View clinical trials related to SAR.
Filter by:This clinical study is to investigate the safety and tolerability of CCT301-38 CAR modified autologous T cells (CCT301-38) in subjects with relapsed or refractory AXL positive sarcomas
Coronavirus disease (COVID-19), caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), presents a major threat to human health. SARS-CoV-2 is highly infectious and is associated with extensive morbidity and mortality. Our study shares important features with other clinical trials using supplements or other widely available medications (e.g., Ascorbic Acid, Zinc, Vitamin D, Vitamin C). Our study shares two important elements with these previous studies, including: 1. The use of adaptive and cost-effective study design methods, 2. The testing of prophylactic supplementation using known, natural substances that have demonstrated safety and limited side effects. The focus of this study is to use a supplement that combines Cannabidiol and Gigartina Red Algae in creating "CBDRA60", a sublingual tablet, which is hypothesized to help reduce the duration of symptoms in patients diagnosed with the novel coronavirus disease (COVID-19). The rationale and design of our trial (N=60), is as follows: 60 individuals newly diagnosed with COVID-19 infection will be randomized to one of two groups. They will either receive CBDRA60 (30mg CBD, 30mgRA / 60mg combo; 2x/daily with food or 120 mg total) or a placebo in a 1:1 ratio. The study duration will be 5 weeks. The primary outcome for newly diagnosed individuals is the prevention of disease progression which leads to hospitalization. The secondary outcome is a reduction in symptom severity scores. COVID-19 patients with weakened innate immune systems may be susceptible to more severe disease and higher mortality. An impaired host immune response may lead to higher SARS-COV-2 viral load and subsequent overactivation of the adaptive immune system that results in cytokine release syndrome. CBD and Gigartina Red Algae can modulate both the innate and adaptive immune responses, have anti-viral activity and thereby can suppress the consequent hyperinflammatory response. Viral infection activates a pathological inflammatory response to combat the pathogen and limit its spread. Viral pathogens, such as the severe acute respiratory syndrome (SARS) coronaviruses (SARS-CoV), and other viruses (such as HIV), have been linked to many human and animal diseases. Advancements in research over the past decade, has led to a better understanding of SARS-CoV biology and the mechanism by which this family of viruses, the coronaviridae, infect and enter the host cells (refs). SARS-CoV-2, a unique type of coronavirus, inhibits host defense by invading host cells, replicating, and infecting numerous tissues. Severe COVID-19 is associated with a cytokine storm, acute respiratory distress and consequent multiple organ pathology that can be fatal. This depictive storm is a result of increase in circulating levels of various proinflammatory cytokines including IL-6, IL-1 TNF-α as well as interferons (IFN-I; IFNα and IFNβ). CBD CBD is a non-psychotropic cannabinoid that has a broad spectrum of well-established anti-inflammatory and immunomodulatory effects. For example, CBD administration in a murine model of lung injury, reduces lung inflammation through inhibition of immune cell cytokine production and suppression of leukocyte infiltration. Our premise is that similar CBD-induced effects would be highly applicable and hugely beneficial to mitigating the acute respiratory distress syndrome observed in COVID-19. Published evidence also indicates that CBD can inhibit viral replication. Red algae (Rhodophyta) are known for their potent anti-viral properties, non-toxicity and for being well tolerated in humans. Rhodophyta contain several sulfated polysaccharides that exhibit high antiviral activity against enveloped viruses, including important human pathogens such as herpes simplex virus (HSV), human cytomegalovirus, dengue virus and respiratory syncytial virus. Sulfated polysaccharides can exert their anti-viral effects through interacting with the external glycoprotein of the virion envelope preventing attachment of the virus to cell surface receptors. Red algae also contain mannose specific lectins that specifically interact with viral envelope glycoproteins including the spike glycoprotein specific to SARS-CoV2 to inhibit viral entry. It is our premise that by using a safe and tolerable dose of the formulated CBDRA60 sublingual tablet, participants could either be protected from viral infection of the SARS-CoV-2 virus (COVID-19) or in subjects that are already infected, CBDRA60, could prevent virus attachment, mitigate virus-induced inflammation and avoid a cytokine storm, enabling a faster recovery.
HYPOTHESIS: The administration of vitamin D supplements to patients who have a positive diagnosis for SARS-Cov-2, acute pneumonia requiring hospital admission and vitamin D deficiency have a more favourable evolution than subjects not treated with vitamin D (placebo). This favourable evolution will translate into a reduction in mortality, fewer ICU admissions and fewer days of stay in hospital. OBJECTIVES: PRINCIPAL: To assess whether the group of patients receiving vitamin D supplements have a less severe evolution of their acute pneumonia, translated into lower mortality, than patients who do not receive that supplement. SECONDARY: 1) To determine the number of intensive care admissions and the number of days of admission in both groups (control group and intervention group). 2) To estimate the prevalence of Vitamin D deficiency in the patients studied and the effectiveness of its supplementation. 3) To establish the degree of complexity of each study group and carry out a cost-effectiveness study. METHODOLOGY: DESIGN: Clinical trial, randomized, placebo-controlled and double-blind, with two parallel groups The active treatment will be vitamin D (Hydroferol soft capsules of 0.266 mg). The placebo will consist of a tablet with the same external characteristics and with the same treatment scheme but which will not contain any vitamin D active ingredients.
This is a phase 1 clinical trial to verify the safety and efficacy of DW-MSC in COVID-19 patients. A total of 9 subjects are randomly allocated. Subjects who meet the final inclusion and exclusion criteria are randomized to the test groups (low-dose group and high-dose group) or control group (placebo group) in a ratio of 1:1:1. Subjects assigned to the test groups were administered intravenously once with 5 x 10^7cells of DW-MSC for the low-dose group or 1 x 10^8cells for the high-dose group after registration. Subjects assigned to the control group were administered with placebo in the same manner as the test drug (DW-MSC). At this time, all of the existing standard co-treatment are allowed. DW-MSC is adjunct therapy to standard therapy. This clinical trial is a double-blind trial, in which a randomized method will be used. To maintain the double-blindness of the study, statistician who do not participate in this study independently generate randomization code. Subjects will be randomized to the test groups (low-dose group and high-dose group) or the control group (placebo group) in a 1:1:1 ratio. After the completion of the trial, the randomization code will be disclosed after unlocking the database and unblinding procedures. Follow Up period: observed for 28 days after a single administration
The objective of this clinical trial was to assess the efficacy and safety of cetirizine HCl syrup vs. loratadine syrup vs. placebo syrup in the treatment of SAR in children 6 to 11 years old.
The purpose of this study is to assess the safety and efficacy of an investigational nasal aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis in children (6-11 years of age).