Evaluation of an Integrative Medicine Outpatient Clinical Setting for Post-COVID-19 Patients
COVID-19FatigueThe study aims to identify whether a multimodal integrative naturopathy outpatient clinical concept can improve the symptoms of patients suffering from post-COVID-Syndrome. Main outcome is fatigue. The outpatient clinical programme consists of 11 weeks wherein patients visit the clinic one day per week. The pillars of classical naturopathy are combined with extended naturopathy and complementary procedures. Previous naturopathical studies on patients with chronic fatigue syndrome could find numerous indications that different types of naturopathy can help patients with fatigue.
Combination of Inhaled DNase, Baricitinib and Tocilizumab in Severe COVID-19
COVID-19 Severe Respiratory FailureIn patients with COVID-19, severe hypoxemic respiratory failure (SRF) leading to invasive mechanical ventilation (IMV), raises the mortality rate substantially. Thus, the management of patients with SRF to avoid intubation and intensive care admission is a challenging and crucial issue. This study describes, as rescue/compassionate treatment, a therapeutic protocol based on the multi-mechanistic nature of severe COVID-19, using the combination of inhaled DNase, Baricitinib and Tocilizumab on top of standard of care (SOC) consisting of heparin and dexamethasone. COVID-19 patients with SRF who were treated with SOC, SOC plus Anakinra (ANA), and SOC plus Tocilizumab (TOCI) will be studied as comparators. Primary endpoint will be the reduction of the in-hospital mortality rate, whereas secondary endpoints concern intubation rate, days of hospitalization and overall survival as derived from the last follow-up visit, either in-office or remote. This is a non-randomized, open-label, study, conducted in the First Department of Internal Medicine, University Hospital of Alexandroupolis, Greece.
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19):...
Lower Respiratory Tract InfectionParainfluenza2 moreThis study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19.
The MentalPlus® for Assessment and Rehabilitation of Cognitive Function After Remission of the Symptoms...
Cognitive ImpairmentCovid194 moreThis study evaluates and rehabilitates the cognitive functions of attention, memory, visual perception, language, and executive by the mentalPlus® digital game of COVID-19 surviving patients after remission of symptoms.
Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized...
Covid19No therapeutic agent is currently approved for the treatment of SARSCoV-2 infection. More importantly, no intervention is currently available to mitigate the progression of disease from mid/moderate to serve particularly in high risk patients. Recognizing this limitation and urgency of finding a treatment for COVID-19, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergencyuse of the unapproved product bamlanivimab or casirivimab + imdevimab for the treatment of mild to moderate coronavirus disease 2019 (COVID19) in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Nebulised Heparin in Patients With Severe COVID-19
Covid19Respiratory FailureThe Can nebulised HepArin Reduce morTality and time to Extubation in Patients with COVID-19 Requiring mechanical ventilation Meta-Trial (CHARTER-MT) is a prospective collaborative individual patient data analysis of randomised controlled trials and early phase studies. Individual studies are being conducted in multiple countries, including Australia, Ireland, the USA, and the UK. Mechanically ventilated patients with confirmed or strongly suspected SARS-CoV-2 infection, hypoxaemia and an acute pulmonary opacity in at least one lung quadrant on chest X-ray, will be randomised to nebulised heparin 25,000 Units every 6 hours or standard care (open label studies) or placebo (blinded placebo controlled studies) for up to 10 days while mechanically ventilated. All trials will collect a minimum core dataset. The primary outcome for the meta-trial is ventilator-free days during the first 28 days, defined as being alive and free from mechanical ventilation. Individual studies may have additional outcomes.
Inhaled Heparin for Hospitalised COVID-19 Patients
Covid19This meta-trial is a prospective collaborative individual participant data meta-analysis of randomised controlled trials and early phase studies. Individual studies will be conducted in multiple countries, including Australia, the UK, the USA, Ireland, Argentina, Brazil and Egypt. Adult patients admitted to the hospital with confirmed SARS-CoV-2 infection, who do not require immediate mechanical ventilation, will be randomised to inhaled nebulised heparin or standard care for up to 21 days or until the patient has no respiratory symptoms. All studies will collect a minimum core dataset. The primary outcome for the meta-trial is the proportion of patients who receive invasive mechanical ventilation censored at day 28. Individual studies may have specific outcome measures in addition to the core set.
Convalescent Plasma Collection and Treatment in Pediatrics and Adults
COVID19Coronavirus Infection3 moreThis 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.
Association Between Smell Training and Quality of Life in Patients With Impaired Sense of Smell...
COVID-19Aim: The aim is to investigate whether guided systematic olfactory training with essential oils to improve impaired sense of smell following COVID-19, can improve patients' quality of life. Hypothesis: The impaired quality of life in patients with impaired sense of smell following COVID-19, can be significantly improved in patients performing olfactory training with essential oils, compared to patients performing olfactory training with placebo oils. Study design: The study is a randomized clinical trial with an intervention group and a control group. The intervention group receive four essential oils with scents of orange, lavender, clove, and peppermint. Patients in the control group receive a fragrance kit, consisting of the same containers, but with fragrance-free oils added. Both groups are instructed to smell each of the four oils for 30 seconds in the morning and evening, over a three-month intervention period. Patients are given a diary in which to record their olfactory training. The nurse or medical student instructing the patients in the training and performing the smell and taste tests is blinded. Study population: Patients referred to the Unit for Sense of Taste and Smell in the Department of Otorhinolaryngology Head & Neck and Audiology at Rigshospitalet. Inclusion criteria: Impaired sense of taste and smell following COVID-19 > 3 months Hyposmia (15-30) or anosmia (<15) assessed by Sniffin' Sticks Olfactory Test for Threshold, Discrimination and Identification (TDI) performed in the Unit for Sense of Taste and Smell or medical assessment of parosmia based on medical history > 18 years of age Exclusion criteria: Cause of hyposmia, anosmia or parosmia other than COVID-19 Impaired sense of taste and smell >24 months Does not read or speak Danish Lack of compliance to perform daily olfactory training Procedures: TDI-test: To assess patients' sense of smell, the TDI-test with Sniffin' Sticks is used, which is a validated tool with normative data. Taste test: To assess patients' sense of taste, taste sprays with the basic tastes are used. Questionnaires: 'Taste and Smell Tool for Evaluation' is used to investigate quality of life related to impaired sense of taste and smell. 'Major Depression Inventory' (MDI) is used in the project to assess whether the patient is depressed and to make a possible assessment of the severity of depression.
Bank of Human Leukocytes From COVID-19 Convalescent Donors With an Anti-SARS-CoV-2 Cellular Immunity...
COVID-19The SARS-CoV-2 identified in China in January 2020 is the cause of an unprecedented pandemic. The SARS-CoV-2 and each viral variant are responsible of a respiratory infectious disease, which can be asymptomatic. Nevertheless, a part of infected patients will experiment serious forms associated with a high mortality rate. Most serious forms present with lymphopenia and a functional exhaustion of speicifci T lymphocytes. Several studies showed that these quantitative and qualitative lymphocyte abnormalities are associated with unfavourable patients' outcome. The investigators hypothesized that the use of anti-viral T lymphocytes from convalescent COVID 19 donors could be helpful to improve the prognosis of COVID-19 serious forms. This study aims to demonstrate the feasibility of setting up a biobank that could allow the preservation and production of a cellular immunotherapy specific to SARS-CoV-2.