Active clinical trials for "COVID-19"

This project aims to investigate executive functioning abilities (primary outcome) and quality of sleep (secondary outcome) in patients with COVID-19 (while distinguishing between those with and without sleep fragmentation), compared with an age- and education matched control group of healthy individuals who did not experience contagion. Prefrontal electrical activity will be recorded with EEG in patients, and related to sleep and cognitive-executive metrics. The main questions it aims to answer are: is executive functioning impaired in COVID-19 patients compared with individuals who were not infected? is there a relationship between altered sleep and impaired executive functioning in COVID-19 patients? is such relationship related to altered prefrontal brain activitity in COVID-19 patients?

A Phase 3 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19

This is a multi-center, randomized, parallel controlled, double-blinded clinical trial to evaluate the effectiveness and safety of Hydrogen-Oxygen Generator with Nebulizer for adjuvant treatment of COVID-19 patients. The test group is expected to be superior to the control group in the primary endpoint (percentage of subjects achieving clinical recovery at Day 7 of study treatment). Subjects in the test group will receive treatment by using Hydrogen-Oxygen Generator with Nebulizer (manufactured by Shanghai Asclepius Meditec Co., Ltd., flow rate: 3L/min) combined with conventional basic supportive treatment (symptomatic support treatment determined by the investigator based on the condition of the subjects); and subjects in the control group will receive treatment by using Medical Molecular Sieve Oxygen Generator (manufactured by Shanghai Ouliang Medical Devices Co., Ltd., flow rate: 3L/min, provided by the sponsor) combined with conventional basic supportive treatment (same with that in the test group).

The goal of this observational study is to analyze binding antibody levels in adults in the United States (US) after receiving coronavirus disease 2019 (COVID-19) bivalent boosters (original and omicron BA.4/5) and updated COVID-19 vaccines (XBB.1.5).

An Open Comprative Study of the Prophylactic Efficacy and a Non-comparative Study of the Immunogenicity and Safety of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine (CoviVac) Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products" for Adults Aged 60 Years and Older

SARS-CoV-2 is a highly transmissible and pathogenic coronavirus that emerged in late 2019 and has caused a pandemic of acute respiratory disease, collectively known as COVID-19. Given the relatively short duration of protection after vaccination or SARS-CoV-2 infection and the evolution of immune-evading strains, it is likely that the population will have to be repeatedly boosted until a "universal" Pan-Sarbecovirus vaccine is available. SARS-CoV-2 protein subunit vaccine candidates have shown that, despite adjuvantation, their safety/reactogenicity profile seems to be preferable over mRNA or vectored vaccines, whilst inducing non-inferior immune responses (1,2). In this regard, serious adverse events of special interest from mRNA vaccines seem to be have been substantially underestimated/underreported. In a preliminary analysis by an International consortium, the true incidence seems to be 1,250/million excess risk in vaccinees instead of the 1-2/million reported by the Department of Health and Human Services (3,4). Additionally, in a recent study, the Clover SCB-2019 protein subunit vaccine candidate has shown higher neutralizing antibodies titers against the omicron variant, when compared to an inactivated vaccine (data not published yet). Although Brazil has various vaccine platforms authorized for emergency use or licensed, such as mRNA vaccines, vector-based vaccines, inactivated vaccines, so far Brazil has no access to adjuvanted or non-adjuvanted protein-based vaccines. This study will involve two vaccines registered in Brazil and a protein-based adjuvanted vaccine candidate, SCB-2019/Clover. Protein-based adjuvanted vaccines have the advantage of being from a known and licensed technology that can produce high quantities of vaccine at reasonable Costs of Goods. Protein-based adjuvanted vaccines have also been shown to be highly immunogenic, both in the context of COVID-19 (2,5) and other licensed vaccines (6), with long persistence of immunity and protection. Over 80% of the Brazilian population above the age of 18 years have received a full primary vaccination and another 7% at least one dose of vaccine. The overall booster coverage is about 48% (64% of the adults) (7). Anvisa has authorized 1st and 2nd booster doses of various vaccines in line with the MoH policy which was last updated in March 2022. It can be speculated that, like in other geographies, a third booster will be recommended soon, especially to at risk populations and in the scenario of high circulation of the Omicron BA.5 strain. This study will explore the immunogenicity, safety and reactogenicity of a booster dose of various platforms in fully primed individuals regardless of the number of booster doses they have received prior to the enrollment in the study. This mimics the "real world scenario" at vaccination centers where individuals with different background vaccination schemes show up for "a booster". It would facilitate logistics of immunization substantially if vaccines for boosting, independent of the immunization status, could be interchangeable with respect to safety/reactogenicity and immunogenicity. This study will enroll fully-primed individuals (2 doses of either Pfizer mRNA or Oxford/AZ/Fiocruz or Sinovac/Butantan or 1 dose of Janssen vaccine) who have received their last vaccine dose at least 4 months prior to study entry and who have received either no booster, or 1 or 2 boosters. Individuals will be stratified in cohorts by number of boosters and then randomized to receive one of 3 booster vaccines (AstraZeneca/Fiocruz, Pfizer/Wyeth, SCB-2019/Clover).

There is an increased lack of short- and long-term real-life effectiveness and safety data on new oral antivirals authorised and commercialised to treat COVID-19. To date, only two clinical trials have been published with data on the efficacy and safety of the use of the Paxlovid® and Lagevrio®. Since there is a public health, political, social and economic pressure to prevent severity, hospitalisation and death from COVID-19, monitoring the effectiveness and safety of commercialised oral antiviral therapies against COVID-19 has become emergent pharmacovigilance and public health task. The objective of the study is to monitor the post-marketing safety and effectiveness of the new oral antivirals indicated for the treatment of COVID-19, namely Nirmatrelvir/Ritonavir (Paxlovid®) and Molnupiravir (Lagevrio®), having as holders of the Authorization of Market introduction to Pfizer Europe MA EEIG and Merck Sharp & Dohme B.V., respectively.

The complex clinical symptoms of post COVID syndrome, especially chronic fatigue, pose a major challenge to patients and to the health care system and are frequently refractory to therapeutic intervention. There is increasing evidence that a dysregulated post-viral immune response may be involved in the pathogenesis of post COVID syndrome. In uncontrolled case studies, an improvement of fatigue symptoms after removing autoantibodies has been reported in post COVID patients. However, there is a lack of prospective, sham controlled studies. We initiate an interventional, randomised, sham treatment-controlled prospective study, the EXTINCT post COVID study, which aims to scientifically test the therapeutic efficacy of an extracorporeal apheresis procedure (immunoadsorption) for the treatment of a well characterized cohort of patients with post COVID syndrome, while at the same time providing basic research evidence for an understanding of the pathogenesis of post COVID syndrome. Thereby, we expect to obtain important insights into the diagnosis, treatment and pathophysiology of post-COVID syndrome.

Patients with Postural Orthostatic Tachycardia Syndrome (POTS) and Post-Acute Sequelae of COVID (PASC, or "Long COVID") experience cognitive dysfunction. The investigators will test the hypothesis that 1500mL of IV saline will improve cognitive function in patients with POTS and Long COVID, compared to placebo (50mL of saline).

This is an open-label Phase 3 study evaluating the immunogenicity and safety of Novavax vaccine(s) with Matrix-M™ adjuvant (ancestral strain NVX-CoV2373 and an alternative strain and/or multivalent Novavax vaccine) as booster doses following a series of primary and booster doses of authorized/approved mRNA vaccines followed by a single booster dose of NVX-CoV2373 in the Novavax 2019nCoV-307 study (Study 307).