Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation Strategy Trial
Recruiting
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients. This trial is designed to determine whether intensification of immune modulation early in the course of the disease (while patients are on low flow oxygen) with abatacept (active arm) combined with standard of care (SOC) improves recovery as compared with placebo + SOC (placebo arm). For both groups, intensification of immunomodulation will be... Read More
Gender:
All
Ages:
18 years and above
Trial Updated:
12/07/2023
Locations: Vanderbilt University Medical Center (Site 212-001), Nashville, Tennessee
Conditions: COVID-19
Strategies and Treatments for Respiratory Infections &; Viral Emergencies (STRIVE): Shionogi Protease Inhibitor
Recruiting
Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622, an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi &; Co. Ltd. The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of S-217622 when given in addition to standard of... Read More
Gender:
All
Ages:
18 years and above
Trial Updated:
12/07/2023
Locations: Vanderbilt University Medical Center (Site 212-001), Nashville, Tennessee
Conditions: COVID-19
Reparixin as add-on Therapy to Standard of Care to Limit Disease Progression in Adult Patients With COVID-19 and Other Community-Acquired Pneumonia.
Recruiting
Primary objective: - To evaluate the efficacy of oral reparixin versus standard care alone in limiting disease progression in adult patients hospitalised for infectious pneumonia acquired in the community (CAP), including COVID-19. Secondary objectives: - To determine the effect of reparixin on several disease severity/progression measures including recovery, ventilatory free days and mortality. Safety objectives: - To evaluate the safety of oral reparixin versus placebo in the specific cli... Read More
Gender:
All
Ages:
18 years and above
Trial Updated:
11/27/2023
Locations: University of Tennessee Medical Center, Knoxville, Tennessee
Conditions: Infectious Pneumonia, Severe COVID-19
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)
Recruiting
The purpose of this study is to evaluate the effectiveness of repurposed medications (study drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19. Participants will receive either study drug or placebo. Participants will self-report any new or worsening symptoms or medical events experienced while taking study drug or placebo. This study is intended to be all remote with no in person visits, unless the study team feels it is in the best interest of a partic... Read More
Gender:
All
Ages:
30 years and above
Trial Updated:
11/26/2023
Locations: Clinical Trials Center of Middle TN, Franklin, Tennessee +3 locations
Conditions: Covid19
Pilot Randomized Study of RD-X19 Tx Device in Subjects With PCC (Long Covid) in the Outpatient Setting
Recruiting
Duration of Treatment: 7 days, 2 times per day. Following Randomization on Week 1 Day 1, Subjects will continue to have televisits and rate symptoms and upright activity weekly during a 5 week follow up. Subjects will be followed via in clinic visits at week 2/day 8 (+3/-0 days) and Week 6 / day 36, (+3/-3days). Subjects will receive a weekly televisit during Week 3 / day 15 (+3/-3), Week 4 / day 22 (+3/-3), and Week 5 / day 29 (+3/-3).
Gender:
All
Ages:
22 years and above
Trial Updated:
11/16/2023
Locations: Site 1_Helios - Physician Quality Care, Milan, Tennessee
Conditions: Post COVID-19 Condition (PCC)
EPIC-Peds: A Study to Learn About the Study Medicine Called PF-07321332 (Nirmatrelvir)/Ritonavir in Patients Under 18 Years of Age With COVID-19 That Are Not Hospitalized But Are at Risk for Severe Disease
Recruiting
The purpose of this clinical trial is to learn about the safety, pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it), and efficacy (how well a study treatment works in the study) of the study medicine (called nirmatrelvir/ritonavir) for potential treatment of coronavirus disease 2019 (COVID-19). The study medicine will be given to patients under 18 years of age with COVID-19 that are not hospitalized but are at risk for... Read More
Gender:
All
Ages:
Between 0 years and 17 years
Trial Updated:
10/31/2023
Locations: Le Bonheur Children's Hospital, Memphis, Tennessee +1 locations
Conditions: COVID-19
Evaluation of Immunologic Response Following COVID-19 Vaccination in Children, Adolescents, and Young Adults With Cancer
Recruiting
This study evaluates immunologic response following COVID-19 vaccination in children, adolescents, and young adults with cancer. Vaccines work by stimulating the body's immune cells to respond against a specific disease. The immune response produces protection from that disease. Effects from cancer and from treatments for cancer can reduce the body's natural disease fighting ability (called immunity). Factors such as vaccine type, timing of vaccine dosing related to treatment for cancer and numb... Read More
Gender:
All
Ages:
Between 6 months and 37 years
Trial Updated:
10/26/2023
Locations: East Tennessee Childrens Hospital, Knoxville, Tennessee +2 locations
Conditions: COVID-19 Infection, Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children
Recruiting
The purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called variant-adapted BNT162b2 RNA-based vaccine) in healthy children. The trial is divided into 5 individual studies or substudies based on age group and prior history of COVID-19 vaccinations. All participants in each of the 5 sub-studies will receive study vaccine as a shot depending on what group they are in. Substudy A design: Phase 1 includes participant... Read More
Gender:
All
Ages:
Between 6 months and 11 years
Trial Updated:
10/18/2023
Locations: St. Jude Children's Research Hospital, Memphis, Tennessee +1 locations
Conditions: SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19
Evaluation of the RD-X19 Treatment Device in Individuals With Mild COVID-19
Recruiting
This is a randomized, double-blind, sham controlled, stratified, pivotal efficacy and safety study of the EmitBio RD-X19 treatment device in Individuals 40 Years of age and older with Mild COVID-19 in the at-home setting.
Gender:
All
Ages:
40 years and above
Trial Updated:
10/10/2023
Locations: 308 - Kur Research @Complete Health Partners, Nashville, Tennessee
Conditions: COVID-19
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Recruiting
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.
Gender:
All
Ages:
Between 0 years and 20 years
Trial Updated:
09/21/2023
Locations: Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, Tennessee
Conditions: Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Hypertension, Pain, Hyperphosphatemia, Primary Hyperaldosteronism, Edema, Hypokalemia, Heart Failure, Menorrhagia, Insomnia, Pneumonia, Skin Infection, Arrythmia, Asthma in Children, Bronchopulmonary Dysplasia, Adrenal Insufficiency, Fibrinolysis; Hemorrhage, Hemophilia, Attention Deficit Hyperactivity Disorder, Multisystem Inflammatory Syndrome in Children (MIS-C), Kawasaki Disease, Coagulation Disorder, Down Syndrome
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
Recruiting
This is a Phase 2/3 open-label study to evaluate the safety and immunogenicity of a booster dose of the XBB.1.5 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine (SARS-CoV-2 rS) adjuvanted with Matrix-M™ in previously mRNA COVID-19 vaccinated adult participants ≥18 years of age and baseline SARS CoV-2 seropositive COVID-19 vaccine naïve participants ≥18 years of age.
Gender:
All
Ages:
Between 18 years and 54 years
Trial Updated:
09/07/2023
Locations: AMR, Knoxville, Tennessee
Conditions: COVID-19
Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study
Recruiting
AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19. The aim of the Phase I/III study (Parent Study) will be to evaluate the safety, efficacy and neutralizing activity of AZD3152 compared with comparator for pre exposure prophylaxis of COVID-19, and separately evaluate the safety and PK of AZD5156, a combination of AZD3152 and AZD1061. Sub-study: This Phase II sub-study of SUPERNOVA... Read More
Gender:
All
Ages:
12 years and above
Trial Updated:
09/05/2023
Locations: Research Site, Knoxville, Tennessee
Conditions: COVID-19, SARS-CoV-2