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Systemic Autoimmune Diseases clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT04690816 Recruiting - Clinical trials for Systemic Autoimmune Diseases

Natural History of Coronavirus Disease (COVID-19) in Systemic Autoimmune Diseases

Start date: February 11, 2021
Phase:
Study type: Observational

Background: Viral infections such as COVID-19 may lead to flare-ups in people with systemic autoimmune diseases (SAD). These infections may also change the function of their immune system and/or cause problems with their blood vessels. Researchers want to learn how people with SAD respond to treatments or vaccines for COVID-19. Objective: To understand how COVID-19 affects inflammation, the immune system, and blood vessels in adults and children with autoimmune diseases. Eligibility: People ages 15 and older who have been diagnosed with an autoimmune disease or are a healthy volunteer Design: Participants will have a screening visit. This will include: Medical history and physical exam EKG Chest x-ray COVID-19 test. A swab will be put in the participant s nose or the back of their mouth. Blood and urine tests Participants will be placed into 1 of 4 groups: 1. Those with previously documented COVID-19 infection or COVID vaccination 2. Those with a recently known COVID-19 exposure or vaccination 3. Those with no known COVID-19 exposure or vaccination 4. Those who developed an acute COVID-19 infection Depending on their group, participants will have 1 to 5 more visits. These will occur over 12 to 18 months. Visits may include: FDG PET/CT scan. Participants will lie in a doughnut-shaped machine. The machine creates pictures of the body. For the scan, they will have a radioactive substance injected into their arm through an IV. Kidney function tests Non-invasive vascular studies test. These tests are similar to what it feels like to have blood pressure checked.