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Covid19 clinical trials

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NCT ID: NCT05812586 Active, not recruiting - COVID-19 Clinical Trials

Assessment of Immunogenicity, Safety and Reactogenicity of a Booster Dose of Various COVID-19 Vaccine Platforms in Individuals Primed With Several Regimes.

Start date: March 14, 2023
Phase: Phase 3
Study type: Interventional

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).

NCT ID: NCT05794412 Active, not recruiting - Clinical trials for SARS-CoV-2 Infection

Mucosal Immunity: Influence on Infectious Viral Load: a Prospective Observational Study

MIViral
Start date: January 10, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about the influence of pre-existing mucosal immunity, i.e. antibodies and immune cells that are present at the nasal mucosa before infection, on the infectious viral load after infection with SARS-CoV-2, influenza virus and RSV. The investigators will include app. 320 participants which will be followed for up to 17 months. During this time, the investigators will monitor their nasal mucosal antibodies at regular intervals and compare them to their infectious viral load if they are infected with SARS-CoV-2, influenza virus or RSV. Participants are invited to take a test for SARS-CoV-2, influenza virus or RSV in case of respiratory symptoms. If participants are positive the investigators will follow their viral load kinetics by taking nasopharyngeal swabs every 2-3 days. The investigators will also record the duration and strength of the following symptoms: - Cough - Fever - Tired - Sore throat - Difficulty breathing - Respiratory distress - Headache - Loss (or alteration) of smell - Loss (or alteration) of sense of taste - Myalgias - Chills - Subjective fever - Pink sputum (or coughing up blood) - Thoracic pain - Runny nose - Abdominal pain - Nausea - Vomiting - Diarrhea - Constipation - Irritated or watery eyes - Rashes - Other

NCT ID: NCT05780437 Active, not recruiting - COVID-19 Clinical Trials

AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Start date: February 5, 2021
Phase: Phase 3
Study type: Interventional

This study looks at the safety and effectiveness of AZD7442 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a AZD7442 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H4.

NCT ID: NCT05780242 Active, not recruiting - COVID-19 Clinical Trials

Recrudescence of Eating Conduct Disorders and Covid-19

TCA-Covid19
Start date: July 12, 2022
Phase:
Study type: Observational

This qualitative study, combining psychiatric and anthropological perspectives, focused on the development and/or worsening of patients' eating disorders since Covid-19, as well as the experiences and perceptions of those around them - such as their family, teachers or staff. School and nursing staff. This multi-site approach will provide a multidimensional perspective on the experience of individuals and those around them, as well as a triangulation of data. The hypotheses to explain the increase in Eating Disorders (EDs) will be addressed through semi-structured interviews offered to study participants.

NCT ID: NCT05770505 Active, not recruiting - COVID-19 Clinical Trials

Use of E-health Based Exercise Intervention After COVID-19

Start date: April 17, 2023
Phase: N/A
Study type: Interventional

Reduced subjective and objective functional capacity performance are reported after COVID-19 in a large proportion of subjects. The aim of this study is to examine the feasibility and effect of using an e-health tool for guidance and tracking of exercise training in a general population of adults previously infected by COVID-19.

NCT ID: NCT05770180 Active, not recruiting - COVID-19 Clinical Trials

Phase II Clinical Trial of Recombinant COVID-19 Variant Vaccine (Sf9 Cell)

Start date: March 30, 2023
Phase: Phase 2
Study type: Interventional

A single-center, randomized, double-blind, controlled clinical trial to evaluate the safety and immunogenicity of booster vaccination of Recombinant COVID-19 variant vaccine (Sf9 cell) in healthy people aged 18 years and older after completing 2 or 3 doses of novel coronavirus inactivated vaccine (Vero cells)

NCT ID: NCT05769803 Active, not recruiting - Clinical trials for Sars-CoV-2 Infection

Viral Load Analysis of the SARS-CoV-2 Virus in Nose Versus Mouth Sites

Start date: March 14, 2022
Phase: N/A
Study type: Interventional

It is a single-center, non-profit experimental study, intended to evaluate the viral load of SARS COV 2 in nasal and oral samples of positive subjects to evaluate any variation and understand which is the most suitable site for carrying out the swab.

NCT ID: NCT05765773 Active, not recruiting - COVID-19 Clinical Trials

An Open Comparative Study of the Effectiveness and Incomparable Study of the Immunogenicity and Safety of the Vaccine (CoviVac) for Adults Aged 60 Years and Older

Start date: July 1, 2021
Phase: Phase 2
Study type: Interventional

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

NCT ID: NCT05765604 Active, not recruiting - COVID-19 Clinical Trials

Phase I Clinical Trial of Recombinant COVID-19 Variant Vaccine (Sf9 Cell) (WSK-V102)

Start date: March 14, 2023
Phase: Phase 1
Study type: Interventional

Subjects aged 18 and above who have been completed primary or booster vaccination of COVID-19 inactivated vaccines for 3 months or more, to conduct a randomized, parallel controlled, double-blind, single-center phase I clinical trial of Recombinant variant COVID-19 vaccine (Sf9 cell)(WSK-V102) to evaluate the safety, tolerance and immunogenicity of this vaccine in the study population.

NCT ID: NCT05765578 Active, not recruiting - COVID-19 Clinical Trials

An Observational Study of Moderna COVID-19 Bivalent Vaccines (Original and Omicron BA.4/BA.5) and 2023 Updated mRNA COVID-19 Vaccines (XBB.1.5)

Start date: March 8, 2023
Phase:
Study type: Observational

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).