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119 active trials for SARS-CoV Infection

A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ? 18 Years With a Pediatric Expansion in Adolescents (12-17 Years) at Risk for SARS-CoV-2

This is a study to evaluate the effectiveness, immune response, and safety of a coronavirus disease 2019 (COVID-19) vaccine called SARS-CoV-2 rS with Matrix-M1 adjuvant in adults 18 years of age and older with a pediatric expansion in adolescents (12 to 17 years) in the United States and Mexico. A vaccine causes the body to have an immune response that may help prevent the infection or reduce the severity of symptoms. An adjuvant is something that can make a vaccine work better. This study will look at the protective effect, body's immune response, and safety of SARS-CoV-2 rS with Matrix-M1 adjuvant in the study population. Participants in the study will randomly be assigned to receive SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo. Each participant in the study will receive a total of 2 intramuscular injections of either ARS-CoV-2 rS with Matrix-M1 adjuvant or placebo in the Initial Vaccination Period. Up to 33,000 participants will take part in the study. Following the recommendation of COVID-19 vaccination for all adults 18 years of age and older, adult participants will be scheduled for the administration of 2 injections of the alternate study material 21 days apart ("blinded crossover"). That is, initial recipients of placebo will receive SARS-CoV-2 rS with Matrix-M1 adjuvant and initial recipients of SARS-CoV-2 rS with Matrix-M1 adjuvant will receive placebo. A blinded crossover will be implemented for adolescents 12-17 years of age approximately 6 months after the initial vaccination.

Start: December 2020

Long Term Efficacy and Safety of COVID-19 (SARS-CoV-2) Vaccination in Kidney Disease Patients

Rationale: COVID-19 is associated with severely increased morbidity and mortality in patients with chronic kidney disease stage G4-G5 and patients on dialysis or after kidney transplantation. Therefore, effective SARS-CoV-2 vaccination would be of great clinical importance in these patients. However, SARS-CoV-2 vaccination studies have excluded these patients so-far. Literature data indicate that vaccination may be less effective in these patient groups. Objective: To assess the efficacy and safety of SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, patients on dialysis or after kidney transplantation during two years follow-up after vaccination. Study design: prospective single center observational cohort study. Study population: all Dutch patients on dialysis with data registered in the Dutch Dialysis registry (RENINE) all Dutch patients after kidney transplantation with data registered in the Dutch national kidney transplant registry (NOTR). All Dutch patients with chronic kidney disease stage G4-G5 registered in the Santeon hospitals. Intervention: After SARS-CoV-2 vaccination according to standard of care, blood will be drawn for antibody response measurements at day 28 and month 6 after 2nd vaccination at by mailer-based finger-prick in 3400 hemodialysis patients, 600 peritoneal dialysis patients, 4000 patients after kidney transplantation and 4000 patients with chronic kidney disease stage G4-G5 Main study parameters/endpoints: The primary endpoint is efficacy of SARS-CoV-2 vaccination determined as: - the incidence of COVID-19 after vaccination. Secondary endpoints are the antibody based immune response at 28 days after completion of vaccination. the duration of antibody based immune response at 6 months compared to at 28 days after completion of vaccination. mortality adverse events of specific interest according to (inter)national authorities in collaboration with LAREB presence of HLA-antibodies in dialysis patients on the waiting list for a first kidney transplantation acute rejection and graft failure in patients after kidney transplantation The incidence of these endpoints will be compared, if applicable, to those: in the general population who are vaccinated in patients on dialysis or after kidney transplant who are not vaccinated Within these patient groups endpoints will be compared between recipients of different vaccines.

Start: April 2021

Immunogenicity, Efficacy and Safety of QazCovid-in® COVID-19 Vaccine

Multicenter, randomized, blind, placebo-controlled clinical study of III phases on the assessment of preventive efficiency, safety and immunogenicity QazCovid-in®-vaccine against COVID-19 in healthy adult volunteers

Start: December 2020

SARS-CoV-2 Human Challenge Characterisation Study

This is a dose optimisation study in healthy adults aged 18-30 who will be experimentally inoculated with SARS-CoV-2. The aim is to cause PCR-confirmed upper respiratory infection in the majority of challenged individuals with minimal or no illness, providing data on the course of COVID-19 and the immune response to SARS-CoV-2 infection. This will establish an optimised dose and study design that will then be used to evaluate the efficacy of treatment and vaccine candidates plus level and duration of immune protection in follow-on trials.

Start: March 2021

Policy Responses Against the COVID-19 Pandemic in Latin America

Latin America is one of the worst-hit areas from the COVID-19 pandemic worldwide. Policy responses to COVID-19 in Latin America have sought to reduce viral spread, increase the capacity of the health system response, mitigate negative consequences, and strengthen governance. Few studies have examined the effectiveness of COVID-19 policies in Latin America or explored subnational variation in their effectiveness. In this observational study, the investigators will use a two-stage interrupted time series to estimate the effectiveness of nonpharmaceutical interventions in third-tier subnational units on SARS-COV2 transmission and COVID-19 mortality in Latin America. The investigators will estimate the effects in each local government, and then run a random-effects meta-analysis to obtain pooled effects for each intervention (and combinations of) and heterogeneity estimates. Finally, the investigators will explore potential explanations for the heterogeneity at the local level.

Start: April 2021

Glenzocimab in SARS-Cov-2 Acute Respiratory DistrEss syNdrome Related to COVID-19

A randomized, double blind, multicenter, placebo-controlled, parallel group, fixed dose, phase II study to evaluate the efficacy and safety of glenzocimab in ARDS.

Start: December 2020

Efficacy and Safety of Ozonised Oil (HOO) in COVID-19 Patients

The anti-viral efficacy of ozone against RNA viruses is already established. Ozone gas have been already proposed as possible therapy for Covid-19 infection with insofar limited success. The development of ozonized oil (HOO) solved this problems making ozone highly stable and bioavailable due to its bound with the lipid carrier. HOO administration is totally noninvasive occurring by oral administration of pills or as nasal spray. HOO regimen could be proposed as complimentary therapeutic treatment for Covid-19 infection, without the need of any modifications of the established standard therapeutic protocols. This complimentary treatment, could be helpful to (a) decrease the severity of the diseases lowering the number of Covid-19 patients requiring high-intensity therapies; (b) fasten qPCR negativization after disease and time-span of hospital recovery. The objective of this study is to investigates the effectiveness of combined use of "HOO capsules" and "HOO oropharyngeal and nasal spray" as a therapeutic supplement in the treatment of patients with confirmed COVID-19, who are moderately ill.

Start: July 2021

Proxalutamide Treatment for COVID-19 Female Outpatients

This study is intended to explore the possible protective role of anti-androgens in SARS-CoV-2 infection

Start: November 2020

Longitudinal Follow-up of Patients With Chronic Inflammatory Rheumatisms (CIRs) Vaccinated Against COVID-19 Compared to Patients Refusing Vaccination

To date, studies on SARS-CoV2and vaccines have been mostly from the general population not exposed to immunosuppressants. The efficacy and safety of COVID-19 vaccines need to be evaluated in these populations.

Start: April 2021

Oral Manifestation in Patients With SARS-CoV2 Infection.

The oral cavity is particularly susceptible to viral infection with several viruses such as herpes simplex virus, cytomegalovirus and Zika virus because of its structures, especially salivary glands and soft tissues Moreover, oral mucosa can be affected by secondary pathological process of a bacterial or fungal nature due to viral immunosuppression. The oral cavity could be considered a "biological barometer" of both viral infection and viral immunosuppression advancement .

Start: April 2021

Diode Laser 940 nm in Management of Loss of Taste Sensation

The global pandemic has recently emerged by transmission of SARS-CoV2 virus. The virus has had a massive impact on health, wealth and social aspects worldwide. Since the identification of this virus in Wuhan, China, millions of cases has been diagnosed worldwide with mortality rates ranging from 3% to 12 %

Start: April 2021

Brazilian Registry for Clinical Presentation of Individuals With COVID-19 (SARS-Brazil)

This is a registry-based cohort study of all adult patients (?18 years) with confirmed or suspected SARS-CoV-2 infection. The main goal is to describe mortality incidence, demographic characteristics, coexisting conditions, treatments, outcomes among SARS-CoV2 infected patients. A secondary goal is to identify biological factors (OMICS - genomic, proteomic and metabolomics characterization) associated with severity conditions for these patients.

Start: July 2020

COVID-19 Induced Telogen Effluvium

This study inquires about the development of Telogen effluvium following the SARS-CoV-2 infection

Start: January 2021

SARS-CoV-2 Infection Among Health Care Workers

The present study finds opportunities and justifications, taking into consideration that the nature of professional practice in health needs scientific evidence resulting from systematic and systemic studies to strengthen the basis for the decisions made to have an impact on various levels, from the patient to health management itself. In addition, Cabo Verdean authorities may benefit from new evidence obtained by this study. It intends, in a growing number of health professionals exposed or infected with SARS-CoV-2, involved at the front line, in the different health structures of the country, to contribute to substantiate a better perception of the problem and the required solutions. Therefore, assessing the potential risk factors for SARS-CoV-2 infection among healthcare workers will be essential to characterize virus transmission, preventing future infections in them and providing the associated healthcare. Due to the advances and important changes described, questions arise that guide this research and allow us to identify the problem.

Start: April 2021

MIcrovascular Dysfunction in CRitically Ill cOVID-19 Patients

Microcirculatory dysfunction appears to play a key role in the development of organ failure leading to the death of patients with coronavirus disease 2019 (Covid-19). It is still uncertain today whether this damage is secondary to direct viral infection of endothelial cells or the consequence of the inappropriate inflammatory response induced by the infection. The analysis of endothelial and microcirculatory dysfunctions and glycocalyx degradation therefore appears to be necessary in the understanding of the pathophysiological mechanisms of Covid sepsis and could play a role in the evaluation of the efficacy of certain therapeutics which would aim at improving regional perfusion by decreasing microcirculatory dysfunction.However, the analysis of microcirculatory failure, endothelial dysfunction and glycocalyx degradation has so far only been evaluated in small cohorts, without quantitative analysis of microcirculatory perfusion

Start: March 2021

Study of HEarT DiseAse and ImmuNiTy After COVID-19 in Ireland

SETANTA study will investigate the incidence of cardiac abnormalities as assessed by cardiac magnetic resonance imaging in unselected patients after acute SARS-CoV-2 infection and correlation with immunological response and biomarkers of coagulation.

Start: February 2021

Michigan Medicine COVID-19 Cohort: Clinical Characteristics, Inflammatory Markers and Outcomes of Patients Hospitalized for COVID-19

To better understand the role of inflammation in COVID-19, we established the Michigan Medicine COVID-19 Cohort (M2C2). M2C2 is a funded and ongoing cohort which has currently enrolled over 1500 adult patients (?18 years) with severe COVID-19 admitted at the University of Michigan. The purpose of M2C2 is to define the in-hospital course of these patients and understand the role of inflammation as a determinant of organ injury and outcomes in COVID-19.

Start: March 2020

Safety and Immunogenicity of an Intranasal SARS-CoV-2 Vaccine (BBV154) for COVID-19

The study is designed to evaluate the safety, reactogenicity, and immunogenicity of three groups of healthy volunteers who receive either intranasal single dose (Vaccine on Day 0 and placebo on Day 28) or two-dose (vaccine on Day 0 and 28) of BBV154 vaccine or Placebo (on Day 0 and day 28). A total of 175 subjects will be enrolled in 2:2:1 ratio and will be conducted in a double-blinded manner. To assess the safety of the vaccine, each participant will record symptoms in a diary card for 7 days after each dose. Safety and laboratory tests and physical exams will also be performed. Blood samples and saliva samples be collected to assess the immune response from the vaccine. An interim report based on the safety and immunogenicity of the vaccine (BBV154) will be notified to the Central Drugs Standard Control Organization (CDSCO), India, for further progressing the clinical development of the vaccine. This unblinded interim report will contain a detailed analysis of the data based on the primary and secondary objectives of all visits through Day 42 (Immunogenicity & Safety).

Start: March 2021

A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults

This is a Phase 2, randomized, placebo-controlled, and observer-blind study in healthy adults. The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19: As 2 doses (at two different dose levels), separated by 28 days or as 1 dose In adults 18 years of age and older

Start: January 2021

Influence of Military Preventive Policy for reCruit Training on COVID-19 Seroconversion

This study is intended to address the association between vitamin D status and seroconversion to SARS-CoV-2 in healthy young adults. The primary aim of the study is to determine the rates of 'silent' seroconversion rates, consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population with a wide spread of vitamin D concentrations. The secondary aims of this study are to explore: Any effect of vitamin D status on symptomatic illness. The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults. The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time. Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/ complementary serological method The effect (if any) of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs and iii) gender.

Start: September 2020