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Virus Diseases clinical trials

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NCT ID: NCT05846360 Completed - Clinical trials for Respiratory Viral Infection

The Technical and Operational Performance of the QuidelOrtho Savanna RVP4 Analyzer

Start date: May 5, 2023
Phase:
Study type: Observational

The purpose of this study is for the research team to become familiar with and evaluate the technical and operational performance of the QuidelOrtho Savanna RVP4 analyzer by testing 120 archived specimens that were previously tested at the Wisconsin State Laboratory of Hygiene (WSLH) by RT-PCR and multiplex respiratory pathogen panel within the last year.

NCT ID: NCT05841342 Recruiting - Clinical trials for Secondary Hemophagocytic Lymphohistiocytosis

Prospective Study of Immune Function and PD-1 Antibody Therapy Efficacy Predictors on CAEBV and EBV-HLH Patients

Start date: October 1, 2022
Phase:
Study type: Observational

This prospective case-control study aims to evaluate the immune function and find PD-1 antibody efficacy predictors on Chronic Active Epstein-Barr Virus Infection and Epstein-Barr virus-associated hemophagocytic lymphohistiocytosis by detecting lymphocyte subsets proportions in peripheral blood mononuclear cells and the positive proportion of PD-1, PD-L1 and other indicators in each lymphocyte subsets in healthy people and patients using flow cytometry before and after the initial PD-1 therapy.

NCT ID: NCT05817422 Active, not recruiting - Clinical trials for Marburg Virus Disease

Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults

Start date: October 19, 2023
Phase: Phase 2
Study type: Interventional

A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults

NCT ID: NCT05813691 Not yet recruiting - Hepatitis C Clinical Trials

Epidemiology of Occult Hepatitis C Virus Infection in Patients Born Before 1969 in the Hospital Setting: a Spontaneous Opportunistic Screening Initiative.

ERADIcATE
Start date: April 10, 2023
Phase:
Study type: Observational

The goal of this monocentric prospective observational study is to evaluate the prevalence of unknown hepatitis C virus chronic infection in general population born before january 1st 1968 in Italy. The main questions it aims to answer are: what is the prevalence of hepatits C virus infection in general population born before January 1st, 1968? What rare the characteristics of these patients compared to the general population? What is the prevalence of patients tested HCV positive who are referred to the Hepatology Outpatient Clinic for further evaluation? What is the prevalence of patients with HCV infection detected during the study and treated with direct antiviral agents during follow up? Participants will be tested with a point of care screening test (Meridian, Bioscience) able to detect anti-HCV antibodies to detect the presence of antibodies against HCV.

NCT ID: NCT05797246 Recruiting - Neoplasms Clinical Trials

Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP)

Start date: August 2, 2023
Phase: Phase 2
Study type: Interventional

Background: Recurrent respiratory papillomatosis (RRP) is a rare disease that causes wart-like growths in the airways. These growths come back when removed; some people may need 2 or more surgeries per year to keep their airways clear. Better treatments are needed. Objective: To see if a drug called bevacizumab can reduce the number of surgeries needed in people with RRP. Eligibility: People aged 18 and older with recurrent RRP; they must need surgery to remove the growths in their airways. Design: Participants will be screened. Their ability to breathe and speak will be evaluated. They will have an endoscopy: a flexible tube with a light and camera will be inserted into their nose and throat. They will have a test of their heart function and imaging scans of their chest. Participants will have surgery to remove the growths in their airways. Bevacizumab is given through a small tube placed in a vein in the arm. After the surgery, participants will receive 11 doses of this drug: every 3 weeks for 3 doses, and then every 6 weeks for 8 more doses. They will come to the clinic for each dose; each visit will be about 8 hours. Tissue samples of the growths will be collected after the second treatment; this will be done under general anesthesia. Participants may undergo apheresis: Blood will be drawn from a needle in an arm. The blood will pass through a machine that separates out the cells needed for the study. The remaining blood will be returned to the body through a second needle. Follow-up will continue for 1 year after the last treatment.

NCT ID: NCT05794412 Active, not recruiting - Clinical trials for SARS-CoV-2 Infection

Mucosal Immunity: Influence on Infectious Viral Load: a Prospective Observational Study

MIViral
Start date: January 10, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about the influence of pre-existing mucosal immunity, i.e. antibodies and immune cells that are present at the nasal mucosa before infection, on the infectious viral load after infection with SARS-CoV-2, influenza virus and RSV. The investigators will include app. 320 participants which will be followed for up to 17 months. During this time, the investigators will monitor their nasal mucosal antibodies at regular intervals and compare them to their infectious viral load if they are infected with SARS-CoV-2, influenza virus or RSV. Participants are invited to take a test for SARS-CoV-2, influenza virus or RSV in case of respiratory symptoms. If participants are positive the investigators will follow their viral load kinetics by taking nasopharyngeal swabs every 2-3 days. The investigators will also record the duration and strength of the following symptoms: - Cough - Fever - Tired - Sore throat - Difficulty breathing - Respiratory distress - Headache - Loss (or alteration) of smell - Loss (or alteration) of sense of taste - Myalgias - Chills - Subjective fever - Pink sputum (or coughing up blood) - Thoracic pain - Runny nose - Abdominal pain - Nausea - Vomiting - Diarrhea - Constipation - Irritated or watery eyes - Rashes - Other

NCT ID: NCT05771402 Not yet recruiting - Chronic Hepatitis b Clinical Trials

A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (B)

Start date: June 1, 2023
Phase: Phase 4
Study type: Interventional

Hepatitis B virus (HBV) infection is a major public health threat in China. At present, a functional cure, also known as clinical cure or sustained Hepatitis B surface antigen (HBsAg) loss, is recommended as the ideal endpoint of HBV treatment. However, HBsAg loss can be achieved in less than 10% of chronic hepatitis B (CHB) patients treated with current available antiviral drug interferon (IFNα) or nucleos(t)ide analogues (NAs) monotherapy. With the support of the national major special funding for infectious diseases from "11th Five-Year Plan" to "13th Five-Year Plan", we have implemented a pioneer clinical study of sequential combination of IFNα therapy on NAs to treat NAs-treated CHB patients (ie. New Switch Study). This is the world's first clinical trial aiming to functional cure, which increased the rate of HBsAg loss to 15% in the overall population in our study, and to 30-50% among those with lower baseline HBsAg levels. How to further improve the HBsAg loss rate is an urgent issue for us. The key point of achieving functional cure is to reverse the HBV-specific T cell exhaustion and establish the long-term immune control against HBV infection. (Programmed death-1) PD-1/programmed death-ligand 1 (PD-L1) axis blockade has been demonstrated to reinvigorate exhausted CD8+ T cells, and would be a potential strategy to treat chronic HBV infection. In this study, a large multicenter prospective study will be performed to explore the safety and efficacy of a novel combination strategy involving immune checkpoint inhibitor (anti-PD-1 antibody) and IFNα in CHB patients, observe the HBsAg loss rate in NA-treated CHB patients receiving this combination strategy, evaluate the potential of breaking immune tolerance by this strategy, and further assess its efficacy to further improve the clinical cure rate on the basis of New Switch Study. Based on New Switch Study, this study further attempts to reverse T cell exhaustion in CHB patients, explore a novel platform of combination therapy development for clinical cure, and ultimately increase the HBsAg loss rate to higher than 50% in overall patients. The implementation of the project is expected to reduce the burden of HBV infection in China and contribute to the goal of global elimination of hepatitis B and C by 2030 (WHO 2030).

NCT ID: NCT05769816 Not yet recruiting - Chronic Hepatitis b Clinical Trials

A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (A)

Start date: June 1, 2023
Phase: Phase 4
Study type: Interventional

Hepatitis B virus (HBV) infection is a major public health threat in China. At present, a functional cure, also known as clinical cure or sustained Hepatitis B surface antigen (HBsAg) loss, is recommended as the ideal endpoint of HBV treatment. However, HBsAg loss can be achieved in less than 10% of chronic hepatitis B (CHB) patients treated with current available antiviral drug interferon (IFNα) or nucleos(t)ide analogues (NAs) monotherapy. With the support of the national major special funding for infectious diseases from "11th Five-Year Plan" to "13th Five-Year Plan", we have implemented a pioneer clinical study of sequential combination of IFNα therapy on NAs to treat NAs-treated CHB patients (ie. New Switch Study). This is the world's first clinical trial aiming to functional cure, which increased the rate of HBsAg loss to 15% in the overall population in our study, and to 30-50% among those with lower baseline HBsAg levels. How to further improve the HBsAg loss rate is an urgent issue for us. The key point of achieving functional cure is to reverse the HBV-specific T cell exhaustion and establish the long-term immune control against HBV infection. Programmed death-1 (PD-1)/ programmed death-ligand 1 (PD-L1) axis blockade has been demonstrated to reinvigorate exhausted CD8+ T cells, and would be a potential strategy to treat chronic HBV infection. In this study, a large multicenter prospective study will be performed to explore the safety and efficacy of a novel combination strategy involving immune checkpoint inhibitor (anti-PD-1 antibody) in CHB patients, observe the HBsAg loss rate in NA-treated CHB patients receiving this combination strategy, evaluate the potential of breaking immune tolerance by this strategy, and further assess its efficacy to further improve the clinical cure rate on the basis of New Switch Study. Based on New Switch Study, this study further attempts to reverse T cell exhaustion in CHB patients, explore a novel platform of combination therapy development for clinical cure, and ultimately increase the HBsAg loss rate to higher than 50% in overall patients. The implementation of the project is expected to reduce the burden of HBV infection in China and contribute to the goal of global elimination of hepatitis B and C by 2030 (WHO 2030).

NCT ID: NCT05763576 Recruiting - Chronic Hepatitis B Clinical Trials

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection

Start date: April 28, 2023
Phase: Phase 1
Study type: Interventional

This is a first in human (FIH), multi-center, dose-finding, and dose-escalation Phase I clinical study of RO7565020 to investigate the safety and tolerability and to characterize the pharmacokinetics and pharmacodynamics following single and/or multiple doses of RO7565020 in healthy participants and/or virologically suppressed participants with chronic hepatitis B (CHB).

NCT ID: NCT05739474 Recruiting - Influenza Clinical Trials

Tolerability, Safety and Immunogenicity Trial of the Flu-M Tetra Vaccine in Children

Start date: January 19, 2022
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to assess tolerability, reactogenicity, safety and immunogenicity of the Flu-M Tetra vaccine as compared to the VaxigripTetra vaccine in terms of prevention of influenza in children aged 6 months to 17 years old inclusive.