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 clinical setting.

Reparixin add-on Therapy to Std Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia

Office of Clinical Trials

Rocky Mountain Poison & Drug Safety

Clinical Research Department

Department of Cardiovascular Clinical Research

Children's Hospital - Pedriatic Nephrology Department

Dompé

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).

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

Dayton, OH

South Euclid, OH

Clinical Research Centre

Forest Avenue, Richmond, VA

San Pedro Sula, Honduras

Corning Center for Clinical Research

Plano, TX

Boynton Beach, FL

Miami, FL

Corpus Christi, TX

Idaho Falls, ID

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.

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

Bardstown, KY

Medical Affiliated Research Center

Dublin, CA

BioNTech

The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1083 as compared with active control, co-administered licensed influenza and severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) vaccines, in 2 independent age-group sub-study cohorts, healthy adults 65 years and older (Cohort A) and healthy adults 50 to <65 years of age (Cohort B).

A Study of mRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

Morton, IL

Chicago, IL

Cullman, AL

Lenexa, KY

Rochester, NY

Kingwood, TX

Hialeah, FL

Doral, FL

Tucson, AZ

Pomona, CA

Moderna

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

Clinical Research Unit

Shreveport, LA

Tyler, TX

New Port Richey, FL

Orlando, FL

Victoria Gastroenterology

UCSF Center for Colitis and Crohn's Disease

Medicina Interna - Ensayos Clinicos

Department of Gastroenterology

JM Research SC

CHR Citadel - Department of Gyneacology and Obstetrics

Gastroenterology

Cardiology Clinical Trials Unit

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

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:

Reparixin add-on Therapy to Std Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia

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

A Study of mRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

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

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

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

Related conditions:

COVID-19 trials near Louisville, KY, USA:

Reparixin add-on Therapy to Std Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia

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

A Study of mRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

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

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

Find clinical trials for COVID-19 in Louisville, KY