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NCT ID: NCT04480333 Recruiting - Covid19 Clinical Trials

Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and NA-831

NEUROSIVIR
Start date: September 15, 2020
Phase: Phase 1
Study type: Interventional

The clinical study is designed to evaluate the safety, tolerability and pharmacokinetics of inhaled nanoparticle nanoparticle formulation of Remdesivir (GS-5734) alone and in combination with NA-831 in 48 healthy volunteers.

NCT ID: NCT04479982 Recruiting - Covid19 Clinical Trials

Microbial Infection and AMR in Hospitalized Patients With Covid 19

Start date: September 24, 2020
Phase:
Study type: Observational

To detect microbial infection and AMR associated with COVID 19 infection. To correlate risk factors of COVID 19 patients with microbial infections and their effects on disease.

NCT ID: NCT04476680 Recruiting - Covid19 Clinical Trials

Influence of Military Preventive Policy for reCruit Training on COVID-19 Seroconversion

IMPACTCOVID
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

This study is intended to address the association between vitamin D status and seroconversion to SARS-CoV-2 in healthy young adults. The primary aim of the study is to determine the rates of 'silent' seroconversion rates, consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population with a wide spread of vitamin D concentrations. The secondary aims of this study are to explore: 1. Any effect of vitamin D status on symptomatic illness. 2. The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults. 3. The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time. 4. Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/ complementary serological method 5. The effect (if any) of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs and iii) gender.

NCT ID: NCT04470583 Recruiting - COVID-19 Clinical Trials

Evaluating Clinical Parameters of COVID-19 in Pregnancy

COpregVID
Start date: October 9, 2020
Phase:
Study type: Observational

Coronavirus infection, also known as COVID-19, has become a global pandemic with over 3 million cases and 250,000 deaths worldwide. Coronaviruses (CoV) belong to a family of viruses that predominately infect mammals and birds, affecting their lungs, intestinal tract, liver and nervous systems. Prior to the discovery of the current novel coronavirus strain (SARS-CoV-2), there were six different strains that are known to infect humans, which includes the virus that caused the severe acute respiratory syndrome (SARS) pandemic in 2002. In humans, the majority of severe illness from SARs and COVID-19 is due to inflammation of the lungs and pneumonia. Pregnancy poses a significantly increased risk of viral pneumonia and during SARS more pregnant women required intensive care and breathing support, and the proportion of deaths was higher when compared to non-pregnant adults. Furthermore, kidney failure and development of abnormal blood clotting disorders, which occurs during severe infection, is more common in pregnancy and the associated changes in blood vessels extend to the placentas of infected pregnant women, thus potentially affecting the fetus. This makes pregnant women affected by the virus at high risk of developing severe complications. Fortunately, there have been a number of biomarkers identified that are associated with illness severity. These include, specialised white blood cells, blood clotting cells and constituents, as well as other measures of heart and kidney function. We propose that these biomarkers are important correlates of clinical disease severity and prognosis in pregnant and postnatal women. This knowledge has the potential to help clinicians during this pandemic to better manage and care for their patients.

NCT ID: NCT04470518 Recruiting - Infection Clinical Trials

Impact of Clinical Guidance & Point-of-care CRP in Children: the ARON Project

ARON
Start date: January 6, 2021
Phase: N/A
Study type: Interventional

Impact of clinical guidance & point-of-care CRP test in children: the ARON project Trial Design: multicentre, cluster-randomized, parallel group pragmatic trial Trial Participants and setting: Children aged 6 months to 12 years of age with an acute illness episode presenting to in-hours general practice or out-of-hospital community paediatrics offices Intervention(s) Diagnostic algorithm: 1. Clinical decision tree: clinician's gut feeling something is wrong, dyspnea, temperature ≥40ºC 2. YES to any : point-of-care CRP ≥5mg/L: additional testing or refer to secondary care <5mg/L: safety netting*, only prescribe antibiotics if advised (guidelines) 3. NO to all : are AB considered? YES : point-of-care CRP ≥5mg/L: safety netting*, only prescribe antibiotics if advised (guidelines) <5mg/L: safety netting*, do not prescribe antibiotics NO: safety netting *safety netting advice: - inform parents on what to expect and what to look out for - interactive parent information booklet based on previous research Control: Diagnosis and Treatment/Management as per usual care: - guidance on AB prescribing: o Belgische Commissie voor de Coördinatie van het Antibioticabeleid (BAPCOC) guide (updated November 2019) o RIZIV consensus meeting report "Antibiotics in children in ambulatory care" Primary Endpoint: Antibiotic prescribing rate at index consultation Secondary Endpoint(s) - time until full clinical recovery (during follow up (day 1 to day 30)) - additional investigations (at index consultation and/or during follow up (day 1 to day 30)) - re-consultation (during follow up (day 1 to day 30)) - antibiotic prescribing rate (during follow up (day 1 to day 30)) Exploratory endpoints at the index consultation: - additional investigations (X-Ray, blood tests, urine tests, etc.) During a follow-up period (day 1 to day 30): - referral to hospital - additional investigations (X-Ray, blood tests, urine tests, etc.) - patients with full clinical recovery at day 7 and day 30 - admission to hospital - mortality - cost-effectiveness - patient satisfaction - qualitative study: endpoints Planned Sample Size: 7000 Timing of the intervention: Intervention at index consultation (at presentation to primary care) Follow-up duration: 30 days follow-up Duration of the trial (FPI-CSR): 43 months

NCT ID: NCT04463264 Recruiting - COVID-19 Clinical Trials

Efficacy and Safety Study of Nitazoxanide (NTX) in the Treatment of Patients With SARS-CoV-2 Virus Infection (COVID-19)

Start date: June 26, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Evaluation of the efficacy and safety of NTX in adult patients (≥18 years and <60 years), with SARS-CoV-2 infection with mild symptoms of COVID-19, compared to a placebo control arm. 135 patients will be randomized to either Nitazoxanide (n=90) or placebo (n=45) (2:1). Simple blind design. Primary endpoint: eradication of virus from patients' respiratory tract secretions by the 7th day of treatment.

NCT ID: NCT04461340 Recruiting - COVID 19 Clinical Trials

Efficacy and Safety of Sirolimus in COVID-19 Infection

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

This research is planned to illustrate the efficacy and safety of sirolimus as an adjuvant agent to the standard treatment protocol against COVID-19 infection

NCT ID: NCT04459351 Recruiting - COVID-19 Clinical Trials

PHenotyping patiENts Admitted to Hospital With cOvid-19 Infection and idenTifYing Prognostic markErs

PHENOTYPE
Start date: June 19, 2020
Phase:
Study type: Observational

PHENOTYPE is an investigator-led, observational cohort study which aims to explore the long-term outcomes of patients with COVID-19 infection and to identify potential risk factors and biomarkers that can prognosticate disease severity and trajectory.

NCT ID: NCT04456075 Recruiting - COVID Clinical Trials

Risk Prediction and Therapy Monitoring in Patients With SARS-Cov-2 Infection / COVID 19

CROWNLESS
Start date: April 1, 2020
Phase:
Study type: Observational

Approximately 15% of patients with SARS-CoV-2 infection / COVID-19 develop a severe clinical course. This leads to hospitalization and potentially life threatening complications such as pneumonia and respiratory failure. Predictors for early detection and risk stratification are urgently needed. Moreover, only scarce information is available for long-term follow-up and late complications associated with infection. We therefore aimed to find predictors for severe courses of the novel disease as well as to establish strategies for therapeutic monitoring and follow-up.

NCT ID: NCT04452773 Recruiting - COVID19 Clinical Trials

Clinical Trial to Evaluate the Efficacy of Food Supplement Manremyc® Against SARS- COV-2 Infection (COVID-19) in Healthcare Workers

Start date: July 14, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the efficacy of Manremyc® food supplement for reduce the incidence of SARS-CoV-2 infection in a high risk population, as healthcare workers.