This study is testing an experimental drug called "LY3819253" that will provide antibodies that is thought to fight the COVID-19 virus.The subject will receive the study drug (either the experimental study drug or the placebo) only once, on the day he/she joins the study (study "Day 0"). The subject will get it by an intravenous (IV) drip through a tube attached to a needle in the arm. This is called an infusion. As part of the study the subject will also get a study drug called remdesivir once a day intravenously for up to 10 days while in the hospital, as care for COVID-19, unless the study doctor thinks remdesivir would not be safe to be taken. The study will last for 90 days.
This study is testing MK-5475 in people with pulmonary hypertension (high blood pressure in the blood vessel of the lung) linked to COPD (a chronic lung disease where it is hard to breathe). You may be able to join Part 2 of this study if you have pulmonary hypertension linked to COPD, and you are at least 40 years old but not more than 80 years old. About 24 subjects will be in Part 2 of this research. People from Part 1 of this study may be allowed to enter Part 2.
The main objective of this study is to analyze sputum collected from the residue remaining from bronchoalveolar lavage (BAL) procedures to compare the cellular characteristics of BAL samples to those of sputum samples collected from the acapella® airway assist device. We intend to enroll volunteers who are being evaluated by an MUSC pulmonologist as part of their standard medical care. The Control Sputum sample will be collected by volunteers at home over a three day period using an acapella® airway assist device. The cellular profiles of the BAL and sputum samples will be analyzed by flow cytometry. Active participation in this study is expected to last less than one month and will be complete once a sample is obtained from the BAL procedure.
BLUE CORAL is an observational, biorepository study for patients who are hospitalized with COVID-19. The study collects various data and biospecimens, such as blood, urine, and tracheal aspirates, during the patient's hospital stay. The data and biospecimens collected will be used to provide greater knowledge on the biology and epidemiology of COVID-19.
This study is investigating a way to deliver the same medication (treprostinil) that you know as Tyvaso with a much smaller device. This involves combining a dry powdered form of treprostinil with a small, portable dry powder inhaler. In this form, Treprostinil Inhalation Powder will be referred to as "study drug" or "TreT". The TreT powder will be released from the inhaler when you breathe in. The purpose of this research study is to investigate the safety and how well TreT is tolerated in participants with PAH currently treated with Tyvaso. In addition, the levels of Tyvaso and the TreT in your blood will be determined. About 45 subjects will participate in this study from about 20 medical centers. Your participation in this study is voluntary and will last approximately 7 weeks (this may include a 2-week screening period plus the 5-week study period).
Alpha-1 Antitrypsin (AAT) is a naturally occurring protein involved in the protection of lungs from inflammation. A mutation in the AAT gene (a change in the body's genetic instructions on how to make AAT) causes it to be made incorrectly and very little of it gets into the bloodstream. Severe AAT deficiency (lack of AAT in the blood) causes emphysema, which causes holes in the lungs. This study is being done to learn more about the safety and effectiveness of VX-864 in patients with Alpha-1 Antitrypsin Deficiency.
The treatment period is 28 days with 3 additional follow-up visits. Participants will be randomized to one of 4 groups. Randomized means there is an equal chance of being placed in any of the 4 groups. The groups are placebo (no active drug) or treatment groups 1-3 with varying doses. All groups will take 5 tablets in the morning and 5 tablets at night. The treatment group will take either 100mg, 300mg, or 500mg tablets twice a day. There is an 80% chance of being assigned to a treatment group and a 20% chance of being assigned to placebo.
The SIMPLIFY study is being done to test whether or not it is safe to stop taking inhaled hypertonic saline or Pulmozyme® (dornase alfa) in those people that are also taking Trikafta™. The SIMPLIFY studyl consists of two similar studies conducted within the same protocol that are being done to answer the following questions:
• Study A: For people with CF taking Trikafta, does stopping treatment with hypertonic saline (at least 3%) have a similar effect on lung function as continuing treatment with hypertonic saline?
• Study B: For people with CF taking Trikafta, does stopping treatment with Pulmozyme have a similar effect on lung function as continuing treatment with Pulmozyme?
There are a total of 4 study visits (a screening visit and three additional visits during the active part of the study). There is a 2-week screening period and a 6-week active study period.About 920 people with CF who are 12 years of age or older will take part in this study at approximately 80 hospitals and clinics around the country. Of this total, approximately 520 people will participate in the hypertonic saline (Study A) portion and 400 people with participate in the Pulmozyme (Study B) portion of the study.
This clinical study is testing the safety (if there are side effects) and tolerability of CB-280 in approximately 32 subjects with CF. This study is being conducted to indentify which CB-280 doses are safe to take without causing too many side effects. CB-280 is an investigational drug that is taken by mouth that blocks an enzyme called arginase, which is thought to play an important role in promoting lung infection in cystic fibrosis (CF). Participation in the study will be up to 56 days long.
Physicians currently have difficulty getting a biopsy of lung spots that are far from the center of the lung. The bronchoscopes that are currently used to reach these spots are sometimes difficult to maneuver and are unable to reach these spots. This study will test the performance of a new robotic bronchoscope that uses navigation software to find the distant spots in the lung so physicians can successfully get a biopsy.
The purpose of this study is to compare the effects, good or bad, of study treatment with remdesivir plus tocilizumab compared with remdesivir by itself on subjects with severe COVID19 pneumonia. In this study, the subject will receive standard supportive care treatment for COVID-19 pneumonia as well as remdesivir, and will additionally receive either tocilizumab, or placebo. About 450 people will take part in this study. Depending on the early results of the study, the total number of people who will take part may be increased to up to 800.