Active clinical trials for "COVID-19"

The term post-acute COVID-19 syndrome or Long COVID is a disabling syndrome that persists beyond the 3-month convalescence period after COVID-19 infections. This syndrome affects mostly women (~80%), present with chronic tachycardia and Orthostatic intolerance symptoms without any identifiable cause. In addition, non-specific symptoms such as fatigue, headache, and "brain fog", commonly described in POTS patients are also present in this novel condition, recently named post-COVID-19 tachycardia syndrome, POTS variant. Reduced Vagal activity and unresolved inflammation is post-COVID-19 POTS is hypothesized as the cause of Long COVID

This is an open-label, first-in-human, dose-finding study to evaluate the safety and immunogenicity of a booster vaccination of Prime-2-CoV_Beta in healthy participants who had received the full course of vaccination, including booster vaccination (i.e., having received 3 doses) with the Pfizer/BioNTech-BNT162b2 vaccine (Comirnaty).

The five recently emerged SARS-CoV2 variants that were designated as VOCs are the Alpha variant, Beta variant, Gamma variant, Delta variant and the Omicron variant. The current dominant Omicron variant was designated a VOC by WHO on Nov 26, 2021, and was found to comprise 85% of reported variants in late January 2022. Studies have shown that the prevalent Omicron mutations in the S1 subunit RBD region and NTD region could dramatically change the antigenic features of the viral spike, leading to significantly reduced neutralization Omicron harbors 30 signature mutations (>50% prevalence) of which 15 are in the S1 subunit RBD region and 8 are in the S1 subunit NTD region. Omicron is a highly contagious variant with threatening immune evasion capabilities even despite robust immune response. Initial modeling showed the Omicron variant being 2.8 times more infectious than the Delta variant. While current vaccines are losing protection against Omicron with respect to infection and mild disease, there is still considerable protection from hospitalisation and severe COVID-19, especially after a booster dose. The International Coalition of Medicines Regulatory Authorities (ICMRA) COVID-19 Omicron Variant Workshop encouraged the international scientific community and vaccine developers to look at alternative approaches to monovalent vaccines. In ICMRA's view, companies should also explore the feasibility of developing bivalent or multivalent variant vaccines to determine if they offer advantages to monovalent vaccines. As advised by ICMRA, the investigated vaccine, mRNA-1273.214 is a bivalent vaccine containing the ancestral SARS-CoV-2 and the Omicron variant spike sequences that will be evaluated as a heterologous boost.

Covid-19 has the potential to affect physical, cognitive and psychological functions in multiple ways. It has been clear that a significant proportion of patients with Covid-19 develop long-term symptoms. The term post COVID-19 condition (defined by WHO) is used to describe the wide range of prolonged symptoms following the infection. Patients may need specialized rehabilitation to be able to meet the complex symptoms and problems that may arise. A more specific syndrome that seems to occur more frequently than expected in the group of non-hospitalized patients with post COVID-19 condition is the postural orthostatic tachycardia syndrome (POTS). A randomized controlled design will be used to evaluate the effects of individual tailored physical exercise in patients with POTS after Covid-19. Participants: Adults (>18 years) with post COVID-19 condition and diagnosed with POTS (n=60) will be included. Exclusion criteria: known pregnancy, cancer, already ongoing individual physical exercise (specific for POTS), or not able to perform measurements and/or intervention. Procedure and outcomes: The primary outcomes are objectively measured time in upright position and health-related quality of life. Secondary outcomes are: physical activity, physical capacity, work ability and disease specific symptoms measured with tests and questionnaires. Prior to randomization baseline measurements will be performed, aswell as after 16 weeks, 6 months and 12 months. Intervention: Participants randomized to intervention will receive standard care and undergo a individually designed physical exercise program during 16 weeks, supervised and guided by a physiotherapist. The intervention will consist of different exercises to enhance muscle strength and endurance. Progression will be according to a program (based on previous feasibility studie) but should be halted if post exertional malaise (PEM) or other problems occur. Controls: Participants randomized to control will receive standard care during 16 weeks. Measurements of both groups (control and intervention) will be repeated after completion of a period of 16 weeks.

A phase III, open label, single arm, multi-centre, trial to assess the immunogenicity and safety of an additional dose vaccination with a recombinant protein RBD fusion heterodimer candidate (PHH-1V) against SARS-CoV-2, in adults with pre-existing immunosuppressive conditions vaccinated against COVID-19

This is a randomized, observer blind, controlled phase I/II study to evaluate the Safety, Reactogenicity, and Immunogenicity of UNAIR Inactivated Covid-19 Vaccine in Healthy Populations Aged 18 Years and Above. UNAIR Inactivated Covid-19 Vaccine is an inactivated vaccine developed by Airlangga University (Universitas Airlangga / UNAIR) made of SARS-CoV-2 virus isolated from a patient in Surabaya, Indonesia, composed with aluminium hydroxy gel, tween 80, and L-histidine. This study will be the first in human.

COVID-19 vaccines are limited in supply, especially in low- and middle-income countries, leading to substantial morbidity and mortality. Despite the COVID-19 Vaccines Global Access (COVAX) Facility initiated by the WHO to provide vaccine access for low-income countries, probably 80% of the vaccine needs of participating countries will not be met soon. In addition, there is an increasing demand for revaccination of the population globally, because of waning immunity which will further limit vaccine supplies. Exploring dose-sparing techniques, could therefore provide the solution to immunise more people with the same vaccine stockpile. The intramuscular injection (IM) is the standard inoculation route of vaccines. However, the skin (dermis) is much richer in antigen presenting dendritic cells than muscle. As a consequence, a fractional vaccine dose introduced directly into the dermis (intradermal administration, ID) might be as effective as the intramuscular administration of the full standard dose to achieve a protective immune response. This principle has recently been demonstrated for the ID dermal delivery of one-fifth fractional dose mRNA-1273 (Spikevax, Moderna) vaccine. However, needle-based immunisation has several limitations. Fear of needles makes immunisation a stressful event. In addition, needle stick injuries, as well as unsafe injection practices carry serious health risks. Therefore, the development of needle-free delivery has been identified as an important goal in global health care. The WHO reported that microneedle vaccine delivery is top priority and requires additional research to explore the benefits in more detail. A big advantage of intradermal delivery via a solid needle patch is not only the absence of needles and pain since no nerves are at the proximity where the needles are presented, but also the local delivery close to immune cells as with the above mentioned intradermal injection enables a much lower dose as compared to IM dosing. And since with the patch a larger skin surface is involved as compared to intradermal injection, even lower doses are possibly still immunogenic. In this study, we will investigate the immunogenicity and safety in healthy volunteers of the needle-free intradermal delivery of a single fractional dose of 20µg mRNA-1273 LNP vaccine (Spikevax, Moderna) more than 3 months after primary vaccination with Comirnaty (Pfizer) vaccine and/or after having contracted COVID-19.

This is an open-label, randomized, parallel-controlled clinical trial conducted in people aged 18 years and older to evaluate the immunogenicity and safety of two SARS-CoV-2 bivalent vaccines constructed by adenovirus type 5-based or mRNA-based technics.

The current standard of care for diagnostic of SARS-CoV-2 infection involves sample collection which is then prepared and measured via real time-polymerase chain reaction (RT-PCR). This process is time consuming and dependent on expensive instrumentation and trained technicians to perform both the sample preparation and assay. In many cases, sample turn-around times can take hours to several days. There are no established monitoring nationwide protocols for COVID-19 prevention of infection. Due to the lack of such protocols, this study will provide the proper experience to design a safe monitoring schema of asymptomatic cases of COVID-19. Self-testing using currently available RDT has a high specificity and relatively high sensitivity to identify individuals with a high probability of contagiousness. Therefore, we intend to use these RDT (Rapid diagnostic tests) for other use. There are several studies that point to the importance of the use of RDTs to monitor COVID-19 (3). The recent metadata indicate that the performance of the antigen test is crucial for obtaining good results to detect positive cases. We have already validated in the laboratory and using relevant clinical samples several different labels of antigen tests and we have compared them with already approved USA FDA antigen tests to confirm their performance prior to using them in this study. This project aims to monitor once a week the presence of SARS CoV-2 antigens using anterior nares (AN) swab self-process, executing the test and recording of the result, immediately after. The lack of affordable diagnostic tests which can detect the presence of SARS-CoV-2 in the general population which can give near real-time results is one critical missing control intervention in USA for the control of the pandemic and the spread of this disease. As public health restrictions begin to ease and people return to normal activities, while the COVID-19 pandemic is still a threat, a rapid diagnostic assay that does not require the sophisticated laboratory equipment and techniques could provide a significant advantage to screen asymptomatic individuals. The routine use of such rapid tests is a key element to show efficacy of protocol. We adjusted to once a week testing based on the medium to low risk of the elderly population of this study. The list of rapid nucleoprotein tests utilized in the current study are: NETO Corona test, Novir INSTA-TM COVID-19 Rapid Antigen test, COVICHEK COVID-19 Ag Test, SpectraBiotech COVID-19 track antigen test, Blandford Biotech AS-15™ Rapid Antigen Detection Kit SARS-CoV-2 Test (Colloidal Gold Method), Abbott BinaxNow tests. BACKGROUND The SARS-CoV-2 Direct Antigen Rapid Test ("Lateral flow") is an immunoassay developed for the qualitative detection of SARS-CoV-2 viral particles/secreted protein in anterior nasal swabs and/or saliva samples from both asymptomatic and suspected participants with COVID-19 infection. Lateral flow strips are printed with a monoclonal antibody that binds the signature SARS-CoV-2 viral particles/protein (Test line) and a control antibody (Control line) for quality control. A second monoclonal antibody is attached to gold nanoparticles (conjugate) and quencher buffer, and mixed with the nasal sample. The SARS-CoV-2 nucleocapsid protein attach to both antibodies resulting in a visual line on the test strip within 15 minutes. Prior experience in the detection of virus and viral proteins via antibody binding using lateral flow have been done through IDx20, Inc. The Housing Authority and the Public Health Department of the City of Chelsea will be overseeing this study.

COVID-19 is an infectious disease caused by SARS-CoV-2 virus, causing millions of deaths around the globe since the beginning of the pandemic. COVID-19 vaccination was proven to be effective at reducing both mortality and development of severe COVID-19 after infection. Vaccine-elicited protection is particularly important for immunocompromised patients, as they are more susceptible to infections with their defective immune response, for instance, previous review had suggested that patients with malignancies and recipients of solid organ transplants may be at increased risk of developing severe COVID-19 disease and even death. To further complicate the scenario, there are two obstacles: firstly, immunocompromised individuals may have suboptimal response from vaccinations, as studies have shown that recipients of solid organ transplant have suboptimal or even are seronegative after the fourth dose booster vaccination . Secondly, with constant mutation of the SARS-CoV-2 viruses, new variants evolve over time, leading to reduction in vaccine efficacy and breakthrough infection in healthy individuals. Therefore, novel vaccine strategy should be considered to enhance the vaccine response in these immunocompromised individuals. In this study, intradermal injection instead of intramuscular injection for vaccine delivery is proposed, as the investigators have observed improved immunogenicity and few adverse events from previous experience of influenza vaccination. The study aims to evaluate the immunogenicity, safety and tolerability of intradermal COVID-19 vaccination in immunocompromised patients.