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Covid19 clinical trials

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NCT ID: NCT05386407 Active, not recruiting - COVID-19 Clinical Trials

Telemedically Assisted Sampling of COVID-19 Patients - Is the Sampling Quality Sufficient

Start date: April 14, 2022
Phase: N/A
Study type: Interventional

The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) pandemic has resulted in more than 3.8 billion registered tests, 275 million positive cases, and 5 million deaths worldwide. Early and regular testing has been an important pillar of secondary prevention since the beginning. However, this pandemic has also fostered solutions in the form of e telemedicine with enormously increased applicability. The question of whether telemedically supervised testing with SARS-CoV-2 Rapid Antigen Tests is non-inferior to the same tests being carried out by trained personnel in test centers is still unanswered. With this study, the investigators aim to compare and evaluate the reliability and sampling quality of telemedically guided self-performed rapid tests for professional use compared to professional sampling by healthcare personnel. Our hypothesis is that, applying a strict standard operating procedure (SOP, attached), guided oropharyngeal + nasal (OP+N) self-sampling (GSS) is non-inferior to nasopharyngeal (NP) or OP+N sampling performed by health care professionals (HCP), and that guided OP+N sampling is superior to unsupervised OP+N self-sampling (USS).

NCT ID: NCT05384899 Active, not recruiting - Covid19 Clinical Trials

Kidney Precision Medicine Project (KPMP) - COVID-19 Protocol

Start date: June 15, 2021
Study type: Observational

Since its inception, KPMP has developed sophisticated protocols for collection and analysis of human kidney tissue, and for collection of biofluids. Members of the consortium have wide-ranging expertise in conducting clinical studies, processing kidney tissue, advanced structural and molecular analysis and complex bioinformatics analysis, which will be used to leverage effectively as a group to better understand kidney disease. This joint protocol aims to synergize the COVID-19 study efforts of KPMP academic research centers, to collectively study COVID-19, including its renal presentation using kidney tissue and/or biofluids from patients suffering from COVID-19. This will increase the breadth and depth of data available to the public to expedite discoveries, identify therapeutics, and improve outcomes for patients with COVID-19. It will additionally bring the expertise of KPMP investigators to bear against this pandemic.

NCT ID: NCT05384574 Active, not recruiting - Covid-19 Clinical Trials

Vitamin D Supplementation and Clinical Outcomes in Severe COVID-19 Patients

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

Single center, open label randomized clinical trial. Study location: tertiary hospital center (University Hospital Split, Croatia). All COVID-19 patients with positive PCR test admitted to ICU and in need for respiratory support will be eligible for inclusion in this study. Patients admitted to ICU with severe COVID-19 disease and in need for invasive or non-invasive respiratory support with low levels of vitamin D (<50 nmol/l) measured on admission. All patients are older than 18 years and have confirmed COVID-19 disease with PCR test. Intervention: All patients included in this study will receive standard of care. Patients randomized into intervention group will be receiving 10 000 IU of cholecalciferol daily. Supplement will be administered orally or via gastric tube during ICU stay or for at least 14 days in case of ICU discharge before day 14. Supplementation will begin within 48 hours of admission to ICU. Supplement will be prepared and administered by experienced nursing staff. For patients receiving supplementation, vitamin D levels will be checked on days 7 and 14. In case that vitamin D levels are > 150 nmol/l or if the calcium levels are consistently > 2.6 mmol/l, further supplementation will be stopped. Outcomes: Primary outcome is number of days spent on ventilator. Secondary outcomes: all-cause mortality on day 28, all-cause mortality on day 60, mortality at hospital discharge, clinical improvement at day 28 (WHO clinical progression scale), days spent in ICU, days spent in hospital after discharge from ICU, need for dialysis at day 28, bacterial superinfections, neutrophile to lymphocyte ratio, disease severity (CRP levels, PaO2/FiO2 ratio, D-dimer levels, fibrinogen, ferritin, PCT), adverse outcomes. Hypothesis: patients receiving Vitamin D supplementation will have shorter number of days spent on mechanical ventilation.

NCT ID: NCT05378191 Active, not recruiting - Covid19 Clinical Trials

Vaccination With COMIRNATY in Subjects With a VAXZEVRIA First Dose

Start date: April 22, 2021
Phase: Phase 2
Study type: Interventional

CombiVacS is a phase 2 randomized, adaptive trial developed to evaluate the immunogenicity of a dose of COMIRNATY after a previous single dose of VAXZEVRIA. A stratification will be made based on the following factors: study site, sex and age. This protocol allows to test the immunogenicity and safety of a heterologous vaccination strategy after a previous single dose of VAXZEVRIA.

NCT ID: NCT05371275 Active, not recruiting - COVID-19 Clinical Trials

Phase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent Thromboinflammation

Start date: April 21, 2022
Phase: Phase 2
Study type: Interventional

This is a one-site, interventional, prospective, single-arm, open-label, controlled phase-IIa trial evaluating the safety and efficacy of palbociclib in hospitalized, moderate COVID- 19 cases.

NCT ID: NCT05365750 Active, not recruiting - COVID-19 Testing Clinical Trials

COVID-19 Antibody and Reinfection Study

Start date: June 15, 2020
Study type: Observational [Patient Registry]

The goal of this study is to identify Kaiser Permanente Colorado (KPCO) members who have had COVID-19 infection for serial antibody testing and PCR testing to: 1. Quantify antibody titers among previously infected COVID-19 participants over 9 months. 2. Determine the rates of asymptomatic, mild, and severe recurrent infection among COVID-19 participants. 3. Examine association between antibody titer levels and risk of recurrent infection. We will also identify KPCO members from the overall membership did not have any evidence of COVID-19 infection as a comparison group. In these participants we will also conduct serial antibody and viral testing and measure infection rates. This will allow us to compare whether participants with and without antibodies have different rates of infection.

NCT ID: NCT05353738 Active, not recruiting - COVID-19 Clinical Trials

Efficacy of Vaccination Against COVID-19 in Patients Presenting a Neuromuscular Disease With Severe Amyotrophy

Start date: September 1, 2021
Study type: Observational

Des vaccins sont désormais disponibles en France, dont le vaccin Moderna COVID-19 qui est basé sur la technologie des ARNm. La séquence génétique qu'il contient code pour la protéine Spike (S) de l'enveloppe virale, protéine clé de la pénétration du virus dans les cellules qu'il infecte. Le vaccin ARNm est injecté par voie intramusculaire et pénètre dans les fibres musculaires, qui sont des cellules produisant des protéines en très grande quantité en continu, notamment pour la production de myofibrilles impliquées dans la contraction musculaire. Une fois à l'intérieur de la fibre musculaire, l'ARNm vaccinal est traduit par la machinerie de la fibre musculaire permettant une grande quantité de protéine Spike (S) qui sera présentée au système immunitaire provoquant la réponse vaccinale et notamment les anticorps neutralisants anti-S (NAb). Ces NAb anti-S agissent en perturbant l'interaction entre la protéine S du virus et le récepteur ACE2 (Angiotensin-Converting Enzyme 2), qui sert généralement de " passerelle " entre le virus et la cellule. Une campagne de vaccination est actuellement en cours au MAS-YDK avec le vaccin Moderna. Cette population est donc relativement homogène en termes d'amyotrophie, de non exposition au SARS-CoV-2 et de protocole vaccinal.

NCT ID: NCT05352867 Active, not recruiting - SARS-CoV-2 Clinical Trials

Clinical Trial of SARS-CoV-2 mRNA Vaccine in Chinese People

Start date: March 9, 2022
Phase: Phase 2
Study type: Interventional

Phase Ⅱ Clinical Trial to Evaluate the Safety and Immunogenicity of the New Coronavirus mRNA Vaccine (LVRNA009) in Chinese People Aged 18~59 Years

NCT ID: NCT05348720 Active, not recruiting - COVID-19 Clinical Trials

Impact of a COVID-19 Related ICU Stay on Mental Health for Patients and Their Relatives

Start date: March 1, 2020
Study type: Observational

As ICU mortality has been significantly decreased over the last two decades, the focus has been shifting from short term (such as ICU and hospital mortality) to long-term outcome. This evolution has led to a new entity that has been established in 2012 at a stakeholder conference: the Post-Intensive Care Syndrome (PICS). It is defined as impairments in physical, cognitive and mental health status arising after critical illness and persisting beyond acute care hospitalisation. As family members of ICU patients may also be affected by mental health impairment, the PICS-F (F for Family) has been introduced simultaneously. It is expected that the COVID-19 pandemic will result in a significant increase of the proportion of patients and relatives suffering PICS and PICS-F, as there is during the COVID-19 related ICU-stay exposure to a high number of risk factors for developing these entities. This Post Intensive Care Syndrome in COVID-19 survivors (PICOVIDS) study is an observational, single-center exploratory follow-up cohort study that aims to get insight into the mental impact of a COVID-19 related ICU stay for COVID-19 ICU survivors and their family members, 18 months after ICU discharge. Specific research questions are: 1. What is the prevalence of symptoms of depression, anxiety and Post Traumatic Stress Disorder (PTSD) and what is the prevalence of these specific disorders in COVID-19 ICU-survivors and their relatives 18 months after ICU-discharge? 2. What are important risk factors for these symptoms and disorders? 3. What is the satisfaction level of patient and caregiver about the ICU care: How did they experience ICU stay?

NCT ID: NCT05338177 Active, not recruiting - COVID-19 Clinical Trials

Pilot Trial on Immunosuppression Modulation to Increase SARS-CoV-2 Vaccine Response in Kidney Transplant Recipients

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

Mycophenolate has been identified as risk factor for non-response to SARS-CoV-2 vaccination in kidney transplant recipients. Safety and efficacy of temporarily stopping of mycophenolate (or azathioprine) to increase vaccine response has not been established. This is a non-randomized, controlled pilot study including up to 40 kidney transplant recipients not responding to at least three previous SARS-CoV-2 vaccine doses. Mycophenolate or azathioprine will be stopped for two weeks peri-vaccination starting one week before vaccination until one week after vaccination. Allocation to mycophenoalte or azathioprine discontinuation arm will be based on an overall risk assessment by the transplant physician and patient preference. Patients not stopping mycophenolate or azathioprine will serve as control group.