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Covid19 clinical trials

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NCT ID: NCT06452095 Not yet recruiting - Long COVID Clinical Trials

Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine Trial - Effect of Hyperbaric Oxygen Therapy for the Treatment of Post COVID Condition

RECLAIM - HBOT
Start date: July 15, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The RECLAIM study platform will be used to explore whether the use of Hyperbaric Oxygen therapy (HBOT) may be used to improve the symptoms of post covid condition. Hyperbaric oxygen therapy is a well-established medical treatment. HBOT promotes healing by delivering a high concentration of oxygen into the body. This high level of oxygen has a number of known benefits, such as growth of new blood vessels, as well as regulating immune and inflammation responses. It helps protect the brain and other nervous tissue from inflammation. HBOT may also have antiviral effects. Collectively, it has the potential to target the underlying mechanisms believed to play a critical role in the development of Long COVID. Many patients with Long COVID complain of fatigue, brain fog, muscle aches and other symptoms. There is evidence to suggest that these symptoms may be a problem with the blood vessels, resulting in abnormal delivery of oxygen to tissues. Thus, our group is investigating whether HBOT's ability to improve the delivery of oxygen to tissues may help these symptoms.

NCT ID: NCT06452069 Not yet recruiting - COVID-19 Clinical Trials

Efficacy and Safety Study of Essential Oil-Based Preparation Administered to COVID-19 Patients

Start date: September 15, 2024
Phase: N/A
Study type: Interventional

The aim of this study was to compare the efficacy and safety of the essential oil-based product in patients with mild to moderate symptomatic COVID-19 Positive infection confirmed by PCR. A computational simulation approach of the molecular interaction (binding) of the main components of essential oils exhibiting antiviral activity with known intracellular protein targets of SARS-CoV-2 (nsp5: Main Protease) was adopted as a rationale for this study. SARS-CoV-2, a single-stranded RNA virus, has four major structural proteins Spike (S), Membrane (M), Envelope glycoprotein (E) and Nucleocapsid (N) protein and non-structural proteins (nsp). These non-structural proteins, of which there are 16 in total in the genome of the virus, play key roles in the mechanisms of the virus life cycle, including replication, transcription, protein synthesis and modification of RNA. Main protease (Main protease, Mpro, 3CLpro), virus Since they are directly involved in the maturation of these nsp proteins, which have an important role in many mechanisms of the life cycle, they have been the target enzyme in the development of new antiviral drugs for the treatment of COVID-19. In this study, our main rationale is to investigate the effect of essential oils on nsp5: Main Protease enzyme activations.

NCT ID: NCT06441968 Not yet recruiting - COVID-19 Clinical Trials

Safety and Immunogenicity Trial of MPV/S-2P SARS-CoV-2 Vaccine in Adults

Start date: June 18, 2024
Phase: Phase 1
Study type: Interventional

A clinical trial to evaluate the safety, reactogenicity, and immunogenicity of MPV/S-2P administered intranasally to adults who have previously received a primary series and at least one booster with an authorized or licensed mRNA SARS-CoV-2 parenteral vaccine. The primary objective is to evaluate the safety and reactogenicity of a single dose of MPV/S-2P in previously vaccinated healthy adults.

NCT ID: NCT06436911 Not yet recruiting - COVID-19 Clinical Trials

To Evaluate Safety and Immunogenicity of a Prophylactic Plasmid DNA

VAX-002-01
Start date: July 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Currently, several vaccines are available to combat the COVID-19 pandemic. The persistence of SARS-CoV-2 globally requires the development of additional vaccines to aid in preventing further SARS-CoV-2 infections. Covigenix VAX-002 is a vaccine based off its predecessors VAX-001 and VAX-001-1b. All three are plasmid DNA vaccines that express key antigenic determinants from SARS-CoV-2 and use the Entos Pharmaceuticals' Fusogenix proteo-lipid vehicle (PLV) platform. Currently, the safety and tolerability of VAX-001 and VAX-001-1b for primary vaccination following 1 or 2 doses are being investigated in a Phase 1/2 study (ENTVAX01-101). In Phase 1, VAX-001 was administered to healthy adults on Day 0 and Day 14, as either 2 low doses (100 μg/dose) or 2 high doses (250 μg/dose). Overall, data suggest that VAX-001 is safe at both the low and high dose levels. The Phase 2 part evaluates VAX-001-1b in adults at a 100 μg dose level on a 1-dose and a 2-dose schedule (Days 0 and 28). An interim analysis conducted on data from 18 participants in the sentinel group who had received their first dose of 100 μg showed that VAX-001-1b was overall safe with minor adverse events (AEs) registered. No serious adverse events (SAEs) were reported. After a review of the data, the Data Safety Monitoring Committee (DSMC) provided their recommendations for the participants in the 100 μg dose sentinel group to receive a second dose. The present study investigates the safety and immunogenicity of VAX-002 when given as a booster dose to generally healthy adults aged 18 years or older who have received a primary vaccination course or a booster dose of an authorized COVID-19 vaccine at least 3 months prior to Day 0. VAX-002 was specifically designed to address the new circulating omicron variants of SARS-CoV-2. The study consists of 2 parts: a dose-finding/safety evaluation part (Phase 1) to determine the dose of VAX-002 for booster vaccination (100 μg or 250 μg) followed by an adaptive Phase

NCT ID: NCT06434701 Not yet recruiting - COVID-19 Clinical Trials

Severe COVID-19 Infection in Children Presenting to EDs in Israel and England

SPICE
Start date: September 30, 2024
Phase: N/A
Study type: Interventional

Even though the COVID-19 pandemic is no longer at its peak, the threat still lingers. Engaging in prospective surveillance studies will enable us to monitor the disease and prepare for any potential resurgence. COVID-19 surveillance studies are essential tools for policymakers to make informed decisions, allocate resources, and develop strategies to control the spread of the virus and protect public health. The objective of this surveillance study is to prospectively assess in-hospital severe morbidity related to COVID-19 infection in children who present to the Pediatric Emergency Department (ED). A prospective multicenter study will be conducted across eight EDs in Israel and five EDs in the United Kingdom. The study population will include children aged 16 years or younger with a severe acute COVID-19 infection. Confirmation of acute COVID-19 infection will be based on polymerase chain reaction nasopharyngeal swab testing. The study will also include patients diagnosed with multisystem inflammatory syndrome in children (MIS-C), as defined by the CDC.

NCT ID: NCT06424925 Not yet recruiting - COVID-19 Pandemic Clinical Trials

Use of Artificial Intelligence (AI) to Predict Clinical Outcomes in Patients Hospitalized for COVID19 Pneumonia During the 4 Pandemic Waves

AI COVID-19
Start date: June 1, 2024
Phase:
Study type: Observational

Predictive models can be applied in different areas, during the emergency of the COVID-19 pandemic, in fact, they have proven important in supporting health systems in planning strategic decisions and in formulating health policies for the containment of the disease. The Covid-19 pandemic, in particular, has represented a real challenge for our healthcare system. In Italy, it was divided into four main waves, each characterized by different types of patients and different therapeutic approaches progressively improved based on new scientific evidence. The objective is to carry out a study on the data of patients hospitalized for COVID-19 at the ASST of Lecco during all four pandemic waves, with different degrees of severity of illness, collecting the data of interest and applying it to they use artificial intelligence to identify recurring patterns of clinical outcome in terms of survival and secondary infectious complications, so as to build new reliable predictive statistical models that can be used to predict the outcome of the patients themselves. The strong ambition of this project is that the application of artificial intelligence to data of such significant quantity can allow us to build valid statistical models which can then be hypothetically applied to any patient to predict, based on anamnestic characteristics, blood chemical parameters. at baseline and at the set treatment, the probability of survival and complications

NCT ID: NCT06409663 Not yet recruiting - Clinical trials for Severe Acute Respiratory Syndrome Coronavirus 2 Infection

Phase 3 Strain Change Study for SARS-CoV-2 rS Vaccines

COVID-19
Start date: August 5, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Phase 3 study assessing the safety and effectiveness of a single dose of a SARS-CoV-2 nanoparticle vaccine (NVX CoV2705) adjuvanted with Matrix-M™ in previously vaccinated adults. About 100 participants will receive the vaccine and be monitored for safety and immune response for up to 35 days post-vaccination.

NCT ID: NCT06404411 Not yet recruiting - Long COVID Clinical Trials

The Efficacy of Aerobic Exercise in the Rehabilitation of Patients With COVID-19-Related Myocardial Injury

Start date: June 30, 2024
Phase: N/A
Study type: Interventional

A study of the efficacy of aerobic exercise based on cardiopulmonary exercise test in the rehabilitation of patients with COVID-19-related myocardial injury

NCT ID: NCT06404112 Not yet recruiting - Sleep Disturbance Clinical Trials

RECOVER-SLEEP: Platform Protocol, Appendix_B (CPSD)

Start date: July 2024
Phase: Phase 2
Study type: Interventional

The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple interventions and allows comparative analysis across the interventions. For example, objectives, measures, and endpoints are generalized in the platform protocol, but intervention-specific features are detailed in separate appendices. This platform protocol is a prospective, multi-center, multi-arm, randomized controlled platform trial evaluating potential interventions for PASC-mediated sleep disturbances. The hypothesis is that symptoms of sleep and circadian disorders that emerge in patients with PASC can be improved by phenotype-targeted interventions. Specific sleep and circadian disorders addressed in this protocol include sleep-related daytime impairment (referred to as hypersomnia) and complex PASC-related sleep disturbance (reflecting symptoms of insomnia and sleep-wake rhythm disturbance).

NCT ID: NCT06404099 Not yet recruiting - Long COVID Clinical Trials

RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)

Start date: July 2024
Phase: Phase 2
Study type: Interventional

The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple interventions and allows comparative analysis across the interventions. For example, objectives, measures, and endpoints are generalized in the platform protocol, but intervention-specific features are detailed in separate appendices. This platform protocol is a prospective, multi-center, multi-arm, randomized controlled platform trial evaluating potential interventions for PASC-mediated sleep disturbances. The hypothesis is that symptoms of sleep and circadian disorders that emerge in patients with PASC can be improved by phenotype-targeted interventions. Specific sleep and circadian disorders addressed in this protocol include sleep-related daytime impairment (referred to as hypersomnia) and complex PASC-related sleep disturbance (reflecting symptoms of insomnia and sleep-wake rhythm disturbance).