Active clinical trials for "COVID-19"

The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) for the Treatment of Coronavirus Disease 2019 (COVID-19) in participants with moderate to severe COVID-19.

The study aims to characterize the community burden (including the clinical features) and transmissibility of SARS-CoV-2 within the context of a functional antibody response. In addition,the study will assess the effect of the interaction of SARS-CoV-2 with influenza virus and RSV on disease severity and transmission dynamics. A household-level prospective cohort study will be conducted in one rural and one urban community located in Mpumalanga Province and North West Province, respectively. The study will be conducted for 12 months of intensive follow up (July 2020 to August 2021) with a post-intensive follow-up continuing for a further 16 months (until December 2022). Two hundred households; 1,000 study participants of all ages; will be randomly selected from a list of 327 hoseholds that participated and successfully completed a 10-months follow-up period in a study similar to that currently proposed, but directed at community burden and transmission dynamics of influenza, respiratory syncytial virus and other respiratory pathogens. Each household and household member will be enumerated and the HIV infection status and the level of immunosuppression of HIV-infected individuals will be assessed. Each household member will be followed twice per week during the intense follow-up period (12 months) of the study. During this period upper respiratory tract samples will be collected irrespective of presence of symptoms and data on key symptoms, healthcare seeking, hospitalization and death will be captured at each follow up visit. Respiratory samples will be tested by reverse transcriptase real-time polymerase chain reaction (rRT-PCR) for SARS-CoV-2, influenza and RSV, and selected samples will be cultured and sequenced. An infection risk questionnaire will be administered to all study participants at enrollment and every month thereafter. Sera will be collected at enrollment and every 2 months during the 12-month intense follow-up period from all participants. In addition, sera will be collected every 2 months for a further 6 months following the 12-month intense follow-up period from study participants that tested positive for SARS-CoV-2 by rRT-PCR on respiratory specimens at 14, 16 and 18 months and from all study participants at 18 months. Sera will be tested for the presence of SARS-CoV-2, influenza and RSV antibodies. Wearable proximity sensors will be deployed for 8-12 days in each household over the 6-month intense follow-up period.

This is an observational study of pooled population-based samples in three Nordic countries. Country-specific data has already been analysed in previous studies in Sweden, Finland, and Norway. The primary objective is to examine the association between tobacco use, the risk of SARS-CoV-2 infection, and adverse Outcomes using pooled population-based samples.

There is growing evidence that COVID-19 threatens maternal and perinatal health. Pregnant women are at higher risk of severe complications (severe pneumonia, hospitalizations, intensive care unit admission, invasive mechanical ventilation, extracorporeal membrane oxygenation) and death compared to age-matched non-pregnant women. On the other hand, the number of confirmed COVID-19 cases reported in sub-Saharan Africa (SSA) continues to increase, where the highest maternal mortality rates in the world are registered. The World Health Organization (WHO) estimates that this region alone accounted for roughly two-thirds (196 000) of all maternal deaths in 2017, which among other reasons is explained by the inequalities in access to quality antenatal care (ANC) services and the low numbers of skilled health workers in the region. The spread of SARS-CoV-2 in SSA is threatening the already fragile health services, affecting mainly the most vulnerable populations such as pregnant women. This project aims to describe the burden and effects of SARS-CoV-2 infection during pregnancy in women living in malaria endemic areas and high prevalence of HIV infection. Pregnant women attending ANC clinics in selected sites from Libreville and Lambaréné (Gabon) and Manhiça (Mozambique) will be enrolled in a cohort study to determine the frequency of SARS-CoV-2 infection and COVID-19 during pregnancy and its effects on maternal and neonatal health. Participants will be tested for SARS-CoV-2 infection whenever reporting respiratory symptoms suggestive of COVID-19 during routine ANC follow-up and six weeks after the end of pregnancy. The presence of antibodies (IgG/IgM) against SARS CoV-2 in blood samples will be determined. The clinical presentation of COVID-19 in pregnancy will be also characterised, and the incidence of infection during pregnancy and the risk factors of maternal and neonatal morbidity and mortality associated with SARS-CoV-2 infection and the frequency of mother- to- child transmission of SARS-CoV-2 will be assessed. The findings of this project will contribute to the understanding of the impact of SARS-CoV-2 and COVID-19 among pregnant women living in SSA countries where malaria and HIV infections are highly prevalent.

To understand the long-term epidemiology, develop effective risk-prediction and stratification tools, and understand the pathobiology of kidney disease in COVID-19 survivors.

The UpcomingVoice project aims to co-design a digital health solution based on vocal biomarkers for screening and self-monitoring of frequently reported COVID-19-related symptoms with its end-users: 1) people with persisting COVID-19 related symptoms, with or without a Long COVID diagnosis and 2) healthcare professionals involved in the care of Long COVID patients. To achieve this objective the UpcomingVoice study will determine: The needs, expectancies, acceptability, fears, barriers and leverages of the end-users regarding the use of voice to self-monitor or screen for Long COVID symptoms The specifications that such a mobile application should meet in order to be considered acceptable and effective by its intended users in terms of technological aspects (type of device, type of voice recordings…), frequency of utilisation, design etc. The project consists in 2 separate parts : one anonymous online survey and one qualitative part based on semi-structured interviews and focus groups. The results of this study will be the specifications of a voice-based digital health solution.

Prospective observational trial to assess immunological safety (anti-HLA antibodies, donor-derived cell-free DNA) and immunological effectiveness (anti-SARS-CoV-2 IgG) of the first booster dose of SARS-CoV-2 mRNA vaccines in kidney transplant recipients at least one year from transplantation.

Currently, 3 anti-SARS-CoV-2 monoclonal antibody products have received Emergency Use Authorizations from the Italian Medicines Agency (AIFA) for the treatment of mild to moderate COVID-19 in non hospitalized patients with laboratory-confirmed SARS-CoV-2 infection who are at high risk for progressing to severe disease and/or hospitalization (bamlanivimab plus etesevimab, sotrovimab, and casirivimab plus imdevimab). Differently from casirivimab/imdevimab and sotrovimab, the European Medicines Agency (EMA) has never recommended authorising the combination bamlanivimab/etesevimab for treating COVID-19. Moreover, the evidence on sotrovimab relies on the interim analysis results of an ongoing randomised placebo-controlled clinical trial [1], unlike the combinations bamlanivimab/etesevimab and casirivimab/imdevimab, whose results of the randomised placebo-controlled trials were published after having completed the enrolment [2,3]. The study aims at assessing the non-inferiority of bamlanivimab plus etesevimab and sotrovimab vs. casirivimab plus imdevimab on COVID-19 progression in patients aged at least 50 years at an early stage of the disease. The progression of COVID-19 disease (hospitalization, need for supplementary oxygen therapy at home, death) within 14 days of randomisation is the composite outcome variable on which the calculation of the sample size is based. Based on available data regarding the reduction in the number of hospitalisations and medical visits with the use of casirivimab plus imdevimab at an early-stage of COVID-19, a disease progression of 5% has been estimated in the reference arm. 5% delta margin was considered clinically relevant, taking into account both the estimates of disease progression in the study population in absence of early treatment with monoclonal antibodies (20%, based on national data) and the efficacy of the reference standard. Therefore, 1260 participants will be randomly assigned in an equal ratio between the reference standard and each of the other two experimental arms (1:1:1). Randomization will be computer-generated in permuted blocks with a stratification based on site.

Techfields Inc. is developing a new investigational prodrug as a topical spray, indicated for relief of the signs and symptoms of ARDS and pneumonia caused by COVID-19. This is a Phase 2, Multicenter, Randomized, Double-blind (Within Dose), Placebo-controlled, Parallel-group, and Dose-range-finding Study to Evaluate the Efficacy and Safety of Active drug Versus Placebo in Treatments for COVID-19 in Hospitalized Adults, relieving of the signs and symptoms of acute respiratory distress syndrome (ARDS) and pneumonia caused by coronavirus disease 2019 (COVID-19).

The COVID-19 pandemic has disproportionately affected people from underserved and vulnerable populations such as low-income/uninsured, unhoused, and immigrant communities. These populations in the US are at a higher risk of acquiring COVID-19 because of poverty, type of occupation, greater use of public transit, living in multigenerational housing, lack of access to quality healthcare, and more. Despite greater risk of being infected and dying of COVID-19, those in disadvantaged communities are less likely to get tested. The investigators are collaborating with community partners in Cumberland County, Maine to develop a public health intervention focused on making COVID-19 testing more acceptable and accessible to underserved populations. The intervention is based on qualitative formative research and includes a community-level communication campaign to make testing more acceptable and provision of at-home COVID-19 testing kits to make testing more accessible. In this study, the investigators will evaluate the impact of the public health intervention on COVID-19 testing behavior, knowledge and attitudes. The investigators will accomplish this aim by following a community cohort of 150 participants, with 15 participants from each of our 10 population groups of interest (three groups that access different health services for low-income/uninsured, unhoused individuals, and six different immigrant groups). The investigators will administer surveys to the cohort participants every other month over a 12 month period. The surveys will evaluate knowledge and attitudes towards testing and testing behavior. In order to ensure access to COVID-19 tests, the cohort participants will be provided at-home testing kits throughout the course of the study. The primary outcome of interest is "recommended testing behavior," which is defined as getting a rapid COVID-19 test when experiencing symptoms of COVID-19 or after a close contact exposure. The investigators hypothesize that knowledge about testing, favorable attitudes towards testing, and recommended testing behavior will increase as a result of participation in the study.