Active clinical trials for "COVID-19"

The "Social network diffusion of COVID-19 prevention for diverse Criminal Legal Involved Communities" study will engage people who have been interacted with law enforcement in COVID-19 prevention (testing and/or vaccination) through social network mobilization combined with theory-driven COVID-19 prevention messaging delivered in an interactive group format. Eligible individuals will be enrolled into a two-arm 1:1 randomized controlled trial design. 800 participants will be enrolled into either a: 1) COVID-19 prevention education arm (Education Arm) or, 2) a network mobilization change agent intervention (Motivational Arm).

Observer-blind, randomized, active-controlled prospective intervention study of Immunogenicity & Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older.

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

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 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.

Oklahoma has high COVID-19 incidence, particularly among underserved minority and rural Oklahomans. Oklahoman's are also reporting SARS-CoV-2 vaccine hesitancy and signs of slowing vaccine uptake, with increased hesitancy among American Indian and rural populations. The project aims to work with ongoing community testing events to implement interventions to improve vaccine uptake among Oklahoma's underserved populations.

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.

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 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 study will examine the effectiveness of a 6-week behavioral intervention for patients who are recently diagnosed with COVID-19. Patients and their households will be randomized to one of two groups (Standard of Care vs. Enhanced Standard of Care). Patients in the Standard-of-Care group will receive established clinical care and follow-up. Patients in the Enhanced Standard-of-Care group will receive standard-of-care plus tailored, real-time text messaging and virtual counseling delivered by promotores/as. We hypothesize that households in the Enhanced Standard-of-Care group will have fewer (any new) household COVID-19 infectivity rates compared to households in the standard-of-care group post-intervention.