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RNA Virus Infections clinical trials

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NCT ID: NCT04664075 Completed - Covid19 Clinical Trials

Predicting Severity and Disease Progression in Influenza-like Illness (Including COVID-19)

PREDICT-ILI
Start date: January 25, 2021
Phase:
Study type: Observational

Respiratory infections such as colds, flu and pneumonia affect millions of people around the world every year. Most cases are mild, but some people become very unwell. Influenza ('flu') is one of the most common causes of lung infection. Seasonal flu affects between 10% and 46% of the population each year and causes around 12 deaths in every 100,000 people infected. In addition, both influenza and coronaviruses have caused pandemics in recent years, leading to severe disease in many people. Although flu vaccines are available, these need to change every year to overcome rapid changes in the virus and are not completely protective. This study aims to find and develop predictive tests to better understand how and when flu-like illness progresses to more severe disease. This may help to decide which people need to be admitted to hospital, and how their treatment needs to be increased or decreased during infection. The aim is to recruit 100 patients admitted to hospital due to a respiratory infection. It is voluntary to take part and participants can choose to withdraw at any time. The study will involve some blood and nose samples. This will be done on Day 0, Day 2 and Discharge from hospital, and an out-patient follow-up visit on Day 28. The data will be used to develop novel diagnostic tools to assist in rational treatment decisions that will benefit both individual patients and resource allocation. It will also establish research preparedness for upcoming pandemics.

NCT ID: NCT04644484 Completed - Virus Diseases Clinical Trials

A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety

Start date: September 23, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 3, blinded, randomized study of SYN023 compared to a China licensed Human Rabies Immunoglobulin (a Rabies immune globulin from human sources, HRIG) for the prevention of rabies as part of post-exposure prophylaxis (PEP). The trial will enroll the World Health Organization (WHO) Category III rabies exposure subjects. The subject's death and rabies data will be reviewed by Data and safety monitoring board (DSMB) to confirm the safety. Besides, rabies vaccine would be administered after Study Drug in each group. This trial is proposed to further the licensure of SYN023 to provide an effective PEP alternative available to those exposed persons who need such a product. A placebo-controlled rabies trial is unethical thus HRIG is selected as the control group. Rabies immune globulin from equine and human sources (HRIG) have been evaluated in many trials and HRIG is the standard of care in China.

NCT ID: NCT04627623 Recruiting - Covid19 Clinical Trials

Prevalence and Risk Factors of COVID-19 in the Upper Silesian Agglomeration

EpiSARS2
Start date: June 22, 2020
Phase:
Study type: Observational

Project is designed as a comprehensive population-based epidemiological study in Upper-Silesian Conurbation (Poland) aiming at: 1. analysis of available data on incidence and mortality due to COVID-19 and 2. estimation of the occurrence of viral infection SARS-CoV-2 as revealed by the results of serological test (ELISA: IgM, IgG), with assessment of risk factors. The project's objectives are: to assess incidence and mortality due COVID-19 according to sex, age and coexisting diseases; to determine the level of potential "underdiagnosis" of the magnitude of COVID-19 mortality using vital statistics data for Upper-Silesian Conurbation; to assess the prevalence of SARS-CoV-2 based on the level of seropositivity in Upper-Silesian Conurbation; to identify host-related and environmental risk factors if the infection. Analysis of existing data will include monthly records on incidence and mortality over the period 01.01.2020-31.12.2020 and comparison of the findings with the monthly records of 2018 and 2019, for the same population. Cross-sectional epidemiological study will be located in three towne (Katowice, Sosnowiec, Gliwice). In each town a representative age-stratified sample of 2000 subjects will undergo questionnaire assessment and serological examination performed by serological test. The project corresponds with analogous population-based studies on COVID-19 in a number of countries and responds to the WHO recommendation in that field.

NCT ID: NCT04517682 Completed - Clinical trials for RNA Virus Infections

COVID-19 and SARS-CoV-2 Detection in Saliva

Start date: May 21, 2020
Phase:
Study type: Observational

This study aims to validate the use of human saliva as a substrate for an assay to detect SARS-CoV-2 and define accuracy, analytical sensitivity and specificity of the TaqPath RT-PCR test.

NCT ID: NCT04476979 Completed - Clinical trials for Respiratory Tract Infections

Comparison of Tocilizumab Plus Dexamethasone vs. Dexamethasone for Patients With Covid-19

TOCIDEX
Start date: July 16, 2020
Phase: Phase 2
Study type: Interventional

The overall objective of the study is to determine the therapeutic effect and tolerance of Tocilizumab combined with Dexamethasone in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Dexamethasone alone or Dexamethasone +Tocilizumab administration to patients enrolled in the CORIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care (including Dexamethasone) treated patients

NCT ID: NCT04380701 Active, not recruiting - Virus Diseases Clinical Trials

A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019 in Healthy and Immunocompromised Adults

Start date: April 23, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This trial has two parts. Part A and Part B. Due to changes in the overall clinical development plan, Part B will no longer be conducted. The objectives originally described for Part B have been implemented in the ongoing development via a pivotal Phase I/II/III trial BNT162-02/C4591001 (ClinicalTrials.gov NCT: 04368728). Part A is for dose ranging of four different vaccines (BNT162a1, BNT162b1, BNT162b2, and BNT162c2) which will be undertaken with dose escalation and de-escalation plus the evaluation of interim dose levels. It also includes dose ranging in older participants. The vaccines BNT162a1, BNT162b1, BNT162b2, and BNT162c2 will be administered using a Prime/Boost (P/B) regimen. The vaccine BNT162c2 will also be administered using a Single dose (SD) regimen. Three additional cohorts aged from 18 to 85 years receiving BNT162b2 only. BNT162b2 has entered a Phase II/III evaluation of efficacy, with the intent to support an application for marketing authorization. The dosing regimen under investigation is two BNT162b2 doses given ~21 d apart.

NCT ID: NCT04376034 Recruiting - COVID19 Clinical Trials

Convalescent Plasma Collection and Treatment in Pediatrics and Adults

Start date: April 16, 2020
Phase: Phase 3
Study type: Interventional

This is a prospective study, involving contacting potential plasma donors and the use of their plasma to help fight off infections of those suffering from COVID19 in accordance to collection guidelines for plasma and FDA IND requirement. This study will include up to 240 participants potentially receiving convalescent plasma and up to 1000 potential donors. There are 3 basic arms to the study: mild, moderate and severe/critical severity. All 3 severity groups are eligible for enrollment, but mild severity will not be given plasma unless there is progression. Moderate severity will given up to 1 unit of plasma and severe/critical severity up to 2 units. There is no placebo group, however given the excepted issues of shortages of plasma, intention to treat will be used for analysis.

NCT ID: NCT04367740 Completed - Virus Diseases Clinical Trials

ScreenNC, a Study to Determine the Number of Asymptomatic Individuals Who Have Antibodies to the Virus That Causes COVID-19

Start date: April 28, 2020
Phase:
Study type: Observational

Purpose: To determine the number of asymptomatic individuals who have antibodies to SARS-CoV-2, the virus which causes COVID-19

NCT ID: NCT04365101 Active, not recruiting - Pneumonia Clinical Trials

Natural Killer Cell (CYNK-001) Infusions in Adults With COVID-19

CYNKCOVID
Start date: May 13, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in patients with moderate COVID-19 disease.

NCT ID: NCT03776994 Active, not recruiting - Clinical trials for Nervous System Diseases

Venezuelan Equine Encephalitis Monovalent Virus-Like Particle Vaccine

VEEV
Start date: July 17, 2018
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to evaluate the safety and immunogenicity of non-adjuvanted and adjuvanted monovalent VEE VLP Vaccine in healthy adults (ages 18-50 years) when administered via intramuscular (IM) injection at escalating doses of 2 μg, 10 μg, and 20 μg as a 2-dose primary series (Day 0, Day 28) with a Day 140 booster dose. The secondary objective of the study is to evaluate immunogenicity of the vaccine at the aforementioned time points