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 severe disease.

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

Summerville, SC

Florida Pulmonary Research Institute, LLC

Medicine Department - Rheumatology Division

McAllen, TX

Veracruz, Mexico

Clinical Research Support Unit | Mexico City, United States

JM Research SC

Pfizer

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 of SARS-CoV-2 rS with Matrix-M™ adjuvant (NVX-CoV2373) given 21 days apart and NVX CoV2373 or a variant-based vaccine given as a booster dose or at crossover 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).

Study to Evaluate Safety and Immunogenicity of COVID-19 Vaccine in Children 6 Months to < 12 Years

Dayton, OH

Greenville, SC

South Euclid, OH

Clinical Research Centre

Little Rock, AR

Forest Avenue, Richmond, VA

Corning Center for Clinical Research

Plano, TX

Houston, TX

Boynton Beach, FL

Miami, FL

Corpus Christi, TX

Layton Research Center

Idaho Falls, ID

Missoula, MT

San Pedro Sula, Honduras

Anaheim, CA

Bellflower, CA

Long Beach, CA

Pharmacy Department

Novavax

The purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people.

Substudy A:

* This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose,

  * in people who are 12 years of age and older,
  * who previously received at least 3 doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being an Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before the study vaccination (Visit 1).
* The study is about 6 months long for each participant.
* Participants will have at least 5 visits to the clinic.
* At each clinic visit a blood sample will be taken.
* At least 1 nasal swab will taken.

Substudy B:

* This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose,

  * in people who are 12 years of age and older,
  * who are COVID-19 vaccine-naïve
  * who have had any positive SARS-CoV-2 test result \>28 days before study vaccine administration.
* The study is about 6 months long for each participant.
* Participants will have at least 5 visits to the clinic.
* At each clinic visit a blood sample will be taken.
* At least 1 nasal swab will taken.

Substudy C:

* This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi JN.1) and BNT162b2 (Omi KP.2) given as a single 30 µg dose to:

  * Cohort 1: people who are 18 years of age and older, who will receive BNT162b2 (Omi JN.1), and,
  * Cohort 2: people who are 12 years of age and older, who will receive BNT162b2 (Omi JN.1), and,
  * Cohort 3: people who are 18 years of age and older who will receive BNT162b2 (Omi KP.2).
  * Participants may have never received a COVID-19 vaccine or, may have previously received COVID-19 vaccine(s), with the most recent dose received at least 150 days before the study vaccination (Visit 1).
* The study is about 6 months long for each participant.
* Participants will have at least 6 visits (Cohorts 1 and 3) or at least 5 visits (Cohort 2) to the clinic.
* At each clinic visit a blood sample will be taken.
* At least 1 nasal swab will taken.

A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals

Bardstown, KY

Lexington, KY

AMR Knoxville, TN

Medical Affiliated Research Center

Norfolk, VA

AMR Mobile, AL

AMR Tempe, AZ

Dublin, CA

Walnut Creek, CO

BioNTech

The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.

Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen

AstraZeneca

The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.

This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally or can transition to a Continued Treatment for Trial Participants Open-Label Extension study.

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

Optimed Research, LTD

Rheumatology

Gastrointestinal Research and Clinical Trial Center of Georgia

Omaha, NE

Shreveport, LA

New Orleans, LA

Tyler, TX

New Port Richey, FL

Omega Research Orlando, LLC

Orlando, FL

Tampa, FL

Victoria Gastroenterology

San Antonio, TX

Clinical Protocols Department

Ophthalmology, Ogden, UT

United Clinical Research - Los Alamitos

Smidt Heart Institute

Los Angeles, CA

UCSF Center for Colitis and Crohn's Disease

Medicina Interna - Ensayos Clinicos

Clinical Research Unit

Ematologia Clinical Trials Unit

Bydgoszcz, Poland

Department of Gastroenterology

Gastroenterology

Complejo Asistencial Dr. Sotero Del Rio - Investigaciones Medicas SSMSO Office

The Helmsley Cancer Center - Oncological Day Hospital

Cardiology Clinical Trials Unit

AbbVie

The study consists of 4 sub-studies, as follows:

* Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991;
* Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991;
* Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab;
* Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab.
* OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease

Find clinical trials for COVID-19 in Louisville, KY

Related conditions:

COVID-19 trials near Louisville, KY, USA:

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

Study to Evaluate Safety and Immunogenicity of COVID-19 Vaccine in Children 6 Months to < 12 Years (COVID-19)

A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals

Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA)

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis (COMMAND)

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease (FORTIFY)

Find clinical trials for COVID-19 in .css-epvm6{white-space:nowrap;}Louisville, KY

Related conditions:

COVID-19 trials near Louisville, KY, USA:

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

Study to Evaluate Safety and Immunogenicity of COVID-19 Vaccine in Children 6 Months to < 12 Years (COVID-19)

A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals

Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA)

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis (COMMAND)

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease (FORTIFY)

Find clinical trials for COVID-19 in Louisville, KY