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Covid19 clinical trials

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NCT ID: NCT04583306 Recruiting - Covid19 Clinical Trials

The Salivary Raman COVID-19 Fingerprint

Start date: June 1, 2020
Phase:
Study type: Observational [Patient Registry]

The outbreak of coronavirus disease 2019 (COVID-19), caused by infection of SARS-CoV-2, has rapidly spread to become a worldwide pandemic. Global research focused on the understanding of the biochemical infective mechanism and on the discovery of a fast, sensitive and cheap diagnostic tool, able to discriminate the current and past SARS-CoV-2 infections from a minimal invasive biofluid. The fast diagnosis of COVID-19 is fundamental in order to limit and isolate the positive cases, decreasing with a prompt intervention the infection spreading. The aim of the project is to characterize and validate the salivary Raman fingerprint of COVID-19, understanding the principal biomolecules involved in the differences between the three experimental groups: 1) healthy subjects, 2) COVID-19 patients and 3) subjects with a past infection by COVID-19. The large amount of Raman data will be used to create a salivary Raman database, associating each data with the relative clinical data collected. Starting from the preliminary results and protocols of the Laboratory of Nanomedicine and Clinical Biophotonics (LABION) - IRCCS Fondazione Don Gnocchi Milano, the saliva collected from each experimental group will be analysed using Raman spectroscopy. All the data will be processed for the baseline, shift and normalization in order to homogenize the signals collected and creating in this way the Raman database. The average spectrum calculated from each group will be characterized, identifying the principal families of biological molecules responsible for the spectral differences. EXPECTED RESULTS: Verify the possibility to use Raman spectroscopy on saliva samples for the identification of subjects affected by COVID-19. The principal aim of the project is to create a classification model able to: discriminate COVID-19 current and past infection, identify the principal biological molecules altered in saliva during the infection, predict the clinical course of newly diagnosed COVID-19 patients, translation and application of the classification model to a portable Raman for the test of a point of care.

NCT ID: NCT04583228 Completed - COVID 19 Clinical Trials

Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of HLX71 (Recombinant Human Angiotensin-converting Enzyme 2-Fc Fusion Protein for COVID-19) in Healthy Adult Subjects

Start date: April 8, 2021
Phase: Phase 1
Study type: Interventional

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of HLX71 in Healthy Adult Subjects

NCT ID: NCT04583189 Completed - Covid19 Clinical Trials

Evaluation of the Performance of the Covid-19 Ag BSS Rapid Antigenic Test in Symptomatic Children in a Pediatric Emergency Department

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

This study compares the diagnostic performance of a nasopharyngeal swab antigenic test versus the RT-PCR Covid-19 reference test performed with the AllplexTM 2019-nCoV kit (Seegene, South Korea) in symptomatic children presenting at the hospital.

NCT ID: NCT04582903 Recruiting - COVID-19 Infection Clinical Trials

Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute COVID-19 and Convalescence

Start date: October 13, 2020
Phase:
Study type: Observational

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19). The global outbreak of COVID-19 is a major public health problem. COVID-19 causes a wide range of symptoms. These symptoms range from mild breathing problems to life-threatening problems or death. Some people have no symptoms. This study aims to learn how acute and late immune responses to COVID-19 lead to different outcomes. The immune system is the body s defense against germs, including viruses, that invade the body. Objective: To characterize the immune responses during and after SARS-CoV-2 infection and determine if there is any relationship to clinical course and outcome. Eligibility: People ages 0 99 who have confirmed or suspected SARS-CoV-2 infection, people who are not infected despite heavy exposure, and relatives of enrolled participants. Design: This is a sample collection protocol to receive send-in biological specimens for exploratory studies, including gene testing. Participants will not be seen at the NIH for study visits. Study staff will talk with participants health care providers to screen them for the study. Participants enrolled into the protocol will send samples and clinical information at least once and more often if the participant has COVID-19. All participants will provide blood samples and possibly stool. We may also ask for left over specimens from any medical procedures completed as part of medical care. The study staff will also request participants health care providers to complete a survey to collect demographic and medical data. Some of this information may need to be provided directly by the participant. Pregnant individuals are invited to participate and may be asked to give cord blood samples after delivery. Study findings that affect participants health may be shared with their health care provider. Depending on findings, participants may be contacted to take part in other NIH studies.

NCT ID: NCT04582344 Completed - COVID-19 Clinical Trials

Clinical Trial For SARS-CoV-2 Vaccine (COVID-19)

Start date: September 14, 2020
Phase: Phase 3
Study type: Interventional

This study is a randomized, double-blinded, and placebo controlled phase III clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the experimental vaccine in healthy adults aged 18~59 Years.

NCT ID: NCT04582331 Completed - Covid19 Clinical Trials

Improving Real-time COVID-19 Monitoring Through Smartphone Voice Analysis

Start date: September 10, 2020
Phase:
Study type: Observational

This is a confirmatory study that seeks to examine whether respiratory-responsive vocal biomarkers have potential to respond to COVID-19 infection status and respiratory symptom severity. Patients with suspected COVID-19 and healthy controls will submit daily voice samples and symptom inventories on their personal smartphone devices for 14 days.

NCT ID: NCT04582318 Terminated - Clinical trials for SARS-CoV-2 Infection

A Phase 1/2 Study to Assess the Safety, Tolerability and Pharmacokinetics of NGM621 in Healthy Subjects, and to Assess the Safety, PK and Efficacy in Subjects With Moderate to Severe ARDS Caused by COVID-19

Start date: November 9, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a combined Phase 1 and Phase 2 study with IV infusion of NGM621 to evaluate the safety, tolerability, and PK in healthy volunteers (Part 1), and safety, tolerability, PK and efficacy in subjects with confirmed SARS-CoV-2 infection (Part 2).

NCT ID: NCT04582266 Completed - COVID-19 Clinical Trials

PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US

Start date: March 31, 2021
Phase:
Study type: Observational

IMPAACT 2032 was a Phase IV prospective, open label, non-randomized opportunistic study. The objectives of this study were to describe the pharmacokinetic (PK) properties and safety of remdesivir (RDV) administered intravenously as part of clinical care among hospitalized pregnant and non-pregnant women of childbearing potential with coronavirus disease of 2019 (COVID-19). RDV was provided and managed by the participant's treating physician and was not provided as part of this study.

NCT ID: NCT04582214 Recruiting - COVID-19 Clinical Trials

Oscillation and Lung Expansion Therapy in Patients With COVID-19

Start date: September 28, 2020
Phase: N/A
Study type: Interventional

A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized with COVID-19

NCT ID: NCT04581954 Recruiting - Covid19 Clinical Trials

Inflammatory Signal Inhibitors for COVID-19 (MATIS)

MATIS
Start date: October 2, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The Multi-arm trial of Inflammatory Signal Inhibitors for COVID-19 (MATIS) study is a two-stage, open-label, randomised controlled trial assessing the efficacy of ruxolitinib (RUX) and fostamatinib (FOS) individually, compared to standard of care in the treatment of COVID-19 pneumonia. The primary outcome is the proportion of hospitalised patients progressing from mild or moderate to severe COVID-19 pneumonia. Patients are treated for 14 days and will receive follow-up assessment at 7, 14 and 28 days after the first study dose. Patients with mild or moderate COVID-19 pneumonia will be recruited. Initially, n=171 (57 per arm) patients will be recruited in Stage 1. Following interim analysis to assess the efficacy and safety of the treatments, approximately n=285 (95 per arm) will be recruited during Stage 2.