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Influenza, Human clinical trials

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NCT ID: NCT06207929 Recruiting - COVID-19 Clinical Trials

Wearable Assisted Viral Evidence (WAVE) Study A Decentralized, Prospective Study Exploring the Relationship Between Passively-collected Data From Wearable Activity Devices and Respiratory Viral Infections

WAVE
Start date: January 21, 2024
Phase:
Study type: Observational

The goal of this decentralized, observational study is to enroll and observe adults in the contingent United States during the 2023-2024 flu season. The main study objectives are to create a dataset of paired wearable data, self-reported symptoms, and respiratory viral infection (RVI) from PCR testing during the 2023-2024 flu season and to develop algorithm that is able to accurately classify asymptomatic and symptomatic RVI and understand the algorithm's performance metrics.

NCT ID: NCT06205641 Recruiting - Influenza A Clinical Trials

A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Influenza A

Start date: January 2024
Phase: N/A
Study type: Interventional

This study is a prospective, multicenter, randomized controlled trial and aims to evaluate efficacy and safety of Xuanfei Baidu Granule in the treatment of influenza A. This study plans to enroll 584 subjects. The subjects will be randomly divided into 4 groups according to the ratio of 1:1:1:1, and they will be treated with Xuanfei Baidu Granule Placebo, Xuanfei Baidu Granule, Xuanfei Baidu Granule combined with Baloxavir Marboxil tablet.1 bag of Xuanfei Baidu Granule and Xuanfei Baidu Granule Placebo in the morning and evening, and take with boiling water for 5 days. Baloxavir Marboxil Tablet was taken orally 2 tablets, once a day for 1 day. The subjects were visited every day for 7 days after enrollment.

NCT ID: NCT06191393 Recruiting - Clinical trials for SARS-CoV-2 Infection

SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings

Start date: November 20, 2023
Phase: N/A
Study type: Interventional

The Metrix COVID/Flu Test will be evaluated for use in Point-of-Care and Non-Laboratory settings in a home testing environment utilizing the clinical study design described herein. The study will take place in simulated home environments which will be set up within or near active clinical settings (e.g., urgent care facilities). This will be a prospective study conducted at three or more investigational sites located within the United States for the clinical validation of the Metrix COVID/Flu Test for the differential detection of SARS-CoV-2, Influenza A, and Influenza B in AN swab or saliva samples. Additional sites may be added to the study in order to meet minimum subject/sample enrollment requirements and geographic prevalence of respiratory virus infections. One or more investigational sites outside of the US (at which participants are required to be fluent in English) may also be included in the study depending on enrollment needs and geographical/seasonal prevalence of respiratory virus infections. Comparator testing will be performed to determine the infection status of each sample for comparison to results generated by the candidate test. The primary comparator for the study will be an FDA-cleared assay for the detection of SARS-CoV-2, Flu A, and/or Flu B.

NCT ID: NCT06183229 Recruiting - Influenza Clinical Trials

Cycloferon for Post-exposure Prophylaxis of Acute Respiratory Viral Infections and Influenza

Start date: September 15, 2023
Phase: Phase 3
Study type: Interventional

Influenza and other acute respiratory viral infections remain practically uncontrollable diseases due to the high variability of the antigenic structure of influenza viruses and the heterogeneity of pathogens of acute respiratory infections. Therefore, for the prevention and treatment of influenza, acute respiratory viral infections and herpes infections, it is relevant to develop drugs - immunomodulators that mobilize the reserves of nonspecific and specific immune systems and enhance the effects of these systems against the pathogens. The drug CYCLOFERON, 150 mg, enteric-coated tablets, contains the active substance meglumine acridone acetate, which is an interferon inducer. Interferons are the most important system of innate immunity, which has antiviral and immunomodulatory effects, and can protect the body from infection with a virus, and in case of infection, fight the causative agent of the disease. The planned clinical trial of the efficacy and safety of the drug CYCLOFERON in the dosage form of a tablet will study its ability to prevent influenza and other respiratory viral infections in adults who have already had close contact with patients with manifest disease.

NCT ID: NCT06179446 Recruiting - Influenza Clinical Trials

A Study to Learn How Safe, Tolerable and Capable of Producing an Immune Response is, a Modified RNA Vaccine Against Pandemic Influenza

Start date: December 13, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to learn about the safety and effects of the study vaccine for the possible prevention of influenza. Influenza is a disease that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. The study vaccine is called Pandemic Influenza modRNA (pdmFlu) Vaccine. This study is seeking for participants who are: - between the age of 18 to 49 years old. - willing and able to follow with all scheduled visits, treatment plan, laboratory tests, lifestyle changes, and other study procedures. - healthy as confirmed by medical history, physical examinations, and the study doctor. - capable of signing informed consent. Participants will receive either: - the pdmFlu Vaccine, - a licensed Influenza Vaccine (QIV) - a placebo. A placebo does not have any medicine in it but looks just like the study medicine. Participants will not know which vaccine they receive. Participants will receive the study vaccines as a single shot in the arm at day 1 and at day 21. The study will compare participant experiences to help understand if the pdmFlu Vaccine is safe and effective. Participants will take part in this study for up to 8 months. During this time, the participants will receive the study vaccine and take part in follow-up visits.

NCT ID: NCT06178991 Recruiting - COVID-19 Clinical Trials

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.

Start date: December 20, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to understand the safety and effects of a combined influenza and COVID-19 vaccine. This combined vaccine is compared to separate vaccines for the protection against influenza and SARS-CoV-2. Influenza and COVID-19 are diseases that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. Giving both influenza and COVID-19 vaccines together against influenza and SARS-CoV-2 could provide great benefits to both patients and caregivers in terms of simple and easy care. Around 9000 participants will be assigned into 1 of 4 vaccination groups (Group A, B, C or D) by chance. Cohort 1: Around 4500 participants will be assigned by chance to one of the following: - Group A:Influenza and COVID-19 combination A vaccine, given at the same time in the right arm and placebo (an injection consisting of just salt water and no medicines in it) in the left arm. - Group B: COVID-19 vaccine, given at the same time to the right arm and licensed influenza vaccine in the left arm. Cohort 2: Around 4500 participants will be assigned by chance to one of the following: - Group C: Influenza and COVID-19 combination B vaccine, given at the same time in the right arm and placebo in the left arm. - Group D: COVID-19 vaccine, given at the same time in the right arm and licenced influenza vaccine in the left arm. All participants will receive 2 injections as per their assigned study group at Visit 1. The participants will be followed for about 6 months. During this time, the study will compare participant experiences when they receive a combined vaccination to when they receive separate vaccinations. This will help understand if the study medicine is safe.

NCT ID: NCT06175611 Recruiting - SARS-CoV2 Infection Clinical Trials

Clinical Performance Study for EDAN's COVID-19/Flu A/Flu B/RSV Test Kits on Subjects Suspected of Respiratory Infection

Start date: December 10, 2023
Phase:
Study type: Observational [Patient Registry]

The primary objective of this clinical performance study is to evaluate and further validate the clinical performance of: 1. ClariLight Influenza A/B & SARS-CoV-2 test kits and 2. ClariLight Influenza A/B & RSV test kits, for the qualitative detection and differential diagnosis of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) present in anterior nasal and oropharyngeal swab, in combination with an automated molecular diagnostic analyzer and sample collection tube by comparing them against a CE marked, in-vitro diagnostic device, used in the standard of care.

NCT ID: NCT06168019 Recruiting - COVID-19 Clinical Trials

Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India

ICOPE
Start date: December 26, 2023
Phase:
Study type: Observational

This study will be conducted as a prospective cohort study, enrolling all eligible women in their first trimester of pregnancy during a baseline visit during week 6-13 of pregnancy at Government Medical College Hospital, Nagpur. The Hospital provides primary, secondary, and tertiary care and the obstetric department delivers about 10,000 babies a year. The hypothesis is that co-infection of other respiratory viruses (ORV), particularly COVID-19 and Influenza increases the risk of adverse pregnancy outcomes in mothers and babies and could address the current standard of care in India to not vaccinate pregnant women during pregnancy, by either encouraging vaccination against both viruses before planning a pregnancy or during pregnancy based on global data supporting the safety of this strategy.

NCT ID: NCT06161454 Recruiting - Influenza Clinical Trials

Xofluza-Wearables Feasibility-Study

Start date: December 14, 2023
Phase: Phase 4
Study type: Interventional

The goal of this prospective, interventional, single-center study is to assess whether the early detection of Influenza with smartwatch algorithms and alerting, rapid testing, and subsequent Baloxavir treatment demonstrate better post-infection outcomes versus publicly available- and Centers for Disease Control (CDC)-derived national statistics for equivalent household populations as well as pediatric kidney, heart, liver, lung transplant recipients and waitlisted patients.

NCT ID: NCT06160531 Recruiting - Influenza A Clinical Trials

Influenza Viral Challenge Study of CC-42344 in Healthy Participants

Start date: November 25, 2023
Phase: Phase 2
Study type: Interventional

Participants in this study will be given either CC-42344 (one of two dose levels) or placebo orally for 5 days after receiving an influenza (flu) challenge virus. Participants will not know whether they are getting placebo or CC-42344. The amount of virus in nasal samples will be measured over time. Side effects and pharmacokinetics (the amount of CC-42344 in blood) will also be measured.