This study is an interventional, randomized, multinational, multicenter, double-blind, phase 2 study with a follow-up period of 90 days.

The intension of this clinical trial is to investigate the long-term sequelae (named Long COVID syndrome; post COVID or PASC) of an infection with Corona Virus Type 2 that has resulted in a condition known as Severe Acute Respiratory Syndrome Corona Virus Type 2 (SARS-CoV-2).

The purpose of this study is to evaluate the efficacy and safety of BC 007 as a treatment for long-lasting COVID-symptoms in patients who were neither intubated nor supported with extracorporeal blood oxygenation (ECMO) during their acute COVID-19 infection.

The study drug acts by neutralizing functional autoantibodies directed against G-protein coupled receptors (GPCRs).

Neutralization of the autoantibodies is expected to induce a beneficial effect on symptoms typically seen in patients with long COVID syndrome.

Functional autoantibodies are proteins belonging to the class of G-type immunoglobulins that can be synthesized by activation of the immune system and can induce various pathogenic activities by binding to one of the extracellular loops of G-proteins (GPCR-AAB).

The study consists of a screening phase of up to 35 days, treatment (two administrations by intravenous infusion at two-week intervals either with the study drug (BC 007) or with placebo (NaCl 0.9%), with an initial follow-up period of 15 days after each administration and an extended follow-up period of 60 days.

Patients are required to visit the study center for follow-up visits at specified intervals.

For the entire study duration of 125 days from screening to the end of the study, 8 site visits are planned.

To Investigate Efficacy, Pharmacodynamics, and Safety of BC 007 in Participants With Long COVID

Klinik für Dermatologie und Venerologie

KIM II Häma/Onko - Studienzentrale KIM II

Berlin Cures

This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase.

A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

Clinical Trial Center

Gothia Forum - Clinical Trial Center

Norristown, PA

Ormond Beach, FL

Ocala, FL

Sunrise, FL

Hollywood, FL

Miami, FL

Palmetto Bay, FL

Port Charlotte, FL

Bradenton, FL

Memory Center

Houston, TX

UCSF Memory and Aging Center

Irvine, CA

San Diego, CA

Clinical Research Center

Clinical Trials Division

Eisai

The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study.

Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).

COVID-19 sub-study:

The purpose of this research sub-study is to explore the immune response following Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination in a subset of subjects on long-term ofatumumab 20 mg sc. Note: Novartis is not supplying the SARS-CoV-2 vaccine.

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

Wellesley, MA

Westerville, OH

Northbrook, IL

Tampa, FL

Clearwater, FL

Pensacola, FL

Boulder, CO

Novartis

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

Medicina Interna - Ensayos Clinicos

Ematologia Clinical Trials Unit

CHR Citadel - Department of Gyneacology and Obstetrics

Bydgoszcz, Poland

Gastroenterology

Department of Gastroenterology

The Helmsley Cancer Center - Oncological Day Hospital

Optimed Research, LTD

Rheumatology

Gastrointestinal Research and Clinical Trial Center of Georgia

Orlando, FL

Omega Research Orlando, LLC

New Port Richey, FL

Omaha, NE

New Orleans, LA

Shreveport, LA

Tyler, TX

Clinical Protocols Department

Victoria Gastroenterology

San Antonio, TX

Ophthalmology, Ogden, UT

JM Research SC

UCSF Center for Colitis and Crohn's Disease

United Clinical Research - Los Alamitos

Smidt Heart Institute

Los Angeles, CA

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

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 Sevilla, AN

Related conditions:

COVID-19 trials near Sevilla, AN, ESP:

To Investigate Efficacy, Pharmacodynamics, and Safety of BC 007 in Participants With Long COVID (BLOC)

A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (Clarity AD)

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS (ALITHIOS)

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;}Sevilla, AN