View clinical trials related to Covid19.
Filter by:An open label, randomized, dose comparison, sequential cohorts study design in healthy volunteers (young adults) is a frequently used design in vaccine Phase 1 studies. ACM-001 is developed as a booster vaccine against SARS-CoV-2 after a full primary vaccination with or without 1-2 booster doses (2 or 3 or 4 doses) schedule with any registered and commercial SARS-CoV-2 vaccines. The plan is to start with a low dosage of antigen alone, followed by a combination of antigen and adjuvant and then to progress to higher dosages to define the safety profile of the candidate vaccine as primary endpoint, and its immunogenicity as secondary endpoint.
The thyroid gland has been shown to be a common target for COVID 19 virus. Babies born to mothers positive for COVID 19 infections were noticed to have elevated thyroid stimulating hormone ( TSH ) levels on screening. Thyroid function tests were monitored in these babies to determine presence of temporary or permanent thyroid disorders following COVID 19 infections during pregnancy.
The objectives of this project are to (1) assemble a crowdsourced, de-identified radiographic repository; and (2) train and validate existing COVID-NET deep learning diagnostic models.
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.
Novel coronavirus disease (COVID-19), caused by Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus, was first reported in December 2019 in Wuhan, China. The disease has spread to many countries in a few weeks and has become a global public health problem. By 2022, the virus has infected more than 500 million people worldwide and caused more than 6 million deaths. Case fatality rates (CFR) are an important index that helps to understand the epidemiological characteristics of an epidemic. In the data coming in 2020, COVID-19 CFR values were generally reported in the range of 0.001-0.706. However, from 2019 to 2022, there were 2 major changes that could affect the CFR of the disease. The first of these is vaccine applications, and the second is the new variants of SARS-CoV-2, which appeared first. From 2019 to 2022, it is likely that there will be a change in the mortality of COVID-19 in relation to both the vaccines administered and the new variants emerging. However, the data on this subject are not clear yet and more studies are needed. The aim of this study is to determine whether there is a change in the mortality of COVID-19 from 2019, when it first appeared, to 2022.
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.
Olfactory dysfunction is a defining symptom of COVID-19 infection. Studies have demonstrated improved olfaction in patients with post infectious olfactory dysfunction after an olfactory training (OT). The aim of this study is to assess the clinical outcomes of olfactory training (12 weeks) therapy in the treatment of persistent olfactory dysfunctions after COVID-19. Specially, we aim to compare the effectiveness of two different olfactory training (different odors) with a placebo group. A group will train themselves with 4 scents (rose, orange, clove and eucalyptus) and another group with 4 different scents (cheese, coffee, strawberries and lemon). The placebo group will train themselves with an odorless substance. Olfaction sensory evaluation will be performed by using different olfaction tests (Sniffin' Sticks and UPSIT) and complete questionnaires to assess olfactory perception and particularly parosmia and phantosmia.
Patients with cancer are considered vulnerable to SARS-CoV-2 infection and have been prioritized in the vaccination process in several countries, including Taiwan. In addition, international oncological societies favored COVID-19 vaccination for cancer patients on the basis of risk and benefits evaluation of all available data. However, patients with cancer were excluded from SARS- CoV-2 vaccines registrational trials and the investigators lack data regarding the safety and efficacy of vaccination in this population. Under this perspective, the investigators undertook a large prospective study enrolling patients with solid cancers, hematologic malignancies as well as healthy volunteers for the kinetics of anti- SARS-CoV-2 antibodies after COVID-19 vaccination on different anticancer therapy. Major inclusion criteria for this cohort of the study included: (1) age above 20 years; (2) presence of solid organ malignancies treated with immunotherapy, chemotherapy, Targeted therapy irrespective of the treatment phase; and (3) eligibility for vaccination.
A retrospective study to evaluate the predictability of abnormal arterial blood gas measurements through novel observations of continuous trends in electronically measured respiratory in a mixed cohort of respiratory compromised patients.
Under protocol versions 1.01-1.06: The five recently emerged SARS-CoV2 variants that were designated as VOCs are the Alpha variant, Beta variant, Gamma variant, Delta variant and the Omicron variant. The current dominant Omicron variant was designated a VOC by WHO on Nov 26, 2021, and was found to comprise 85% of reported variants in late January 2022. Studies have shown that the prevalent Omicron mutations in the S1 subunit RBD region and NTD region could dramatically change the antigenic features of the viral spike, leading to significantly reduced neutralization Omicron harbors 30 signature mutations (>50% prevalence) of which 15 are in the S1 subunit RBD region and 8 are in the S1 subunit NTD region. Omicron is a highly contagious variant with threatening immune evasion capabilities even despite robust immune response. Initial modeling showed the Omicron variant being 2.8 times more infectious than the Delta variant. While current vaccines are losing protection against Omicron with respect to infection and mild disease, there is still considerable protection from hospitalisation and severe COVID-19, especially after a booster dose. The International Coalition of Medicines Regulatory Authorities (ICMRA) COVID-19 Omicron Variant Workshop encouraged the international scientific community and vaccine developers to look at alternative approaches to monovalent vaccines. In ICMRA's view, companies should also explore the feasibility of developing bivalent or multivalent variant vaccines to determine if they offer advantages to monovalent vaccines. As advised by ICMRA, the investigated vaccine, mRNA-1273.214 is a bivalent vaccine containing the ancestral SARS-CoV-2 and the Omicron variant spike sequences that will be evaluated as a heterologous boost. Under protocol version 1.07:The study will also investigate the safety, reactogenicity and immune response of the mRNA-1273.222 administered as a boost vaccine after primary series vaccination comprising 3 doses of an mRNA vaccine . This study hypothesizes that the peak level of antibodies against SARS CoV-2, will be at two weeks after the first study dose is administered, which is similar to other recent findings (Anderson et al., 2022).2.2.1. The bivalent mRNA-1273.222 vaccine contains mRNA encoding for the spike protein of BA.4/BA.5 as well as mRNA encoding for the original (ancestral Wuhan-Hu-1) strain of the SARS-CoV-2 virus.