Safety and Effects of an Investigational COVID-19 Vaccine as a Booster in Healthy People
NCT05541861
Recruiting
This is an exploratory Phase I, randomized, observer-blind, active-controlled, dose escalation trial to evaluate three dose levels (DLs) of BNT162b4 given in combination with BNT162b2 Bivalent to select a safe and tolerable dose. There will be three observer-blind cohorts (1, 2, 3a, and 3b). The trial will use a staggered dosing process schema, i.e., enrollment into the next higher dose level is done sequentially and subject to safety data from the previous dose levels, with sentinel participant... Read More
Gender:
All
Ages:
18 years and above
Locations: Clinical Trials of Texas, LLC / Flourish Research, San Antonio, Texas +16 locations
Conditions: SARS-CoV-2 Infection, COVID-19
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A Study to Learn About COVID-19 Bivalent BNT162b2 Omicron Containing Vaccine in Healthy Children
NCT05543616
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 bivalent BNT162b2 Omicron containing vaccine) in healthy children. The trial is divided into 4 individual studies or substudies based on age group and prior history of COVID-19 vaccinations. All participants in each of the 4 sub-studies study vaccine as a shot depending on what group they are in. Substudy A design: includes participants 6 months through... Read More
Gender:
All
Ages:
Between 6 months and 11 years
Locations: Driscoll Children's Hospital, Corpus Christi, Texas +77 locations
Conditions: SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19
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Study to Evaluate Safety and Immunogenicity of COVID-19 Vaccine in Children 6 Months to < 12 Years
NCT05468736
Recruiting
This is a Phase 2/3 randomized, observer-blinded, placebo-controlled, age de-escalation trial to evaluate the safety and immunogenicity of 2 primary doses and a booster dose of NVX CoV2373 given 21 days apart in pediatric participants (3 age cohorts; 6 to < 12 years, 2 to < 6 years, and 6 to < 24 months of age). Each age cohort will be conducted in 2 parts starting with the oldest age cohort (6 to < 12 years of age).
Gender:
All
Ages:
Between 6 months and 11 years
Locations: Tekton Research, Beaumont, Texas +62 locations
Conditions: COVID-19
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SUNRISE-3: Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19
NCT05629962
Recruiting
The purpose of the study is to evaluate whether bemnifosbuvir (BEM) is effective and safe in adults with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible subjects will be randomly assigned (by chance) to receive BEM or matching placebo orally for 5 days. Co-administration of locally available standard of care (SOC) is allowed. The total duration of the study is 60 days.
Gender:
All
Ages:
18 years and above
Locations: Atea Study Site, Houston, Texas +55 locations
Conditions: SARS CoV 2 Infection, COVID-19
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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
NCT05261139
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
Locations: Texas Children's Hospital, Houston, Texas +100 locations
Conditions: COVID-19
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A Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVID-19
NCT05386472
Recruiting
The purpose of this clinical trial is to learn about how study medicine (Paxlovid, which contains nirmatrelvir and ritonavir) is changed and eliminated from the body, as well as its safety, and the extent to which side effects can be tolerated for treatment of pregnant women with mild or moderate COVID-19 compared to non-pregnant women with mild or moderate COVID-19. This study is seeking participants who: are expecting a healthy baby and are in their second or third trimester pregnancy and ha... Read More
Gender:
Female
Ages:
Between 18 years and 50 years
Locations: St. David's Medical Center, Austin, Texas +25 locations
Conditions: COVID-19
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SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies
NCT05765396
Recruiting
The goal of this observational study is to evaluate new non-invasive passive surveillance technologies, Level 42 AI imPulse™ for the detection of COVID-19 in asymptomatic and symptomatic individuals over age of 18 undergoing COVID-19 screening and testing at BAMC Ft Sam Houston, TX; with and without COVID-19. The hypotheses are: (H1) The imPulse™ Una e-stethoscope has at least a similar discriminative and detection ability among symptomatic and asymptomatic COVID-19 carrier versus those not in... Read More
Gender:
All
Ages:
Between 18 years and 89 years
Locations: Brooke Army Medical Center, Fort Sam Houston, Texas
Conditions: COVID-19, SARS-CoV-2 Virus, COVID-19 Pneumonia, COVID-19 Respiratory Infection, COVID-19 Acute Respiratory Distress Syndrome, Corona Virus Infection
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ACTIV-6: COVID-19 Study of Repurposed Medications - Arm F (Montelukast)
NCT05894577
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. They will self-report any new or worsening symptoms or medical events they may experience 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
Locations: Express Family Clinic, Allen, Texas +108 locations
Conditions: Covid19
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Novel Experimental COVID-19 Therapies Affecting Host Response
NCT04924660
Recruiting
The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19.
Gender:
All
Ages:
18 years and above
Locations: UT Southwestern Medical Center, Dallas, Texas +71 locations
Conditions: COVID-19, SARS-CoV-2 Infection, Coronavirus Infection
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A Study Evaluating Tocilizumab in Pediatric Patients Hospitalized With COVID-19
NCT05164133
Recruiting
This is a single-arm, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and exploratory efficacy of tocilizumab (TCZ) for the treatment of pediatric patients from birth to less than 18 years old hospitalized with COVID-19 and who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
Gender:
All
Ages:
17 years and below
Locations: UT Physicians - Pediatric Center - Texas Medical Center, Houston, Texas +25 locations
Conditions: COVID-19
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Study of Obeldesivir in Nonhospitalized Participants With COVID-19
NCT05715528
Recruiting
The goal of this clinical study is to test if obeldesivir (formerly GS-5245) is safe and effective for the treatment of coronavirus disease 2019 (COVID-19) in participants who have a standard risk of developing severe illness. This study will also measure how much obeldesivir gets into the blood and how long it takes for the body to get rid of it.
Gender:
All
Ages:
Between 12 years and 64 years
Locations: PharmaTex Research, Amarillo, Texas +142 locations
Conditions: COVID-19
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Reparixin as add-on Therapy to Standard of Care to Limit Disease Progression in Adult Patients With COVID-19 and Other Community-Acquired Pneumonia.
NCT05254990
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
Locations: Baptist Hospitals of Southeast Texas, Beaumont, Texas +64 locations
Conditions: Infectious Pneumonia, Severe COVID-19
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