drug called a “monoclonal antibody”. An antibody is a special kind of protein that your immune (defense) system normally makes to fight bacteria and viruses. Scientists can now make antibodies in the laboratory for the treatment of many different diseases. Sarilumab has been specifically shown to block the action of a protein called interleukin-6 (IL-6) in your body. Interleukin-6 (IL-6) is a protein in the immune system that has been shown to play an important role in inflammation. Inflammation may be associated with symptoms and complications of COVID‑19. The main purpose of this study is to determine if sarilumab is safe and if it can decrease the amount of time you have COVID-19 symptoms.

Drug study, Phase 2/3
Any, age 18 years or older

Experimental Treatment with Remdesivir for Patients Hospitalized With Coronavirus Infection (COVID-19)

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There are no approved medications to treat COVID-19 because it is a new disease caused by a virus that was just identified in 2019 in China. Some people who become sick with COVID-19 have serious disease and must be hospitalized. This study will test a drug in adult patients that are hospitalized with COVID-19. The drug has been tested before in humans with other diseases. In this study, we would like to make sure that it is safe for use in humans with COVID-19 and see if it can improve patients’ health when they are sick with COVID-19. We are studying the experimental use of a drug called remdesivir. This drug has been studied in animals and in people. It is given as an infusion, which means that it is given through a plastic tube attached to a needle that is put into a vein in the arm. To find out if remdesivir (the study drug) works, we need to compare it to getting something that does not have the drug in it, something called a placebo. The placebo looks like the study drug but does not have the drug in it. Using a placebo is common in research studies. The placebo is also given as an infusion. Some people in the study will get the placebo.

Other study, Phase 2
Any, age 18 to 99 years old

Experimental Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)

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RELIANCE is a study comparing two drugs. We are trying to learn which one works better, and is better tolerated in people with Chronic Obstructive Pulmonary Disease (COPD). COPD is a lung disease. We want to compare these drugs in a real world setting. Today, doctors use both Roflumilast and Azithromycin to treat COPD. Research shows that people who take Roflumilast or Azithromycin go to the hospital less often for COPD attacks. The Food and Drug Administration (FDA) has approved Roflumilast for treating COPD with chronic bronchitis. The FDA has not approved Azithromycin for treating COPD. However, the FDA has approved Azithromycin for treating infections. Doctors are allowed to use Azithromycin to treat other conditions when they think it will help their patients. No studies have compared the two medicines to each other. We want to see if Azithromycin is as good as Roflumilast for preventing COPD attacks and thereby decrease hospital visits. Doctors don’t know which drug works best for whom. There are different types of COPD patients, such as current smokers and past smokers. We want to know if one of these medicines is better for patients who smoke.

Drug study, Phase 3
Any, age 40 years or older

A Study of Renal Anhydramnios Fetal Therapy (repeated infusions of replacement amniotic fluid into the womb)

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This research is being done to test repeated infusions of replacement amniotic fluid into the womb. We hope this can reliably rescue the lung function of fetuses that do not make urine, and as a result, have no amniotic fluid. This condition occurs when the fetus has a severe birth defect called congenital bilateral renal agenesis (CoBRA). It can also be caused by fetal renal failure (FRF). We hope to discover whether this fetal intervention can make early pregnancy renal anhydramnios, called EPRA, reliably survivable after birth. We are also doing this study to better understand what happens to EPRA fetuses in the womb that do not receive therapy. During EPRA, the fetus does not have well-developed or functional kidneys and does not make urine. Fetal urine makes up what we commonly call amniotic fluid. This fluid surrounds the fetus and performs many vital functions. The most important function of amniotic fluid is to allow development of the lungs. In normal fetal life, the fetus gets oxygen and releases carbon dioxide through the placenta. Because gas exchange occurs in the placenta, the lungs do not need to function in the womb. They do need to go through a complex developmental process to be ready to work after birth. This developmental process involves the formation of tiny sacs called alveoli in the lungs. They allow the baby to absorb oxygen from the air it breathes in and expel carbon dioxide from the air it breathes out once born. A critical part of the formation of these alveoli is the fluid that fills the lungs during fetal life. The fluid made by the fetus’s lungs causes the alveoli to stretch and grow. If there is no amniotic fluid in the womb, the lung fluid easily escapes from the lungs and cannot perform its vital function of making the alveoli grow. Normally, the amniotic fluid creates enough pressure in the womb to keep the lung fluid in the lungs. Since the amniotic fluid and the lung fluid connect when the fetus opens its mouth and windpipe, the pressure of the amniotic fluid pushes on the lung fluid. This pressure on the lung fluid must be present for the alveoli to develop correctly. Even if the baby’s lungs work well enough after birth for the baby to survive, the baby will still have no kidneys and need dialysis. A pediatric surgeon will need to place a dialysis catheter into the baby’s abdomen. This will allow fluid and toxins to be removed from the baby as a replacement for kidney function and urination. This process is commonly known as peritoneal dialysis. The baby may also need special assistance with feeding and breathing. All of this requires advanced neonatal care in a neonatal intensive care unit (NICU). It is likely that surviving babies will need to be in the NICU for several months before being able to go home. There are frequent challenges with peritoneal dialysis. This includes infection and dialysis catheter malfunction. Not all babies survive because of complications that can arise from peritoneal dialysis. Additionally, surviving babies will eventually need a kidney transplant to survive long-term. Current survival for infants with complete renal failure who survive to receive a kidney transplant is about 70-80%. Organs can come from either living or deceased donors. They require the baby to take medicine every day to prevent his or her body from rejecting the donated kidney. These babies also have problems with the urinary system that normally drains urine from the kidneys namely the bladder and the urethra. This will become an issue after kidney transplant because the urine will need a place to drain and be expelled. A urologic surgeon will need to be involved to help manage this. He or she may need to make a new bladder out of intestine or do other reconstructive surgery.

Procedure study
Female, age 18 to 60 years old

A Study of Chemoradiation With or Without Experimental Atezolizumab For Limited Stage Small Cell Lung Cancer

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This study is being done to answer the following question: Can we lower the chance of small cell lung cancer growing or spreading by adding an experimental immunotherapy drug (atezolizumab) to the usual treatment for this type of cancer? We are doing this study to find out if this approach is better or worse than the usual approach for your type of cancer. The usual approach is defined as care most people get for small cell lung cancer. The usual approach for patients with limited-stage small cell lung cancer who are not in a study is treatment with chemotherapy and radiation therapy.

Radiation study, Phase [2,3]
Any, age 18 years or older

A Study of the Experimental Combination of Osimertinib Plus Savolitinib in Non-Small Cell Lung Cancer (NSCLC)

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You are invited to take part in this research study because you have Non-Small Cell Lung Cancer. The reason for the study is to find a more effective treatment for Non-Small Cell Lung Cancer. Whether you take part or not is completely up to you. This study will test the experimental combination of the approved drug osimertinib (TagrissoTM) and the experimental medication savolitinib. We hope to learn if it will work and be safe when given together for the treatment of Non-Small Cell Lung Cancer. Osimertinib is approved by FDA. Savolitinib is not approved by any health authority. The use of osimertinib with savolitinib is experimental in this study.

Drug study, Phase 2
Any, age 18 to 150 years old

Study to Test the Effectiveness and Safety of Experimetnal Baloxavir Marboxil in Hospitalized Patients With Severe Influenza

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The purpose of this research study is to compare the effects of the study drug when added to the normal standard-of-care you get for the flu. Standard of care therapy is the treatment you would normally receive to treat flu. For example: - Tamiflu®, - Relenza® (other name includes Dectova®), or - Rapivab® (other names include Rapicata™, Peramiflu™, and Alpivab™). We are doing this research to see if adding a new study drug along with standard antiviral drug is safe and effective. It will be compared to using standard antiviral drug alone. In this study, you will get standard-of-care therapy plus baloxavir marboxil (the study drug) or placebo. A placebo looks like a drug but has no active ingredient. Baloxavir marboxil is an experimental drug. This means it has not been tested in patients for the treatment of severe flu that requires hospital treatment. Baloxavir marboxil (brand name Xofluza®) has been approved by the health authority in the United States of America for the treatment of flu, as well as Japan. Applications for approval in other countries are either completed, ongoing or planned.

Drug study, Phase 3
Any, age 12 years or older

A Study of Experimental ABBV-011 Alone and Combined With ABBV-181 for Relapsed or Refractory Small Cell Lung Cancer

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SC-011 is an experimental drug. Experimental means the drug being tested has not been approved by the FDA for the treatment of small cell lung cancer. SC-011 is a type of drug called an antibody-drug conjugate (ADC). SC-011 is made up of a monoclonal antibody (a type of human protein) that is linked to a form of chemotherapy. A monoclonal antibody is a type of protein made in the laboratory that can attach to substances in the body, in this instance, cancer cells. The monoclonal antibody specifically binds to a protein called seizure-related homolog 6 (SEZ6). This can be found on the surface of certain cancer cells. After binding, SC-011 enters the cell and the chemotherapy becomes active. ADCs are designed to try and more precisely deliver chemotherapy to cancer cells. This type of targeted therapy may have fewer side effects. It may be more effective than a treatment that is not directed toward a specific cancer target. Not all advanced cancer tumors produce the SEZ6 protein. If your tumor does not produce SEZ6, it is thought that it is less likely that SC-011 will benefit you. To determine if you express the SEZ6 protein, we will request a tissue sample of your tumor. Depending on which part of the study you participate in (such as Dose Escalation or Dose Expansion), the results of the test will be available to you.

Drug study, Phase 1
Any, age 18 years or older

A Study Testing the Long-term Safety and Effectiveness of Experimental VX-445 Combination Therapy in Cystic Fibrosis

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This study is being done to learn more about the effectiveness and safety of an experimental combination of medicines. The combination of VX-445/tezacaftor (TEZ)/ivacaftor (IVA) will be tested in patients with cystic fibrosis. • The triple combination VX-445/TEZ/IVA is an experimental drug. This means the study drug is not approved by the FDA. It is still being tested for safety and effectiveness. • TEZ in combination with IVA (TEZ/IVA) is approved in certain countries for use in some people living with CF who are 12 years or older. • IVA is approved in a number of countries globally, for use in some people living with CF who are as young as 6 months, depending on the country. If you would like to know in which countries or for which people living with CF TEZ/IVA or IVA has been approved, please ask your Study Doctor.

Drug study, Phase 3
Any, age 12 years or older
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