View clinical trials related to SARS-CoV-2 Infection.
Filter by:Evidence of COVID-19 related anosmia and dysgeusia continues to accumulate daily. Currently, up to 80% of patients report subjective olfactory dysfunction (OD), and prevalence using objective olfactory testing could be even higher. We propose a phase II single-site, double-blinded, placebo-controlled randomized clinical trial to determine the efficacy and safety of intranasal theophylline, a known phosphodiesterase inhibitor in the treatment of asthma, as a possible treatment for COVID-19 related OD. Theophylline has shown benefit in similar clinical trials for post-viral OD.
BACKGROUND: On January 7, 2020, the Chinese authorities identified as the agent responsible for the cases of atypical pneumonia of unknown etiology a new type of virus of the Coronaviridae family that has subsequently been named SARS-CoV-2, whose genetic sequence was shared by Chinese authorities on January 12 (taxonomy ID: 2697049). On January 30, 2020, the director general of the World Health Organization (WHO), following the advice of the Emergency Committee convened in accordance with the International Health Regulations (2005), declared that the COVID-19 outbreak started in Wuhan, China in December 2019, being a public health emergency of international concern. On March 11, the WHO declared the global SARS-CoV-2 pandemic. So far, in the absence of effective vaccines or antiviral drugs, efforts have focused on identifying cases and their contacts. Both the cases and their contacts are isolated for about 14 days with the intention of minimizing the spread of this infection and avoiding an increase in the number of affected. At the time of writing this new version of the protocol, we are immersed in the second wave of the COVID-19 pandemic. The projections of the natural history of the disease and the estimates of possible infections by SARS-CoV-2, carried out at the end of the first wave, made it possible to determine the feasibility of this second wave with the onset of cold from the autumn. Given this scenario, the University of Barcelona, together with the Gerencia Territorial del Área Metropolitana Sud, has planned to carry out, a study of seroprevalence and screnning of SARS-CoV-2 in the population of Universidad de Barcelona users. The results of this study will help to make preventive decisions in the face of SARS-CoV-2 infection at the UB, in relation to its teaching and administrative activities. In addition, this cross-sectional study can serve as the base study for a future follow-up study. HYPOTHESIS: The incidence of SARS-CoV-2 infection in the group of students and workers at the University of Barcelona is similar to the incidence in the general population. MAIN OBJECTIVE: - Estimate the incidence of SARS-CoV-2 infection in the UB community. - Estimate the SARS-CoV-2 seroprevalence infection in the UB community.
Double-blind, parallel, randomized, placebo-controlled clinical study. Subjects with confirmed SARS-CoV-2 infection by PCR or antigen rapid test, asymptomatic or with mild COVID-19 symptoms will be included. Subjects who agree to participate and who are eligible will be randomized to perform a mouth rinse and gargle with a 0.07% CPC mouthwash (experimental) or with a substance of the same color (placebo). Saliva samples will be collected at baseline (i.e., before wash) and 1 hour and 3 hours after wash. Saliva samples will be transferred to a central laboratory for SARS-CoV-2 viral load determination, nucleocapsid protein levels determination, rapid antigen testing, viral infectivity analysis and storage.
Results will be submitted, however please note that data are not yet available for all serology outcome measures. This will be a Phase 2/3, randomized, placebo-controlled, observer-blind study evaluating the safety, tolerability, and immunogenicity of 30 µg of BNT162b2 or placebo administered in 2 doses, 21 days apart, in approximately 350 healthy pregnant women 18 years of age or older vaccinated at 24 to 34 weeks' gestation. Participants will be randomized 1:1 to receive BNT162b2 or placebo (saline).
This study is an open-label trial in which hospitalized patients with risk factors of severe coronavirus disease 2019 [COVID-19] will be receive treatment with convalescent plasma (≤ 15 days from symptoms start).
Assessment of the seroprevalence and sero-incidence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) among Nursing Home (NH) residents and staff in Belgium.
The current study aimed to make a therapeutic comparison and effectiveness of Hydroxychloroquine (HCQ) and Montelukast (ML) in COVID-19 patients in addition to the standard of care. The safety and efficacy of HCQ and ML will be assessed as individual therapy and in combination with each other and with the standard of care. Cytokine storm (Interleukin levels) also will be monitored throughout the study to assess treatment progression.
This is a Phase 3, randomized, observer-blind study in healthy individuals. The primary study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate (BNT162b2): - As a 30-microgram dose, administered from 1 of 4 manufacturing lots (batches) - As a 20-microgram dose, administered from 1 of the manufacturing lots - As a 2-dose (separated by 21 days) schedule - In people 12 through 50 years of age The booster study will evaluate the safety, tolerability, and immunogenicity of 2 SARS-CoV-2 RNA vaccine candidates (BNT162b2 and BNT162b2.B.1.351): - Each as a 30-microgram dose - Each as a 1-dose booster vaccine, administered approximately 3 months after Dose 2 - In people 18 through 50 years of age
Olfactory dysfunction is a defining symptom of COVID-19 infection. As the number of total, confirmed COVID-19 cases approached 19 million in the United States, it is estimated that there will be 250,000 to 500,000 new cases of chronically diminished smell (hyposmia) and loss of smell (anosmia) this year. Olfactory dysfunction is proposed to worsen numerous common co-morbidities in patients and has been shown to lead to a decreased quality of life. There are very few effective treatments for hyposmia or anosmia, and there is no gold standard of treatment. One proposed treatment option is smell training, which has shown promising yet variable results in a multitude of studies. It garners its theoretical basis from the high degree of neuroplasticity within the olfactory system, both peripherally and centrally. However, due to a relative inadequacy of proper studies on olfactory training, it is unknown what the most efficacious method in which to undergo the training is. This study proposes two novel procedural modifications to smell training in an attempt to enhance its efficacy. The investigators propose using a bimodal visual-olfactory approach, rather than relying on olfaction alone, during smell training, as well as using patient-preferred scents in the training that are identified as important by the study participant, rather than pre-determined scents with inadequate scientific backing. The investigators hypothesize that by utilizing bimodal visual-olfactory training and patient-selected scents, the olfactory training will be more efficacious and more motivating for participants.
This study is a 4-arm, multicenter, randomized, partly double- blind, controlled trial to evaluate the safety and efficacy of convalescent serum (CP) or camostat mesylate with control or placebo in adult patients diagnosed with SARS-CoV-2 and high risk for moderate/severe COVID-19. The working hypothesis to be tested in the RES-Q-HR study is that the early use of convalescent plasma (CP) or camostat mesylate (Foipan®) reduces the likelihood of disease progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of moderate or severe COVID-19 progression. The primary endpoint of the study is the cumulative number of individuals who progressed to or beyond category 4b on the modified WHO (World Health Organization) COVID-19 ordinal scale within 28 days after randomization.