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Virus Diseases clinical trials

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NCT ID: NCT04786444 Completed - Clinical trials for Chikungunya Virus Infection

Study to Demonstrate Consistency of Three Lots of a Live-attenuated Chikungunya Virus Vaccine Candidate in Healthy Adults

Start date: February 22, 2021
Phase: Phase 3
Study type: Interventional

This was a prospective, randomized, double-blinded, multicenter Phase 3 clinical study investigating three Lots of VLA1553 at the final dose. Overall 409 healthy subjects aged 18 to 45 years were randomized into the study.

NCT ID: NCT04782427 Completed - Covid19 Clinical Trials

COVID-19 Infections and Mortality in Long-term Care Facilities During the First Wave

Start date: January 1, 2021
Phase:
Study type: Observational

The medical charts of all COVID-19 cases (n=1200) from 17 long-term care facilities in Montreal, Canada will be reviewed, to compare patients who survived to patients who did not survive. Through multilevel logistic regression, the risk of death will be estimated for institutional predictors of mortality, while controlling for individual risk factors. Individual covariates include clinical features (age, sex, Charlston comorbidity index, SMAF autonomy score, severity criteria) and medical treatments (IV fluids, anticoagulation, oxygen, regular opiates, corticosteroids). Aggregate covariates include epidemiological data (attack rates, timing of outbreak) and institutional characteristics (number of beds, air exchange per hour, presence of a dedicated COVID-19 unit at the time of outbreak, staff compliance to infection control measures, staff infection rates, understaffing, proportion of semi-private rooms, proportion of wandering wards and other special units).

NCT ID: NCT04777747 Completed - Clinical trials for Bacterial Infections

The Role of Lactate in Viral and Bacterial Infection

Start date: January 1, 2021
Phase:
Study type: Observational

Acute upper respiratory tract infection(AURI) is common in children, and viral infection is the main cause. However, several children with viral infection are easy to suffer from secondary bacterial infection, and the mechanism is unclear.

NCT ID: NCT04772469 Completed - HIV Infections Clinical Trials

Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men

Start date: March 22, 2021
Phase: N/A
Study type: Interventional

This is a randomized controlled trial to test a combination behavioral and biomedical interventions to improve the HIV prevention and care cascades in a population of mobile men in a high priority setting (fishermen in Kenya). The intervention strategy is to recruit and train highly socially-connected men to distribute HIV self-tests and provide linkage support to men in their close social networks. The study will determine whether this social network-based approach along with small financial incentives in the form of transport vouchers can increase men's self-testing, linkage to and uptake of ART and PrEP after self-testing, virologic suppression at 6 months (for those initiating ART) and PrEP adherence (for those initiating PrEP) at 6 months. The study includes a longitudinal qualitative and mixed methods (quantitative and qualitative assessments) to identify the pathways of intervention action, and understand how the social network-based approach with support for linkage affects testing and ART and PrEP uptake and retention in men.

NCT ID: NCT04772170 Recruiting - Influenza Clinical Trials

Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

Start date: October 23, 2023
Phase:
Study type: Observational

Background: Respiratory viruses circulate throughout the year and around the globe. Wearable and sensor devices, like smartwatches, may be able to help monitor infectious diseases. Researchers want to use them to learn how respiratory viruses affect people in different ways. Objective: To use digital devices to collect data from participants in challenge studies that could indicate subtle changes in health during an infection that might otherwise go unnoticed. Eligibility: Healthy adults who have enrolled in a challenge study. Design: Participants will stay at NIH for at least 9 days and then they will have outpatient visits. While at NIH, participants will wear a smartwatch at all times. It will record data like temperature, heart rate, breathing rate, and movements. Participants will have 2 smartphones. One will be recording at all times to listen for coughing. Participants will use the other smartphone to check their vital signs. They will collect data like heart rate, temperature, and the level of oxygen in the blood every 4 hours during the daytime. Participants will perform tasks every 4 hours during the daytime. They will record themselves coughing, breathing in deeply, and reading aloud. They will take pictures and videos of their face. A bedside sensor will record participants while they sleep. It will record heart rate and breathing rate. It will also look at sleep activity, such as movements participants make during sleep and how deeply they sleep. Participants sharing the same room will be exposed to the same challenge virus. For outpatient visits, participants will use one smartphone and the smartwatch to complete the above tasks. Participation will last from 10 weeks to 1 year.

NCT ID: NCT04769167 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Congenital Heart Anomaly Risk in Maternal Enteroviral Infection and Diabetes

CHARMED
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

Beyond EV-B, there are clinical observations to implicate other viruses in birth defects, including CHD. Since the Rubella epidemic of 1960s', however, viruses have received little attention and certainly no comprehensive study, especially using next generation sequencing (NGS), has been undertaken in this context. The current pandemic as well as those caused by Zika, influenza, Ebola and Lassa Fever (among many) have shown pregnant women and their baby are at high risk. Therefore, an open-minded approach is warranted when considering the role of maternal viral infections in CHD. Even less is known about maternal immune response, such as antibody production, to these viruses. The investigator's goal is to answer the above gaps in knowledge. The investigators propose to do that using two different approaches; one retrospective (analysis of samples in two existing, large biorepositories) and the other prospective. The investigator's have created a multi-disciplinary team to bring together the needed expertise from individuals who have overlapping and vested interest in this project. The investigator's specific aim is to examine the diversity of the gut virome in non-pregnant and pregnant women with and without diabetes, with special emphasis on known cardiotropic viruses (those with tropism for cardiac tissues). This study is seen by the investigator's as the first step prior to a larger prospective multi-institutional study to specifically assess the linkage between the maternal virome and CHD pathogenesis.

NCT ID: NCT04768517 Recruiting - Clinical trials for Hepatitis C Virus Infection

HCV Reinfection in in HIV/HCV-coinfected Patients Achieving SVR by Antiviral Therapy

Start date: February 9, 2021
Phase:
Study type: Observational

Chronic hepatitis C virus (HCV) infection remains a health burden in people living with human immunodeficiency virus (HIV). Interferon (IFN)-based therapy is the treatment of choice for HCV infection for HIV coinfected patients in earlier years. However, the treatment responses are far from ideal and the treatment-emergent adverse events (AEs) are frequently encountered. Based on the excellent efficacy and safety, IFN-free direct acting antivirals (DAAs) have been the mainstay of therapy for HCV. Furthermore, the world health organization (WHO) has set the goal of global HCV elimination by 2030. The microelimination of HCV among HIV/HCV-coinfected patients is also listed as the prioritized target by WHO. Although the overall treatment response has improved dramatically during the past 5-10 years, several studies have indicated the HIV/HCV-coinfected patients had high risks of reinfection following successful antiviral treatment. The risk of HCV reinfection was reported to be 24.6% among HIV-positive men who have sex with men (MSM) in Austria, German, France and the United Kingdom who attained sustained virologic response (SVR) by IFN-based therapy. Two recent studies from Canada showed that the incidence of HCV reinfection in HIV-positive patients was higher that HIV-negative patients (3.44 vs. 1.13 per 100 person-year; 2.56 vs. 1.12 per 100 person-year). In Taiwan, 14.1% of the HIV-positive patients had HCV reinfection following treatment-induced or spontaneous viral clearance, resulting an incidence of 8.2 per 100 person-year with a total of 218.3 person-years of follow-up for these patients. Because data regarding to the HCV reinfection in HIV-positive patients are still limited, where a more comprehensive assessment of HCV reinfection is important based on the perspectives of HCV microelimination among HIV-positive patients in Taiwan, the investigators thus aim to conduct a long-term, large-scale cohort study to assess the risk of HCV reinfection in HIV-positive patients achieving SVR after IFN-based or IFN-free therapies, and to assess the factors associated with different risks of reinfection in these patients.

NCT ID: NCT04758962 Completed - Virus Diseases Clinical Trials

A Study of the Safety of and Immune Response to Varying Doses of a Vaccine Against COVID-19 in Healthy Adults

Start date: February 15, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, reactogenicity and immune response of a self-amplifying mRNA (SAM) lipid nanoparticle (LNP) platform with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Spike antigen (CoV-2 SAM [LNP] vaccine) in ascending doses when administered intramuscularly (IM) on a 0,1-month schedule to healthy adults 18 to 50 years of age. There will be no administration of escalated doses of the study vaccine.

NCT ID: NCT04757272 Completed - Clinical trials for Corona Virus Infection

Does Hepatitis C Management Protect Egyptian Population Against Severe Corona Virus Disease-2019?

Start date: May 1, 2020
Phase:
Study type: Observational

Modulation of the renin angiotensin system by the chronic hepatitis C virus treatment either by (Daclatasvir and Sofosbuvir), (Daclatasvir and Sofosbuvir plus Ribavirin), or (Ribavirin and Interferon) protocols could give an explanation for the low incidence of COVID-19 among Egyptian population. Adding it may play a role in COVID 19 prophylaxis.

NCT ID: NCT04754633 Completed - Covid19 Clinical Trials

Comparison of Chest CT Findings Related to COVID-19 With RSNA and BSTI Guidelines

Start date: July 1, 2020
Phase:
Study type: Observational

To present the first admission chest computed tomography (CT) findings of patients followed up with a diagnosis of COVID-19, and to compare the two classification systems by evaluating these findings according to the BSTI and RSNA guidelines.