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Covid19 clinical trials

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NCT ID: NCT04777981 Not yet recruiting - COVID-19 Clinical Trials

(CBDRA60) to Prevent or Reduce Symptoms of COVID-19 and Prevention of Post-Acute Sequelae of SARS-CoV-2 Infection PASC

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04768179 Not yet recruiting - Covid19 Clinical Trials

Safety & Efficacy of Low Dose Aspirin / Ivermectin Combination Therapy for Treatment of Covid-19 Patients

IVCOM
Start date: February 19, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

COVID-19, caused by the novel Severe Acute Respiratory Syndrome Corona Virus 2 (SARSCoV-2), has become a global pandemic. Fortunately, most of the COVID-19 cases confirmed are categorized as mild for whom home- based symptomatic management with monitoring of clinical deterioration is recommended. Despite providing symptomatic management, a therapeutic drug that would limit the course of infection is greatly needed to stop COVID-19 disease progression. Considering the current SARS-CoV-2 epidemiology and the legitimate rash towards appropriate therapies, our study seeks to evaluate the safety and efficacy of low dose aspirin and ivermectin combination therapy in COVID-19 patients.

NCT ID: NCT04766671 Not yet recruiting - COVID-19 Clinical Trials

An Exploratory Study to Describe Virological Effect, Safety, and Pharmacokinetics of VIR-7831 Monoclonal Antibody in Hospitalized Participants With COVID-19

COMET-ACE
Start date: April 14, 2021
Phase: Phase 2
Study type: Interventional

This is an exploratory study in which hospitalized participants with COVID-19 will receive VIR-7831 (GSK4182136) or matching placebo with assessments of virological effect, safety and pharmacokinetics (PK). The study will be comprised of two phases: The Lead-in phase and the Expansion phase.

NCT ID: NCT04757870 Not yet recruiting - COVID19 Clinical Trials

Macro-scale Estimators of Covid-19's Worldwide Cases and Deaths

Start date: March 1, 2021
Phase:
Study type: Observational

In this study, investigators try to estimate Covid-19 Cases and Deaths using countrywide annual macro-scale indicators (i.e., estimators) such as non-communicable disease data from WHO (who. int), social and economical indicators from UN (un.org) and Worldbank (worldbank.org), and Covid-19 Cases and Deaths from Worldometer (https://www.worldometers.info).

NCT ID: NCT04752839 Not yet recruiting - Depression Clinical Trials

Evaluation of the Psychosocial Impact on Health Professionals Exposed During COVID 19 Coronavirus Pandemic

Start date: February 2021
Phase:
Study type: Observational [Patient Registry]

Application of a survey in electronic support to hospital professionals. This survey will include different demographics as well as questions from own elaboration about the different aspects related to the development of work during the health emergency. A third part will be included different validated scales for screening / diagnosis of different problems that can present those who are working in the Current situation. The different scales are the PHQ-9, GAD 7, ISI, and EIE-R. These scales address the different problems that have been seen that can introduce professionals, Depression, Anxiety, Insomnia and adaptation to stressors.

NCT ID: NCT04751721 Not yet recruiting - Covid-19 Vaccine Clinical Trials

Oxidative Stress Parameters, Trace Element and Quality of Life in Women Before and After Covid-19 Vaccines

Start date: February 2021
Phase: N/A
Study type: Interventional

There is no effective treatment method for COVID-19 yet. With vaccination being the most effective approach to control the COVID-19 pandemic, vaccines have been developed with many different methods. One of the vaccines developed, the China-based CoronaVac vaccine (inactivated + aluminum adjuvant vaccine) is a vaccine developed with the inactive method, which is the classical vaccine production method. As a result of Phase 1, Phase 2 and Phase 3 trials, emergency use approval has been given for the CoronaVac vaccine by Turkish Pharmaceuticals and Medical Devices Agency. The clinical picture of COVID-19 can be heterogeneous, ranging from asymptomatic to severe disease, which can be associated with a cytokine storm. In the clinical results of COVID-19, it has been observed that the severity of the disease is lower in women than in men, and the mortality rates are lower in women than in men. A few studies have shown the physiological roles of some vitamins and trace elements in COVID-19. Investigation of free radical levels known to be effective in the development of cardiovascular disease due to oxidative stress is important in determining the risk of cardiovascular complications in the COVID-19 pandemic. In addition, the social isolation rules and quarantine measures applied in the COVID-19 pandemic have caused individuals to be negatively affected physically and psychologically and their quality of life to decrease. Investigating the changes in oxidative stress parameters, trace element and quality of life levels of vaccination in COVID-19 may provide useful information in determining the effects of COVID-19 vaccine. It is planned to include female individuals to be vaccinated in Izmir Bakırcay University Cigli Training and Research Hospital. Within the scope of the study, it was planned to determine the oxidative stress parameters, trace element levels and quality of life levels of the individuals and to compare the values of the data obtained before and after vaccination. After analyzing the data obtained from the research with appropriate statistical methods, the data will be evaluated.

NCT ID: NCT04751695 Not yet recruiting - Covid-19 Vaccine Clinical Trials

Oxidative Stress Parameters, Trace Element and Quality of Life in Men Before and After Covid-19 Vaccines

Start date: February 2021
Phase: N/A
Study type: Interventional

With the rapid spread of COVID-19 (SARS-CoV-2) disease all over the world and the announcement of a pandemic, research on many different drug approaches has begun and these researches continue today. Although measures such as social distance, quarantine and isolation are effective in reducing the spread of SARS-CoV-2 in the short term during the pandemic, there is no effective treatment method yet. It is known that especially healthcare workers, the elderly and individuals with underlying health problems are at high risk. However, gender differences in COVID-19 clinical outcomes are thought to exist, and there is growing evidence that the disease is more severe in men than in women and mortality rates are higher.With the global consensus that the most effective approach to control the COVID-19 pandemic is a vaccination that is effective in COVID-19, vaccines have been developed with many different methods. CoronaVac vaccine (inactivated + aluminum adjuvant vaccine) is a vaccine developed with the inactive method, which is the classic vaccine production method. After the completion of Phase 1 and Phase 2 trials of the vaccine, Phase 3 trials were initiated to investigate the effectiveness of the vaccine in 4 different countries, including Turkey. Emergency use approval has been given for the CoronaVac vaccine by Turkish Pharmaceuticals and Medical Devices Agency. Researching the effects of vaccination on oxidative stress parameters, trace element and quality of life levels in COVID-19 may provide useful information in determining the effects of COVID-19 vaccine. It is thought that the anti-inflammatory and antioxidant properties of some vitamins and trace elements may be associated with positive results in COVID-19 patients, and the physiological roles of these vitamins and trace elements in COVID-19 have been demonstrated by studies. It is important to investigate the levels of free radicals known to be effective in the development of cardiovascular disease due to oxidative stress, which can provide information on determining the risk of cardiovascular complications in the COVID-19 pandemic. In addition, the quality of life of individuals decreases in the COVID-19 pandemic.This study is planned to be carried out by including male individuals to be vaccinated in İzmir Bakırçay University Çiğli Training and Research Hospital. Determination of oxidative stress parameters, trace element levels and quality of life levels before and after vaccination applications to be applied to individuals within the scope of the study; It was planned to compare these data before and after vaccination. After analyzing the data obtained from the research with appropriate statistical methods, the data will be evaluated.

NCT ID: NCT04748471 Not yet recruiting - Clinical trials for Prevention of COVID19

Immunogenecity and Safety of VaccinemRNA-1273 in Elderly Volunteers (Over 65 y) Compared to Younger Ones (18-45y)

CoviCompareM
Start date: February 10, 2021
Phase: Phase 2
Study type: Interventional

This study aims to evaluate the immunogenicity of Moderna mRNA-1273 vaccine in volunteers aged 65 years or more compared to volunteers aged 18-45 years, over 24 months duration. It will provide necessary data on the early immunological response to the vaccine and its evolution in quantitative and qualitative terms. This study will allow establishing how aging influences the response to the vaccine and help to adapt the vaccinal plan. For instance it will suggest the necessity of a vaccination booster.

NCT ID: NCT04733651 Not yet recruiting - Covid19 Clinical Trials

Study to Investigate the Clinical Efficacy of Isoquercetin in Patients With COVID-19

Start date: February 20, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the clinical efficacy of Isoquercetin in preventing disease progression and symptoms improvement in mild-to-moderate hospitalised COVID-19 patients.

NCT ID: NCT04733170 Not yet recruiting - Covid19 Clinical Trials

Clinical Performance Evaluation of KnowNow SARS-CoV-2 Test for the Detection of COVID-19 Antigen

Start date: February 15, 2021
Phase:
Study type: Observational

This is an international, multicentre, non-interventional, observational study to assess the clinical diagnostic performance of a rapid, point of care (POC) COVID-19 (SARS-CoV-2) antigen In vitro diagnostic (IVD), The KnowNow SARS-CoV-2 Rapid Antigen Test, using saliva samples when compared to reverse transcription polymerase chain reaction (RT-PCR) as the standard detection of COVID-19 infection.