View clinical trials related to Covid19.
Filter by:The purpose of the study is to compare the efficacy of anti-COVID-19 immune globulin (human) 20% (C19-IG 20%) (2 doses) versus placebo with regard to the percentage of asymptomatic participants who remain asymptomatic, i.e., who do not develop symptomatic coronavirus disease 2019 (COVID-19) through Day 14 as per the protocol defined criteria.
Approximately 28,000 subjects will be enrolled in this trial. Eligible subjects will be stratified by age (<60 years of age and ≥60 years of age, the proportion of elderly people ≥60 years old is planned to be ≥25%) and randomly assigned into the study group and the control group at a ratio of 1:1 (14,000 in each group) to be intramuscularly administered with the investigational vaccine or placebo in a 2-dose regimen at an interval of 28 days. The experimental vaccines will be cross-vaccinated after available data of the investigational vaccine show that expected efficacy and good safety have been achieved (i.e., subjects in the study group will be vaccinated with placebo and those in the control group will be vaccinated with the investigational vaccine in the same schedule as stated above ). After the completion of the second dose for crossover vaccination, subjects will be followed up for 12 months for safety observation. An immunogenicity subgroup (n≥3000) and a reactogenicity subgroup (n≥6000) will also be included in this trial to evaluate the humoral immunity induced by the investigational vaccine and the solicited adverse events observed within 7 days post immunization. All enrolled subjects will be followed up for the evaluation of protective efficacy as well, which will be primarily characterized by the incidence rate (person-year) of COVID-19 cases collected from 14 days after complete series. Adverse events will be collected over 0-28 days after each vaccination and serious adverse events will be collected from Dose 1 through 12 months post complete series.
Health professionals are extremely exposed to psychosocial risks, as they experience, in general, high levels of stress, anxiety, fatigue and suffering, due to the nature and location of their work. As a result, the health and well being of these professionals can be significantly compromised. In outbreaks of serious infectious diseases and pandemics, these risks become amplified and the health team is at greater risk of falling ill, presenting changes in mental health and psychological trauma, while caring for infected patients and becoming potential contaminants in their family and community. The objective is to study the mental health of professionals who work in Pediatric Intensive Care Units (PICUs) in Brazil, during and after the COVID-19 pandemic. The primary outcome will be the prevalence of burnout in the team involved with the care of critically ill children. Secondary outcomes such as anxiety, depression, quality of professional life, compassionate fatigue and post-traumatic stress disorder will be measured. Possible associations between demographic, work and coping variables (social support and resilience) with mental and emotional health outcomes will be investigated, in an exploratory character. It is a multicenter, observational, longitudinal study, with a descriptive and exploratory analytical component. Data collection will be carried out through an electronic survey during and after the COVID-19 pandemic.
The PACAAP study aims to report the seroprevalence of SARS-CoV-2 IgG antibodies among HCWs testing during the massive campaign screening set up in France by French ministry of Health and national authorities in four hospital of the Alpine region.
As of August 16, 2020, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been responsible for more than 21 294 000 infections and about 760 000 deaths worldwide. Accumulating evidence suggests that patients with severe acute COVID-19 pneumonia have a cytokine storm syndrome, or unbalanced hyper-inflammatory response. It is now well known that GcMAF plays a crucial role in immune system regulation as a primary defense against infections. Thus, this multifunctional protein, released into the blood stream, acts as a systemic immune modulator without pro-inflammatory activities. In an animal study, IL-6 level was shown to be dramatically decreased after 21 days of oral administration colostrum MAF. Indeed, data from previous studies and clinical practice have been reported its effectiveness and safety in the treatment of many pathologies such as infectious diseases, some types of cancer, juvenile osteopetrosis, immunological, and neurological diseases. These observations suggest that oral immunotherapy with colostrum-MAF is potentially an effective and well-tolerated treatment for COVID-19 pneumonia. In addition, gastrointestinal involvement is well known in coronavirus infections of animals and humans. The angiotensin-converting enzyme II (ACE2), the entry receptor for SARS-CoV, is highly expressed in proximal and distal enterocytes that are directly exposed to foreign pathogens. It considers the mechanism of SARS-CoV-2 can actively infect and replicate in the gastrointestinal tract. SARS-CoV-2 indirectly damages the digestive system through a chain of inflammatory responses. Delivered topically to the small intestine by an acid-resistant enteric-coated capsule colostrum MAF can directly activate a large number of gut mucosal macrophages for virus control, localizing intestinal inflammation and resolving through driven phagocytic scavenger function. Macrophages in the gastrointestinal mucosa represent the largest pool of tissue macrophages in the body, which besides the local functions are directing the systemic immune response.
This is a phase 1/2 study in adult healthy subjects that have previously been vaccinated with an FDA-authorized vaccine against COVID-19. This clinical trial is designed to assess the safety, efficacy, reactogenicity, and immunogenicity of hAd5-S-Fusion+N-ETSD formulated for subcutaneous and oral (capsule) administration.
This is a prospective cohort study, observational, multicentre, single-arm, post-registration to assess the safety of the Adsorbed COVID-19 (Inactivated) Vaccine Sinovac / Institute Butantan.
Coronavirus disease 2019 (COVID-19) is a problem that is being faced in more than 200 countries in the world, including Indonesia. The World Health Organization (WHO) has declared the COVID-19 outbreak as a pandemic. The transmission of the virus occurred rapidly that 2 weeks from the first case diagnosed, 1000 patients tested positive. A week later, the number of positive cases exceeded 4600, reaching more than 30,000 patients and 2,500 deaths on March 18, 2020. The death rate due to COVID-19 in Indonesia is one of the highest in Asia. To date, no therapy has been shown to be effective for Coronavirus (SARS-CoV-2). A vaccine for SARS-CoV-2 also has not been found at this time and is in the research phase. Current management of COVID-19 patients focuses primarily on providing supportive care. Currently, several countries make treatment guidelines for COVID-19 patients by providing several types of anti-viral drugs and other drugs such as chloroquine or hydroxychloroquine, immunoglobulins, anti-cytokine agents or immunomodulators. The administration of these drugs does not escape the various side effects experienced by patients. Administration of chloroquine or hydroxychloroquine carries the risk of causing prolonged QT interval which can lead to arrhytmia disturbances such as torsades des pointes in certain people. Administration of chloroquine or hydroxychloroquine in combination with azithromycin increases the risk of developing arrhythmias. Giving anti-viruses such as lopinavir / ritonavir, umifenovir, remdesivir, favipiravir can also cause various side effects including gastrointestinal disturbances (nausea, vomiting, diarrhea), impaired liver function, and hyperuricaemia. Treatment with human immunoglobulins has been associated with a significantly increased risk of thrombotic events. Currently, no acupuncture research on COVID-19 patients has been published. However, acupuncture can play a role in several conditions that occur in COVID-19 according to the pathophysiology that occurs, this has been proven through several clinical studies conducted on non-COVID-19 cases that have pathophysiology that resemble COVID-19 conditions. In COVID-19 with mild-moderate symptoms, acupuncture can play a role in boosting the immune system, including increasing the number of Natural Killer cells and lymphocytes. Whereas in cases of severe COVID-19 symptoms, it is hoped that acupuncture can provide anti-inflammatory effect and prevent cytokine storm.
This study is a multicenter, prospective, placebo-controlled, comparative, randomized, double-blind local phase II clinical trial. Duration of study is 18 months. In the study, patients will be randomized in a ratio of 1: 1 into two arms, standard medical therapy + placebo versus standard medical therapy + inhaled Aviptadil arms. Randomization will be carried out by the block randomization method. In the event that patients need intensive care in the study, the patients will be taken into intensive care unit and excluded from the study and their treatment will be continued in the intensive care unit as deemed appropriate by the physician and it is foreseen that inhaled Aviptadil will be used for a period of minimum 7 and maximum 14 days. Aviptadil will be discontinued in patients who do not heal after 14 days. This study includes 8 visits, consisting of a total of 7 physical visits and 1 phone follow-up visit. The study period will be 6 months for each patient. Patient recruitment is planned to take 12 months. Study centers will be asked to use investigational products for their patients who sign the informed consent form for 12 months. The study population will consist of patients 18 years of age and older with COVID-19 pulmonary involvement and hospitalized patients.
The present COVID-19 Virtual Reality (COVVR) clinical study is performed to test the hypothesis that an immersive virtual reality (iVR)-based Digital Therapeutics (DTx), would alleviate dyspnea by improving breathing comfort in patients recovering from COVID-19 pneumonia presenting with persistent dyspnea. We will further evaluate participants' perceived awareness of and agency over their breathing movements. Finally, we will track patients' perceived benefits related to the iVR intervention and the feasibility of using COVVR in the clinic or at home.