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Covid19 clinical trials

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NCT ID: NCT04643691 Recruiting - COVID-19 Clinical Trials

Losartan and Spironolactone Treatment for ICU Patients With COVID-19 Suffering From ARDS

COVIDANCE
Start date: September 11, 2020
Phase: Phase 2
Study type: Interventional

Coronavirus disease (COVID-19) is a current pandemic infection caused by an RNA virus called Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). Severe forms of COVID-19 are most often responsible for isolated respiratory failure in the form of acute respiratory distress syndrome (ARDS), which accounts for most of the mortality. Angiotensin converting enzyme 2 (ACE2) has been shown to be a co-receptor for the entry of SARS-CoV-2 into cells and is likely to play a prolonged role in the pathogenesis of COVID-19. ACE2 and angiotensin (1-7) have been shown to be protective in a number of different lung lesion models. In a mouse model of acidic lung injury, negative regulation of ACE2 by COVID, the SARS virus responsible for the 2003 SARS outbreak, worsened the lung injury which was improved by treatment with ARBs. We believe that blocking the first RAS pathway at the end of the chain on the AT1r angiotensin 2 receptor may prevent the initiation of this chain reaction and limit decompensation secondary to the disruption of the equilibrium of the renin-angiotensin system. We have several molecules that block the AT1r angiotensin-2 receptor (ARBs) as well as a molecule that blocks the secretion of aldosterone (spironolactone). The main objective is to demonstrate the value of losartan and spironolactone therapy in the regulation of the renin-angiotensin system in improving the prognosis of patients infected with COVID-19 and suffering from acute respiratory distress syndrome. This is a prospective, multicenter, randomized, open-label, controlled, therapeutic trial studying two parallel groups. The population included in this study is any major patient in acute respiratory distress hospitalized in intensive care requiring oxygen support of at least 6L/min and suffering from a PCR-confirmed SARS-cov2 infection. The control group will benefit from the usual resuscitation management of COVID19 , and the experimental group will benefit from losartan and spironolactone treatment in addition to the usual management, according to the study protocol. The number of subjects required has been calculated and 45 patients for each group, for a total of 90 patients. The SOFA score at D7 will be compared between the "experimental" versus "control" groups using a mean comparison method. The comparison of this criterion and all secondary criteria of judgments between the 2 groups will be performed using a Student or Mann-Whitney test based on the normality of the distribution. The significance threshold will be set at 0.05. No intermediate analysis is scheduled. The analysis will be blinded. The main expected outcome is an improved prognosis with a decrease in the SOFA severity score at 7 days in resuscitation patients, resulting in an improvement in organ failure. The expected secondary results will be to show the interest of ARA2/Spironolactone treatment on oxygenation based on the PaO2/FiO2 ratio, mechanical ventilation duration and mortality.

NCT ID: NCT04642703 Recruiting - Covid19 Clinical Trials

Mortality in Patients With Severe COVID-19 Pneumonia Who Underwent Tracheostomy

Start date: March 3, 2020
Phase:
Study type: Observational

Background: Invasive mechanical ventilation (IMV) in COVID-19 patients has been associated with a high mortality rate. In this context, the utility of tracheostomy has been questioned in this group of ill patients. This study aims to compare in-hospital mortality in COVID-19 patients with and without tracheostomy due to prolonged IMV Methods: Cohort study of adult COVID-19 patients subjected to prolonged IMV. Since the first COVID-19 case (March 3, 2020) up to November 30, 2020, all adult critical patients supported with IMV by 10 days or more at the Hospital Clínico Universidad de Chile will be included in the cohort. Pregnant women and non-adult patients will be excluded. Baseline characteristics, comorbidities, laboratory data, disease severity, and ventilatory support will be retrospectively collected from clinical records. The indication of tracheostomy, as part of our standard of care, will be indicated by a team of specialists in intensive care medicine, following national guidelines, and consented to by the patient's family. The 90-days mortality rate will be the primary outcome, whereas IMV days, hospital/CU length of stay, and the frequency of healthcare-associated infections will be the secondary outcomes. Also, a follow-up interview will be performed one year after a hospital discharged in order to assess the vital status and quality of life. The mortality of patients subjected to tracheostomy will be compared with the group of patients without tracheostomy by logistic regression models. Furthermore, propensity-score methods will be performed as a complementary analysis.

NCT ID: NCT04642040 Recruiting - Covid19 Clinical Trials

Effectiveness of Pulmonary Rehabilitation Program in Patients With SARS-CoV-2 Pneumonia

Start date: June 30, 2020
Phase: N/A
Study type: Interventional

The aim of the study is to investigate the efficacy of pulmonary rehabilitation (PR) program to patients with Sars-CoV-2 pneumonia in the post-acute period on pulmonary functions, exercise capacity and anxiety level. 100 patients diagnosed with Sars-CoV-2 pneumonia will be enrolled in this prospective, interventional study according to inclusion/exclusion criteria. Patients will be evaluated and a personalized PR program will be organized before hospital discharge. After discharge, the pulmonary rehabilitation program will continue in telerehabilitation. In the telerehabilitation program, exercises will be supervised by a physiotherapist two days a week, and patients will be asked to do the exercises themselves for the other 3 days. Patients will also receive exercise videos for these 3 days. Patients will be followed for 4 weeks and will be called for final evaluation

NCT ID: NCT04640428 Recruiting - Covid19 Clinical Trials

COVID-19 Stroke Apical Lung Examination Study

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

Multi-centre prospective study evaluating computed tomography angiography studies performed for stroke patients as a diagnostic and prognostic imaging biomarker.

NCT ID: NCT04639427 Recruiting - Covid19 Clinical Trials

Benefits of Using a Transparent Visor to Replace the Face Mask in Speech Therapy Rehabilitation of Oral-Linguo-Facial Praxies in the Context of COVID-19: a Series of Cases

Co-VIS
Start date: February 8, 2021
Phase:
Study type: Observational

The primary objective of the study is to compare the effectiveness of the use of a transparent covering visor with that of the face mask, with or without the use of video sequences, for speech therapy rehabilitation of oral-linguo-facial praxies in the context of the COVID 19 epidemic.

NCT ID: NCT04637906 Recruiting - Covid19 Clinical Trials

Short and Long-term Effects of Adding Oral L-arginine to Standard Therapy in Patients With COVID-19 (SARS-CoV-2)

Start date: November 18, 2020
Phase: N/A
Study type: Interventional

Single-center study with a parallel group scheme, double-blind, randomized, placebo-controlled, to evaluate whether the addition to the investigator's hospital standard therapy of two vials of Bioarginina® per day in subjects with SARS-CoV-2 is useful for treatment of this pathology.

NCT ID: NCT04637828 Recruiting - COVID-19 Clinical Trials

A Study to Compare the Efficacy of GNS561 Versus Standard of Care in Patients With SARS-CoV-2 (COVID-19) Infection

CureCovid-2019
Start date: November 18, 2020
Phase: Phase 2
Study type: Interventional

This is a multicenter, open-label, controlled, randomized phase 2 study designed to evaluate the safety and efficacy profile of GNS561 in patients with COVID-19.

NCT ID: NCT04636333 Recruiting - COVID-19 Clinical Trials

Phase I Trial of a Recombinant COVID-19 Vaccine (CHO Cell)

Start date: October 30, 2020
Phase: Phase 1
Study type: Interventional

This is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 18 years and older. After randomization, the trial for each subject will last for approximately 13 months. Screening period is 1 week prior to randomization (Day -7 to Day -1), and each dose of either SARS-CoV-2 vaccine (CHO Cell) or placebo will be given intramuscularly (IM) on Day 0 and Day 14 for a two-dose regimen, or on Day 0, Day 14, and Day 28 for a three-dose regimen. Subjects who are ≥18 years old and ≤ 59 years old will be enrolled in adult group, and healthy elderly population who are >59 years old will be enrolled in elderly group. After adult group completes the follow-up 7 days after first vaccination, elderly group will be recruited.

NCT ID: NCT04632173 Recruiting - Covid19 Clinical Trials

Head and Neck cancERs International cOviD-19 collabOraTion

Start date: May 3, 2021
Phase:
Study type: Observational

To develop an International registry on head and neck cancer patients infected with COVID-19

NCT ID: NCT04628039 Recruiting - COVID-19 Clinical Trials

Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs

LAUREL
Start date: May 27, 2021
Phase:
Study type: Observational

This is study is comprised of three approaches. First, the investigators will conduct a retrospective cohort study to determine factors associated with COVID-19 severity and complications and understand COVID-19 outcomes, including all-cause mortality, post-discharge events, and impacts of rehabilitation services (third aim). The second aim is a mixed-method study and follows COVID-19 patients with repeated surveys to determine patient-reported functional outcomes, health recovery, and rehabilitation needs after COVID-19. The investigators will recruit patients and their informal caregivers for interviews to assess their function and rehabilitation needs.