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NCT ID: NCT04385095 Completed - SARS-CoV-2 Clinical Trials

Trial of Inhaled Anti-viral (SNG001) for SARS-CoV-2 (COVID-19) Infection

Start date: March 16, 2020
Phase: Phase 2
Study type: Interventional

SNG001 is an inhaled drug that contains a antiviral protein called interferon beta (IFN-β). IFN-β in produced in the lungs during viral lung infections. It has been shown that older people and people with some chronic diseases have an IFN-β deficiency. Many viruses inhibit IFN-β as part of their strategy to evade the immune system. Addition of IFN-β in vitro protects lung cells from viral infection. IFN-β protects cells against the MERS and SARS coronaviruses (close relatives of SARS-CoV-2, the virus that causes COVID-19). SNG001 is an inhaled formulation of interferon beta-1a it is currently in Phase II clinical trials for COPD patients. Synairgen has conducted randomised placebo controlled clinical trials of SNG001 involving >200 asthma and COPD patients. These trials have shown that SNG001 has: - been well tolerated during virus infections - enhanced antiviral activity in the lungs (measured in sputum and blood samples) - provided significant lung function benefit over placebo in asthma in two Phase II trials. Synairgen believes SNG001 could help prevent worsening or accelerate recovery of severe lower respiratory tract illness in COVID-19 patients. Patients who are in hospital or non-hospitalised but are a high risk groups (e.g. elderly or diabetics) will be invited to take part in the trial. The patient would receive either SNG001 or placebo once daily for 14 days. The severity of the patients condition would be recorded on a scale developed by the World Health Organisation and the patient would be asked questions about their breathlessness, cough and sputum every day, as well as assess their general medical condition and safety. The study will start as a Pilot phase where 100 patients will be randomised in the hospital setting and a 120 patients randomised in the home setting. Once each of the Pilot phases are complete, a Pivotal phase will be conducted. It is estimated that the size of each of the Pivotal phases (hospital and home) will be around 100 to 300 patients per arm. The actual number will be determined after the data review at the end of each of the Pilot phases. If SNG001 proves to be beneficial it would be a major breakthrough for the treatment of COVID-19.

NCT ID: NCT04383678 Completed - COVID-19 Clinical Trials

Outcome of COVID-19 Patients After Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome

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

This study aims to investigate outcomes and predictors of outcome after extracorporeal membrane oxygenation (ECMO) therapy for severe acute respiratory syndrome (ARDS) in COVID-19 patients.

NCT ID: NCT04383054 Completed - Physical Activity Clinical Trials

Do PA Interventions Increase Acute Medical Inpatients PA Levels

Start date: August 24, 2020
Phase: N/A
Study type: Interventional

Physical activity (PA) can help treat and prevent many physical and mental health conditions. However, many of the United Kingdom population do not meet the Department of Health's PA recommendations which is contributing to the high chronic disease burden in the UK population. Many patients who are admitted to acute medical wards have at least one co- morbidity. Inpatients on acute hospital wards do not routinely receive PA advice from healthcare staff. The investigators believe that patients could be encouraged to increase their PA level (PAL) during an admission to hospital.

NCT ID: NCT04382690 Completed - Hygiene Clinical Trials

Behavioral Determinants That May Influence People's Hand-hygiene and Environment Disinfecting

Start date: May 27, 2020
Phase:
Study type: Observational

An anonymous online survey will be conducted to measure the barriers and facilitators parents and teachers experience to positively influencing children's hand-hygiene. A sub-section of the survey will also examine the barriers and facilitators they experience to surface cleaning. The final survey will be conducted with participants from Australia, China, India, Indonesia, Saudi Arabia, South Africa, and the United Kingdom. The data collected will be completely anonymous and there are no sensitive questions. The primary and secondary analyses will focus on the hand-hygiene items to examine the survey's internal and external validity. The results will inform a future school-based intervention.

NCT ID: NCT04382664 Completed - Malignant Melanoma Clinical Trials

UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma

Start date: June 15, 2020
Phase: Phase 2
Study type: Interventional

UV1 is a therapeutic cancer vaccine that has been explored in prostate, lung cancer, in combination with ipilimumab in malignant melanoma and in combination with pembrolizumab in metastatic melanoma. This study will explore the Efficacy and Safety of UV1 administered with GM-CSF in combination with nivolumab and ipilimumab.

NCT ID: NCT04382001 Completed - Ovulation Clinical Trials

Heart Rate Variability During the Menstrual Cycle

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

In this study, women will be required to wear a chest heart rate monitor and wrist heart rate monitor daily and collect daily early morning urine samples for the duration of one complete menstrual cycle. This will enable comparisons between data collected from the heart rate monitor and hormone analysis in urine samples to be made.

NCT ID: NCT04381962 Completed - COVID-19 Clinical Trials

A Multicentre Open-label Two-arm Randomised Superiority Clinical Trial of Azithromycin Versus Usual Care In Ambulatory COVID19 (ATOMIC2)

ATOMIC2
Start date: June 3, 2020
Phase: Phase 3
Study type: Interventional

A multi-centre open-label two-arm randomised superiority clinical trial of two weeks of oral Azithromycin 500mg once daily versus usual care in adult patients presenting to secondary care with clinically-diagnosed COVID-19 but assessed as appropriate for initial ambulant (outpatient) management, in preventing progression to respiratory failure or death.

NCT ID: NCT04380896 Completed - Clinical trials for SARS-CoV-2 Infection

COVID-19 Staff Testing of Antibody Responses Study (Co-Stars)

Co-Stars
Start date: April 27, 2020
Phase:
Study type: Observational

This study will perform prospective repeated serological antibody testing on a cohort of at least 1000 healthcare workers at Great Ormond Street Hospital. Within this cohort, a subset of 150-250 staff members with confirmed (PCR positive) SARS-CoV-2 disease will be followed with intensive monthly testing for 6 months to determine whether antibody levels in the blood are maintained or decrease during this time. All 1000 recruited healthcare workers will be followed 6-monthly

NCT ID: NCT04380467 Completed - Clinical trials for Chronic Kidney Disease

Vitamin D Supplementation in CKD - Vascular Function, Structure and Immune Regulation

Start date: January 2016
Phase: N/A
Study type: Interventional

A pilot study to assess feasibility of methods of an observer-blinded randomised controlled trial of the effect of vitamin D supplementation in Chronic Kidney Disease and low vitamin D levels on markers of vascular function (Flow Mediated Dilatation of Brachial Artery), vascular structure (Carotid Intima Media Thickness) and Immune Regulation (frequencies of CD4+CD28null T lymphocytes ad Regulatory T lymphocytes).

NCT ID: NCT04379960 Completed - Clinical trials for The Initial Aim of This Project is to Perform in Vitro Validation of Neoepitope Candidates Selected From Available Mutanome Data

Identification of Immunogenic Neo-epitopes for the Development of Personalised Pancreatic Cancer Vaccines

CanVac
Start date: September 2016
Phase:
Study type: Observational

Human pancreatic cancer has a very poor prognosis with an overall survival rate of less than 5%. Current treatment regimens are ineffective and even if the patient responds to initial treatments, relapse is common due to the survival of small populations of resistant cancer cells. The immune system is capable of recognising and eliminating invading organisms by virtue of differences in their appearance when compared to normal components of the body. Cancer cells also have a different appearance compared to normal cells. However, these differences are often too small and weak to stimulate the immune system sufficiently to respond effectively to eliminate the tumour. Our aim is to analyse the small differences between healthy and cancer cells in pancreatic cancer patients. Analysis of the genetic information from 100 pancreatic cancer patients has allowed us to design molecules that display each of these small differences. We now intend to analyse each of these, with respect to their ability to stimulate an immune response against cancer. We then intend to take all validated molecules and incorporate them into vaccines carried by viral vectors. These vaccines can be used to train the patient's immune system to respond more effectively when it encounters these particular differences in the patient's body and thus mount an efficient attack on the cancer cells specifically. Surplus material from blood donations will be used to isolate individual components of the immune system, which can be examined for their response to these altered molecules in the laboratory. On completion of this project, we will have viral vaccine libraries that can be tested in future research projects. Ultimately, we hope to transfer this regime to the clinic by selecting an appropriate viral vaccine library to deliver as a personalised therapeutic that can eliminate cancer and prevent cancer recurrence within each patient.