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NCT ID: NCT04339712 Completed - COVID-19 Clinical Trials

Personalised Immunotherapy for SARS-CoV-2 (COVID-19) Associated With Organ Dysfunction

ESCAPE
Start date: April 2, 2020
Phase: Phase 2
Study type: Interventional

Our aim is to conduct one trial of personalized immunotherapy in patients with SARS-CoV-2 (COVID-19) associated with organ dysfunction and with laboratory findings of macrophage activation syndrome or immune dysregulation. These patients will be selected by the use of a panel of biomarkers and laboratory findings and they will be allocated to immunotherapy treatment according to their needs.

NCT ID: NCT04338841 Completed - Clinical trials for Coronavirus Infection

HOME-CoV: Hospitalization or Outpatient ManagEment of Patients With a SARS-CoV-2 Infection

HOME-CoV
Start date: April 9, 2020
Phase: N/A
Study type: Interventional

COVID-19 pandemic has developed worldwide in less than 4 months. The clinical presentations are variable widely, ranging from simple rhinitis to major lung damage that can lead to death. In many countries involved in the ongoing health disaster due to SARS-CoV-2 infection, hospital are overloaded. In this context, the decision to hospitalize or to manage COVID-19 patients at home is crucial and defining reliable and consensual criteria is a major issue. HOME-CoV study is a multicentre quasi-experimental interventional study, before and after implementation of a help-decision making rule (HOME-CoV rule), developed via the Delphi method. Our main hypothesis is that a strategy based on the consensual HOME-CoV rule compared to current practice is at least as safe as regards the 7-day-rate of adverse events (safety criterion) and more effective as regards the rate of patients eventually managed as outpatients (efficacy criterion).

NCT ID: NCT04337918 Completed - Clinical trials for Corona Virus Infection

Nitric Oxide Releasing Solutions to Prevent and Treat Mild/Moderate COVID-19 Infection

NOCOVID
Start date: May 8, 2020
Phase: Phase 2
Study type: Interventional

This is a multi-center, randomized, controlled, phase II clinical efficacy study evaluating a novel Nitric Oxide Releasing Solution (NORS) treatment for the prevention and treatment of COVID-19 in healthcare workers at risk of infection. Participants will be enrolled into one of two components of this study. Based on initial swabs/symptoms, volunteers who are COVID-19 negative will be enrolled in the Prevention study and randomized to receive standard institutional precautions or standard institutional precautions + NORS. Those who are COVID-19 positive will be enrolled in the open-label Treatment Sub-Study.

NCT ID: NCT04337541 Completed - COVID-19 Clinical Trials

Reduction in COVID-19 Infection Using Surgical Facial Masks Outside the Healthcare System

Start date: April 2, 2020
Phase: N/A
Study type: Interventional

In the current COVID-19 pandemic with coronavirus, SARS-COV2, the Danish Health Authorities recommend using facial masks in the health care system when handling patients presumed or proven to be infected with the virus. However, the use of facial masks outside the health care system is not recommended by the Danish Health Authorities. Here, Health Authorities in other countries have different recommendations for the use of facial masks. Challenges when using facial masks outside the health care system include wearing the mask consistently, an efficacy of the mask of app. 8 hours necessitating a change of mask throughout the day, and that it is not sufficiently tight enough to safely keep the virus out. Moreover, the eyes (mucous membrane) remain exposed. Compliance could also be another challenge. SARS-COV2 is assumed to primarily enter the body via the mouth through respiratory droplets - or possibly through inhalation of aerosol containing the virus. From the mouth the virus is assumed to spread to the airways and the gastro-intestinal tract. SARS-COV2 is also known to be transmitted via physical contact, helped along by the fact that the virus can survive on surfaces for at least 72 hours. Touching such a contaminated surface can transfer the virus to the mouth via the hand - and thus lead to infection of the person. Facial masks are expected to protect against viral infection in two ways; 1. By reducing the risk of getting the virus in via the mouth or nose via respiratory droplets or aerosol 2. By reducing the transfer from virus-contaminated hands to the mouth or nose Hypothesis The use of surgical facial masks outside the hospital will reduce the frequency of COVID-19 infection. All participants will follow authority recommendations and be randomized to either wear facial masks or not. The participants will be screened for antibodies at study start and study end. They will perform swab-test if they experience symptoms during the study as well as the end of study.

NCT ID: NCT04335552 Terminated - SARS-CoV-2 Clinical Trials

Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection

Start date: April 17, 2020
Phase: Phase 2
Study type: Interventional

This is a pragmatic, randomized, open-label, incomplete factorial with nested randomization clinical trial evaluating the efficacy and safety of two potential treatments for hospitalized patients with confirmed SARS-CoV-2 infection. Participants who are hospitalized and have a positive nucleic acid amplification test for SARS-CoV-2 will undergo an initial randomization in a 1:1 ratio to one of the following regimens: Arm 1: Standard of care alone Arm 2: Standard of care plus hydroxychloroquine Participants who meet eligibility criteria to receive azithromycin will undergo a second randomization in a 1:1 ratio to receive additional concurrent therapy. This will effectively result in four treatment groups: 1. Standard of care alone 2. Standard of care plus hydroxychloroquine 3. Standard of care plus azithromycin 4. Standard of care plus hydroxychloroquine plus azithromycin

NCT ID: NCT04333225 Completed - COVID-19 Clinical Trials

Hydroxychloroquine in the Prevention of COVID-19 Infection in Healthcare Workers

Start date: April 3, 2020
Phase: Phase 2
Study type: Interventional

In order to assess the efficacy of hydroxychloroquine treatment weekly for a total of 7 weeks in the prevention of COVID-19 infection, three hundred sixty (360) Healthcare workers with high risk exposure to patients infected with COVID-19 will be tested for COVID-19 infection via nasopharyngeal (NP) swab once weekly for 7 weeks. Of those, one hundred eighty (180) will receive weekly doses of hydroxychloroquine for the duration of the study. Subjects who opt not to receive the study drug will form the control group.

NCT ID: NCT04333212 Completed - Clinical trials for Cervical Intraepithelial Neoplasia

HPV Genotyping by DR. HPV Genotyping in Vitro Diagnostic Device (IVD) Kit in Exfoliated Cells of the Uterine Cervix

Start date: December 12, 2012
Phase: N/A
Study type: Interventional

High-risk type human papillomavirus (HPV) is the known etiological agent of cervical cancer. HPV testing and risk stratification by genotyping has been recognized as an effective cervical screening program. A chip for HPV DNA typing based on type-specific polymerase chain reaction (PCR), DR. HPV Genotyping IVD Kit (HPV-27) was developed for genotyping of 27 common HPV types including all high-risk types. We studied its agreement, sensitivity, and specificity compared to DNA sequencing as the gold standard.

NCT ID: NCT04332991 Completed - Coronavirus Clinical Trials

Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease

ORCHID
Start date: April 2, 2020
Phase: Phase 3
Study type: Interventional

ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.

NCT ID: NCT04332861 Completed - Sepsis Clinical Trials

Evaluation of Infection in Obstructing Urolithiasis

eIOU
Start date: September 3, 2019
Phase:
Study type: Observational

Obstructing urolithiasis can be life-threatening in the setting of urinary tract infection. The purpose of this study is to identify and validate risk factors and markers for the presence of infection and development of sepsis among patients with obstructing urolithiasis.

NCT ID: NCT04332848 Recruiting - Clinical trials for Helicobacter Pylori Infection

Susceptibility Testing Guided Versus Empirical Therapy for Refractory H. Pylori Infection

Start date: July 24, 2020
Phase: Phase 4
Study type: Interventional

Aim: Therefore, we aimed to 1. compare the efficacy of susceptibility testing guided therapy vs. empirical therapy in the third-line eradication for refractory H. pylori infection 2. assess the long-term impact of eradication therapy on the antibiotic resistance and microbiota of the gut flora and the metabolic factors. Methods: This will be a multi-center, open labeled trial Patients: 360 patients with failure to H. pylori eradication for at least two times will be enrolled Determination of antibiotic resistance of H. pylori: Agar dilution test will be used to determine the minimum inhibitory concentrations of levofloxacin, tetracycline, rifabutin, and clarithromycin to guide the selection of antibiotics. Treatment regimens and assignment: Eligible patients will be randomized to receive either one of the treatments (A) Susceptibility testing guided therapy or (B) Empirical therapy Outcome Measurement: Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) analyses. Secondary End Point: 1. Eradication rate according to per protocol analysis (PP analysis); 2. Frequency of adverse effects.