Active clinical trials for "COVID-19"

The coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due to enhanced infection prevention practices or whether pwCF has protective genetic/immune factors. This study aims to prospectively assess the proportion of pwCF, including both adults and children with CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This study will also examine whether pwCF who have antibodies for SARS-CoV-2 have a different clinical presentation and what impact this has on their CF disease. The proposed study will recruit pwCF from paediatric and adult CF centres in Europe. Serological testing to detect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points if bloodwork is available via normal clinical care. Clinical data on, lung function, CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology and vaccination receipt, will be collected during routine clinical assessments. Associations will be examined between sociodemographic and clinical variables and serologic testing. The effects of SARS-CoV-2 infection on clinical outcomes and analyze end-points will be examined to explore any age-related or gender-based differences, as well as a subgroup analysis of outcomes in lung transplant recipients and pwCF receiving CFTR modulator therapies. As pwCF receive COVID-19 vaccination a comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 over time will be performed.

VIDO has developed a vaccine called COVAC-1. The COVAC-1 study vaccine contains a portion of the SARS-CoV-2 spike protein, called S1. The spike protein is the part of the virus that is responsible for attaching to the surface of host cells. COVAC-1 contains a TriAdj adjuvant. An adjuvant is a compound that is added to a vaccine to help the vaccine produce a better immune response. The vaccine is expected to stimulate the body to make antibodies against the S1 protein. The antibodies will recognize the viral spike protein if the body is exposed to the virus and prevent COVID-19 illness. In animal studies, the immune response generated by the COVAC-1 vaccine was able to protect the vaccinated animals against a severe SARS-CoV-2 infection. The COVAC-005 Study is a Phase I, multi-centre trial of a SARS-CoV-2 vaccine booster. This is a randomized, observer-blinded, and placebo-controlled study to assess the safety and immunogenicity of COVAC-1 booster dose administered once in generally healthy adults 18-65 years of age who have received a minimum of 2 doses of an authorized COVID-19 vaccine at least 4 months prior to Day 0. The study will follow a dose-escalation design to test the safety and immunogenicity of three dosage levels (10, 25 and 50 µg). In each dose escalation group participants will be randomized in a 3:1 ratio, to receive either the investigational product or a placebo, respectively. Stratification will be according to the Investigational product dose received. Sub-analysis will be completed in two age groups, 18-54 and 55-65 years. Study participants will be initially randomized to the lowest dose of 10 µg or placebo. After approval by the Sponsor and based on the recommendations from the DSMB following the Day 7 safety analysis, new study participants will be allowed to be randomized in the higher dose escalation group of 25 µg. Approval will also be sought from the Sponsor, based upon the DSMB recommendation, to proceed with the higher dose of 50 µg. Within each dose escalation group of 16 participants (12 active vaccine recipients, and 4 placebo recipients) it is proposed to randomize a first cohort of 4 participants, including at least 3 active vaccine recipients, and pending no holding rule is met after 48 hours, as determined by the post-injection phone call, the remaining 12 participants within that dose escalation group will be randomized.

The long-term impact and effects of COVID-19 are still being determined. However, what is clear, is that some people are still struggling following a period of illness with COVID-19. Now known as 'long covid' or 'post covid-19 syndrome', people are not only experiencing physical symptoms like fatigue and breathlessness, but also psychological difficulties, as well as cognitive changes often referred to as 'brain fog'. This can include symptoms, such as changes in memory, difficulties with organisation and problem solving, as well as the ability to concentrate. Evidence from other research areas suggest that these changes could be due to shrinkage in areas of the brain that control functions like memory and concentration. There are also connections between different brain areas that work together to perform tasks such as remembering and concentrating, and these areas may also be affected by COVID-19. The purpose of this study is to scan the brains of patients reporting cognitive changes having been hospitalised with COVID-19 infection to see if any of these areas or connections have changed after infection and whether this might explain these cognitive changes.

Despite the SARS-CoV-2 virus being present worldwide, and although it is now clear that children are affected by the disease with milder symptoms than adults, many immunological questions, which are very relevant for Public Health reasons and for the organization of services, remain unsolved. The role of serology for the diagnosis of COVID-19, particularly in the pediatric age, is still very uncertain. Preliminary evidence suggests that not all children with SARS-Cov-2 infection develop antibody levels that can be detected by currently employed methods. This makes it crucial to identify other methodologies that are able to evaluate the true prevalence of prior SARS-CoV-2 infection in the pediatric population. Many other aspects of the immunological mechanisms of response to SARS-CoV-2 are also uncertain, such as the role of cellular immunity, and generally the role of immunity (cellular and antibody) in protecting against the disease in the medium and long term. Finally, questions remain open regarding cross-immunity with other previously circulating coronaviruses and their impact on the pediatric population in terms of protection against COVID-19 infection, disease development, or reinfection. This study aims to help clarify the role of serology and other immune response tests in the diagnosis of COVID-19 in the pediatric population. Specifically, it aims to assess: the prevalence of SARS-CoV-2 seroconversion cases among the pediatric population accessing the National Health System (NHS), at different moments in time and in different regions of Italy; whether cellular immunity tests can help to identify children who have had SARS-CoV-2 infection, particularly children with low antibody levels, and thus to better estimate the prevalence of prior SARS-CoV-2 infection; the prevalence of cross-reactivity with other coronaviruses; whether immunity (antibody and cellular) is protective in the medium/long term; and if there are healthy carriers, i.e. individuals who have had prior SARS-CoV-2 infection, who are asymptomatic but may harbor SARS-CoV-2 in the pharynx, with the risk of transmitting it.

To evaluate the efficacy of subcutaneous ropeginterferon alfa 2b ( P1101 combined with standard of care (SOC) compared with standard care alone in adult COVID-19 patients with comorbidities.

Researcher want to compare and evaluate the effect of sugammadex on postoperative recovery, with a focus on the occurrence of postoperative urinary dysfunction, in patients who have undergone regular abdominal surgery within a year of being infected with and treated for COVID-19. Post COVID-19 condition is a new and poorly understood clinical syndrome with potentially significant and life-altering consequences. Recent studies suggest that patients who have recovered from COVID-19 may experience autonomic dysfunction and be at risk for autonomic dysregulation/syndrome. In most patients undergoing general anesthesia, neuromuscular blockers are used, and their residual effects delay the recovery of autonomic function after surgery, leading to problems such as worsening bladder and bowel function. Therefore, reversal agents are used to aid in postoperative muscle recovery, with sugammadex and neostigmine being commonly used in clinical practice. While sugammadex is generally expected to result in faster postoperative recovery, limited reports exist on its effectiveness in patients who have recovered from COVID-19. This study aims to verify whether sugammadex is more effective than neostigmine in aiding the recovery of bowel and pulmonary function after surgery in patients who have recovered from COVID-19.

The purpose of this observational research study is to better understand immune responses to vaccines against viruses (influenza or SARS-CoV2). The goal is to determine any differences in immune responses to vaccines in uninjured people and in people living with spinal cord injuries, who are typically at increased risk of infections.

Many post COVID-19 patients suffer from cognitive deficits, even after 1 year after hospitalization. These complaints have a huge impact on psychological well-being and quality of life. In rehabilitation programs in the Netherlands, most interventions are based on physical therapy or learning how to cope with fatigue and low levels of energy. In former studies computerized training of cognition in other populations has been proven to be effective. Knowledge on the effect of computerized training on attention and working memory in patients suffering from COVID-19 is urgently needed, and may contribute to more evidence-based rehabilitation programs for these patients. Therefore the effectiveness of computerized training of attention and working memory in post COVID-19 patients with cognitive complaints will be studied in this study.

Aim of this study will evaluate the Impact of Covid-19 vaccine on Safety and Efficacy of Hematological Patients Received Allogeneic Hematopoietic Stem Cell Transplantation.

This study is a prospective, multicentric, observational test negative design study on adults hospitalized for Severe Acute Respiratory Infection (SARI), regardless of their vaccination status.