View clinical trials related to Covid19.
Filter by:The purpose of the pilot study is to examine acceptability and proof of concept effectiveness of a wireless TENS technology to address PACS associated FM. Sample size (n=40) is convenient and designed to explore acceptability and feasibility. Eligible participants will be screened at the BCM Post-COVID-19 Clinic for inclusion criteria. Participants, who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with ratio of 1:1 into two groups. One group will utilize TENS functional devices (Active group, AG); the other group will utilize TENS non-functional devices (Placebo group, PG). The baseline measurements will be performed, and the patients will take the programmed device home for a duration of 4 weeks. Then, the patients will come back after four weeks (4W). At this 4th week visit, both groups will be unblinded and the AG will keep their functional device and the PG group will receive a functional device. Both groups will continue to deliver 3-5 hour of stimulation daily, until their final 8th week follow up visit (8W). The primary outcomes will be pain symptoms, sleep and fatigue. Secondary outcomes include limb strength and perfusion, gait assessment (gait speed, stride length, double stance, and gait steadiness), balance, pulse oximetry, and quality of life. The coordinator will utilize a weekly spreadsheet showing utilization (therapy sessions/day, logged in the Quell health Cloud) so compliance can be monitored and those that are not using the device can be encouraged.
Severe and sometimes irreversible sequelae are observed in people who have developed a severe form of COVID-19 (pulmonary, cardiovascular, renal, neurological sequelae among others). More than 10% of individuals who contracted the disease, even in a mild form, still have at least one of the initial symptoms at six months, also known as prolonged symptoms or long COVID syndrome. The most frequently observed symptoms are asthenia, neurological disorders (headache, anosmia, ageusia, etc.), cardio-thoracic disorders, pain, digestive or skin disorders. Very recently, the first results of a British prospective cohort study (PHOSPCovid) indicate that more than half of the COVID-19 survivors who were hospitalised experienced a very severe to moderate deterioration in their mental and/or physical health five months after hospitalisation. Women are particularly affected. Another American study shows that 85% of non-hospitalised COVID-19 patients developed at least 4 neurological symptoms impacting their quality of life. The most common are: "brain fog" (81%), headaches (68%), numbness or tingling (60%), taste impairment (59%) and loss of smell (55%). These disabling symptoms may persist for weeks or months, deteriorating the quality of life of patients and making it difficult for some to return to a normal life. On the basis of current knowledge concerning the long-term sequelae of SARS-CoV-2 infection, it seems necessary to offer these subjects a specific care pathway and to adapt their living and working conditions beyond their medical care. The present study is aimed at measuring the impact of long COVID on the health and quality of life of the defence community (military personnel and their families).
The study RECOVER is a randomized, open-label, multicenter phase II trial, designed to assess the clinical outcome of SARS-CoV-2 disease in high-risk patients (group 1 to group 4) following treatment with anti-SARS-CoV-2 convalescent/vaccine-boosted plasma or standard of care.
To evaluate the safety and immunogenicity of DelNS1-2019-nCoV-RBD-OPT1 as booster vaccine for COVID-19 in healthy adults who have received 2 doses of BNT162b2
The novel coronavirus (SARS-CoV-2) infection (COVID-19) has caused a worldwide pandemic. There is still much that is unknown regarding the virus, especially its effects on pregnancy, the fetus, and the neonate. This study seeks to evaluate adverse pregnancy and neonatal outcomes related to COVID-19 infection. The FDA has authorized emergency use authorization for the SARS-CoV-2 messenger ribonucleic acid (mRNA) vaccines from Pfizer and Moderna. Pregnant women were excluded from the Phase III clinical trials of the mRNA vaccines. There are no studies that have evaluated functional antibody responses, antibody reactivity to variant viruses, T cell frequencies or activity, or protection against infection or development of COVID-19. Having a more detailed understanding of how pregnancy and lactation alters the longevity, specificity, and activity of antiviral antibody and T cell-mediated immune responses to COVID-19 mRNA vaccines is essential for the FDA to inform future recommendations and regulation of these vaccines.
This randomized control trial aims to explore a data-driven, proactive approach to identifying patients at greatest risk during the pandemic, and assess the impact of an embedded System Navigator in a primary health care setting. The System Navigator works one-on-one with patients to identify and provide support to their biological, psychological and social needs (e.g. income, housing, food security). Investigators are doing this study to find out whether proactive identification of vulnerable patients and linking to a System Navigator leads to reduction in emotional distress associated with managing complex health conditions and unmet social needs during COVID-19, compared to usual care. Investigators will involve approximately 180 patients from primary care clinics that are a part of the University of Toronto Practice-Based Research Network (UTOPIAN). The information from this study will be used to help us understand how proactive engagement within a primary health setting can help to improve the health of patients during COVID-19, and beyond.
The COVID-19 crisis has rapidly become the most significant public health crisis of our times. It has particularly impacted healthcare workers (HCW) due to the over-whelming of healthcare resources, as well as a critical absence of protective equipment and risk to their own health as well as the risk of exposure to their family. All these factors have likely resulted in significant levels of stress, anxiety, and affection of the general health
The COVID-19 infection affects humans differently. While some recover quickly and fully, others develop serious illnesses and late complications. The term late complications describe symptoms that last for 12 weeks or longer after COVID-19 infection is detected. The aim of the present project is to investigate whether it is possible to identify genetic factors that occur more frequently in people suffering from COVID-19 late complications than in those who do not develop late complications. The investigators aim to develop a genetic profile that identifies individuals at high risk for late complications of COVID-19. Number and nature of late complications will be analyses to identify patterns in the incidence of late complications associated with certain genetic traits. The study is designed as a case-control study and is expected to include 500 subjects between 18 and 65 years of age who at least 12 weeks ago tested positive for COVID-19; 250 who suffer from late complications and 250 who have fully recovered.
The study will be a prospective cohort design to determine if children generate aerosols that harbor a viral load similar to adults. Prior to beginning enrollment, researchers may recruit up to 10 participants (adults or children who meet inclusion criteria for the main study) to perform a small pilot to optimize our cold chain and laboratory procedures. The study will include children and adults who are confirmed SARS-CoV-2 positive and aim for a total sample size of at least 10 children and 10 adults. Hypothesis: As children have a high viral load in the nasopharynx, we hypothesize that children generate aerosols that contain SARS-CoV-2 virus. Aim: To estimate the viral load in aerosols generated from children with COVID-19 infection, and to compare the viral load contained in aerosols from children with aerosols from adults
Novel antiviral drugs can mark a turning point in the prevention and treatment of patients with Covid-19. Recently, several independent large phase-III RCTs have shown that the intravenous administration of one gift of neutralizing SARS-CoV-2 monoclonal antibodies can reduce the relative risk of hospital admission and/or death with 70-85% in seronegative patients with SARS-CoV-2 infection when given within 3 to 7 days after state of symptoms. Moreover, novel oral anti-viral compunds such as molnupiravir and nirmatrelvir/ritonavir could reduce the risk of hospitalisation or death by 30% to89% in at-risk adults with Covid-19. These are potential breakthroughs in the treatment of SARS-CoV-2 infection and can be of special importantance for immunocompromised patients who have a diminished or complete lack of an effective humoral response towards Covid-19 vaccination. Monoclonal SARS-CoV-2 antibodies and antivirals have been given an emergency use authorization by regulatory authorities and are or will become available in the Netherlands to treat SARS-CoV-2 infected patients who are at high risk of developing severe disease. Now, urgent key questions need to be addressed: Which patient categories will benefit most from these new drugs? What are the SARS-CoV-2 viral load as well as inflammatory response kinetics during and after treatment with the new SARS-CoV-2 therapies? What is the safety profile in () patients; do new SARS-CoV-2 variants occur during treatment? This study aims to establish a prospective cohort together with a biobank of patients treated with new SARS-CoV-2 therapies to evaluate its real world effect and safety. Primary Objectives: - A. What are the SARS-CoV-2 viral load kinetics during and after treatment withneutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2? - B. Do viralvariants, spike mutations and immune escape occur during treatment with neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2?new SARS-CoV-2 therapies? - C. What are the viral antibody and inflammatory response kinetics during and after treatment with neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2? - D. To create a biobank to address future questions regarding the current use of neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2compared to novel COVID-19 treatments which are in development. Study design: Establishment of an observational cohort study including a biobank of patients who receive neutralizing monoclonal antibodies and other novel antiviral agents against SARS-CoV-2. Study population: All patients above 18 years of age treated with neutralizing monoclonal antibodies and other novel antiviral agents against SARS-CoV-2. Intervention (if applicable): None Main study parameters/endpoints: Viral load kinetics during treatment. Viral mutations during and after treatment. Presence of monoclonal antibody during treatment and host antibody production and inflammatory responses during treatment. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participating in this observational study will not directly benefit the participants and healthy volunteers. The study will provide information about the effect, host response and safety of thse new anti-SARS-CoV-2 therapies during Covid-19. Clinical data will be obtained through the electronic patient dossier. The knowledge obtained can potentially benefit Covid-19 patients in the future by optimizing treatment strategies. The burden and risks for patients participating in the TURN-COVID biobank study is minimal. Patients will be visited by a research physician or research nurse during or within three days after receiving neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2. Baseline data regarding medical history, admission and vital parameters will be collected through the electronic patient dossier. At the follow-up visits we will draw a total of (3x 43 ML and 1x16 ml = 145 ml of venous blood) and obtain 4 oro-/nasopharyngeal swabs divided over four time-points (day of treatment and day 7, 28 and 90 post treatment).