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Influenza, Human clinical trials

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NCT ID: NCT06175468 Not yet recruiting - COVID-19 Clinical Trials

Evaluate the Efficacy and Safety of "Formosa 1-Breath Free (NRICM101) " in Subjects With the Symptoms of COVID-19 or Influenza-like Disease

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

"Formosa 1-Breath Free (NRICM101) " has been widely known in Taiwan to treat COVID-19. However, there is no phase III pivotal clinical trial of "Formosa 1-Breath Free (NRICM101) " . In order to obtain scientific, standardized, and comparable clinical results, the study will be implemented to evaluate the efficacy of safety of "Formosa 1-Breath Free (NRICM101) ". The objective of the study was used the product which be provided by Tian-I Pharmaceutical Co. Ltd. to evaluate the efficacy and safety of the subjects with the symptoms of COVID-19 or Influenza-like after taking "Formosa 1-Breath Free (NRICM101) ". This study is a randomized, double-blind, parallel controlled clinical trial. The study consisted of 3 cycles: screening period, treatment period (5 days) and follow-up period. The treatment of this study is divided into two groups: The test drug is Formosa 1-Breath Free (NRICM101) granule 5g/bag, 3 times a day;The control drug is the placebo (dummy) 5g/bag, 3 times a day. The sample size in the study is at least 150 people who can be evaluated, and the dropout rate of the test is 10-15%. The estimated sample size is around 170 people. After signing the ICF, vital signs (sitting blood pressure, pulse rate, SpO2, respiratory rate and body temperature), physical examination, chest X-ray, and laboratory test will be checked in screening period. Only subjects with clinically acceptable and following the inclusion and exclusion criteria will eligible to enroll in this study. Compliance will be assured by administration of the study drug under the supervision of the investigator or his deputy. Subjects will be free to withdraw at any time without stating any reason. Data will be analyzed from those subjects who complete the entire study; however, the case report forms and the final study report should include reasons for withdrawals and any necessary treatment.

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: NCT06163677 Withdrawn - COVID-19 Clinical Trials

A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza.

Start date: January 17, 2024
Phase:
Study type: Observational

The main purpose of this study is to understand: - the symptoms of COVID-19 or influenza - health-related outcomes of people with COVID-19 or influenza - the effects of vaccines in people with COVID-19 or influenza. This study will take in participants who are: - 18 years or older - reported to have symptoms with lab tests that have confirmed illness. The lab tests can be tested at any of Walgreens pharmacy COVID-19 or influenza test sites. The study will collect vaccine history information from participants who are ready to take part in the study. Participant will be emailed a form with questions about their health related to COVID-19 or influenza during twelve follow-ups over a 6-month period.

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.

NCT ID: NCT06141824 Completed - COVID-19 Clinical Trials

Performance Evaluation of the Lucira COVID-19 & Flu Test

Start date: October 11, 2022
Phase: N/A
Study type: Interventional

The Lucira COVID-19& Flu Test is a single use (disposable) RT-LAMP test kit intended for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B viral RNA in anterior nasal swab specimens. The test consists of a nasal swab, a sample vial the nasal swab sample is placed in the sample vial, containing the sample buffer, and the test unit, which detects whether SARS-CoV-2, Influenza A, and Influenza B virus is present within the specimen during an acute infection. The Lucira test uses a proprietary, molecular based process to detect the presence of SARS-CoV-2, Influenza A, or Influenza B virus. The purpose of this study is to investigate the Lucira COVID-19 & Flu Test for the in vitro qualitative detection and differentiation of RNA from SARS-CoV-2, Influenza A, and Influenza B in nasal swab specimens from patients suspected of COVID-19 or Influenza A or Influenza B. The primary objective is to test at least 1000 self-collected nasal swab samples and to confirm the Lucira COVID-19 & Flu Test provides similar accuracy to a high complexity lab molecular diagnostic RT-PCR assay(s) with known high sensitivity for detecting SARS-CoV-2, Influenza A, and Influenza B virus.

NCT ID: NCT06141655 Recruiting - Influenza Clinical Trials

HD vs SD Quadrivalent Influenza Vaccine in Adults Aged 65 to 79 Years in Galicia

Start date: October 26, 2023
Phase: Phase 4
Study type: Interventional

This pragmatic randomized trial is designed to evaluate the relative vaccine effectiveness of QIV-HD vs. QIV-SD in reducing the risk of hospitalization for influenza or pneumonia in adults 65-79 years of age in Galicia during 2023/2024 and 2024/2025 seasons.

NCT ID: NCT06127108 Completed - COVID-19 Clinical Trials

Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel

Start date: November 14, 2023
Phase: N/A
Study type: Interventional

The study is designed as a prospective, multicentric, clinical study to investigate the positive percent agreement (PPA) and negative percent agreement (NPA) of the Panbio™ COVID-19/Flu A&B Panel using anterior nasal swab specimens tested directly, relative to the comparator methods, Roche cobas® SARS-CoV-2 (K231306) and Quidel Lyra® Influenza A+B Assay(K230236) (RT-PCR) in symptomatic patients suspected of respiratory viral infection by a healthcare provider.

NCT ID: NCT06125717 Completed - Influenza Clinical Trials

Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAP

Start date: July 2, 2022
Phase: Phase 1
Study type: Interventional

A Phase 1, Randomized, Rater and Participant Blinded Placebo Controlled Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of a Standard and a Fractional Dose of H1 Influenza Vaccine Delivered by VX-103 (a MIMIX Microneedle Array Patch (MAP) System) in Healthy Adults ≥18-39 Years of Age

NCT ID: NCT06125691 Recruiting - Influenza, Human Clinical Trials

Safety and Immunogenicity First-in-human Dose-ranging Study of Self-Amplifying RNA Seasonal Influenza Vaccine in Adults

Start date: January 22, 2024
Phase: Phase 1
Study type: Interventional

This is a safety and Immunogenicity first-in-human dose-ranging study of self-amplifying RNA Seasonal Influenza Vaccine (ARCT-2138) in adults.