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Covid19 clinical trials

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NCT ID: NCT04403672 Recruiting - Clinical trials for High Sensitivity and Specificity (With 95% Confidence Interval) of RealDetect™ COVID-19 RT-PCR Kit

Performance Evaluation of RealDetect™ COVID-19 RT-PCR Kit for the Detection of SARS-CoV-2 Virus

Start date: May 18, 2020
Phase:
Study type: Observational [Patient Registry]

The novel Severe acute respiratory syndrome coronavirus 2 (SARS-C0V 2) originated in Wuhan, China in December 2019. As of April 15 2020, the virus has spread across 213 countries/territories with 1,914,916 cases and 123,010 deaths and a crude case fatality ratio (CFR) of 6.4%. In Bangladesh, the situation is also grave. As of May 14, 2020, there were 18,863 cases and 283 deaths. In order to suppress COVID-19 transmission, it is important to diagnose COVID-19 patients, which would help in the process of quarantine and isolation of the patients and also in contact tracing. COVID-19 testing can identify the SARS-CoV-2 virus and includes methods that detect the presence of virus itself such as real time reverse-transcription-polymerase chain reaction (RT-PCR), isothermal nucleic acid amplification, antigen) and those that detect antibodies produced in response to infection. Until now, RT-PCR has been known as the best approach for - detection. It would be very useful if Bangladesh had its own locally produced RT-PCR kits, provided that the kits are no less in quality than imported kits in terms of sensitivity, specificity, price etc. The present study aims to carry out the performance evaluation of RealDetect RT-PCR Kit for COVID-19 detection. The RealDetect™ COVID-19 RT-PCR diagnostic panel is a locally produced real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab specimens collected from individuals who meet SARS-CoV-2 clinical criteria. The approach is based on the RT-PCR method which uses two (Nucleocapsid 1, Nucleocapsid 2) sets of gene-specific primers and corresponding fluorescent probes to detect two specific regions within the novel coronavirus (SARS-CoV-2) nucleocapsid protein Nucleocapsid gene. This RT-PCR panel detects SARS-CoV-2 Ribonucleic acid (RNA) specifically. The approach does not generate any false positives to other coronaviruses or human microflora. The kit also contains a primer-probe set which detects human housekeeping gene, ribonuclease Protein (RNase P). That is, the Ribonuclease Protein (RNase P) serves as an internal reference control to monitor sample collection, ribonucleic acid (RNA) extraction, and amplification. This is a case control study. The study will analyze 120 samples (60 COVID-19 positive and 60 COVID-19 negative both fresh and frozen) from Institute of Epidemiology, Disease Control and Research (IEDCR). These specimens will be blinded before handing over to Institute for Developing Science & Health Initiatives (ideSHi) for RealDetect Kit. All samples will be analyzed by Real Time PCR System. Necessary validation will also be carried out at the COVID-19 laboratory of the Dhaka Medical College Hospital and an external validation expert will be involved. The Principal Investigator (PI) will also receive the sample information regarding positive/negative status from Institute for Epidemiology, Disease Control and Research (IEDCR) and compare ideSHi and IEDCR data. Unpaired t-test, Wilcox's test, Rank test, Compare test, Mean test, Sensitivity/Specificity test, Regression analysis and Geometric mean with 95% Confidence Interval (CI) will be used to analyze the data. It needs to conduct a univariate analysis.

NCT ID: NCT04403646 Terminated - COVID-19 Clinical Trials

Tannin Specific Natural Extract for COVID-19 Infection

TanCOVID
Start date: June 12, 2020
Phase: N/A
Study type: Interventional

There is an urgent need to evaluate interventions that could be effective against the infection with SARS-CoV 2. Tannins based wood extracts are an inexpensive and safe product with protective effect in both bacterial and viral infections likely due to its anti- inflammatory, anti-oxidative effects and their modulation of the intestinal microbiota. This randomized controlled trial seeks to evaluate the efficacy of the tannins based dietary supplement ARBOX in positive COVID-19 patients.

NCT ID: NCT04403607 Enrolling by invitation - COVID Clinical Trials

Cardiac Imaging in SARS-CoV-2 (COVID-19)

CISCO-19
Start date: May 22, 2020
Phase:
Study type: Observational

One-in-four patients with COVID-19 pneumonia develop life-threatening heart problems. Through cardiovascular imaging and biomarkers analyses this study aims to evaluate whether COVID-19 infection results in heart injury. The investigators will also investigate which patients are at risk of heart injury as a result of COVID-19 and why only some patients suffer heart problems as a consequence of the infection. The study will also assess multisystem involvement including the lungs and kidneys.

NCT ID: NCT04403581 Not yet recruiting - Covid-19 Clinical Trials

Egyptian Doctors Stresses, Knowledge and Attitude During COVID-19 Pandemic

Start date: May 2020
Phase:
Study type: Observational

Doctors are at high risk of corona virus infection (COVID-19) during pandemic. The investigators are aiming to explore the emotions, perceived stressors, knowledge and coping strategies of doctors who are working during COVID-19 pandemic in different specialties and in different hospitals by a self assessment questionnaire that was designed and modified from two previously published articles (mentioned in the references), including 7 sections with 88 questions.

NCT ID: NCT04403555 Completed - COVID Clinical Trials

Ivermectin as a Novel Therapy in COVID-19 Treatment

Start date: June 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Efficacy of Ivermectin in COVID-19 treatment

NCT ID: NCT04403477 Recruiting - Covid19 Clinical Trials

Convalescent Plasma Therapy in Severe COVID-19 Infection

Start date: May 20, 2020
Phase: Phase 2
Study type: Interventional

As of March 18, 2020, COVID-19 cases were reported in approximately 195 countries. No specific therapeutic agents or vaccines for COVID-19 are available. Several therapies, such as remdesivir and favipiravir, are under investigation, but the antiviral efficacy of these drugs is not yet known. The use of convalescent plasma (CP) was recommended as an empirical treatment during outbreaks of Ebola virus in 2014. A protocol for treatment of Middle East respiratory syndrome coronavirus (MERS-CoV) with CP was established in 2015. This approach with other viral infections such as SARS-CoV, H5N1 avian influenza, and H1N1 influenza also suggested that transfusion of CP was effective. In previous reports, most of the patients received the CP by single transfusion. In a study involving patients with pandemic influenza A(H1N1) 2009 virus infection, treatment of severe infection with CP (n = 20 patients) was associated with reduced respiratory tract viral load, serum cytokine response, and mortality. In another study involving 80 patients with SARS, the administration of CP was associated with a higher rate of hospital discharge at day 22 from symptom onset compared with patients who did not receive CP. Accordingly, these findings raise the hypothesis that use of CP transfusion could be beneficial in patients infected with SARS-CoV-2. The objective of this study is to describe the initial clinical experience with CP transfusion administered to severe COVID-19 patients. The primary endpoint of this trial would be to assess the tolerability, efficacy, and dose-response of CP in severe COVID-19 patients. The secondary endpoint would be to assess the clinical and laboratory parameters after therapy, in-hospital mortality, length of hospital stay, reduction in the proportion of deaths, length of ICU stay, requirement of ventilator and duration of ventilator support. All RT-PCR positive cases with features of severe infection will be enrolled in this study. Apheretic CP will be collected from a recovered patient (consecutive two RT-PCR samples negative) between day 22 to 35 days of recovery and those with the antibody titre above 1:320. This RCT will consist of three arms, a. standard care, b. standard care and 200 ml CP and c. standard care and 400 ml CP as a single transfusion. Twenty (20) patients will be enrolled for each arm. Randomization will be done by someone not associated with the care or assessment of the patients by means of a random number table. Allocations will be concealed in sequentially numbered, opaque, sealed envelopes. Clinical parameters [fever, cough, dyspnea, respiratory rate, PaO2/ FiO2 level, pulse, BP, the requirement of O2, and others] will be recorded before and after CP. Laboratory parameters such as complete blood count, CRP, chest X-ray, SGPT, SGOT, S. Ferritin, and serum antibody titre will be measured before and after transfusion. Allergic or serum sickness-like reactions will be noted and adjusted with outcome. Laboratory tests including RT-PCR will be done at BSMMU virology and laboratory medicine department. Apheretic plasma will be collected at the transfusion medicine department of SHNIBPS hospital, ELISA, antibody titre will be done at CMBT, and patients will be enrolled at DMC and MuMCH. All necessary screening tests will be done before transfusion. Graphpad Prism v 7.0 will be used for analysis. One way ANOVA test, a non-parametric Mann-Whitney test, and a Kruskal-Wallis test will be performed to compare the arms. For parametric outcomes, the investigators will compare the odds ratios across the pairs.

NCT ID: NCT04403438 Enrolling by invitation - COVID Clinical Trials

Familial Mediterranean Fever and Behçet: Analysis Before and After Covid19 Pandemic

Start date: April 1, 2020
Phase:
Study type: Observational

Behcet' disease (BD) is a chronic inflammatory disease which is characterized by oral and genital ulcers, uveitis and skin lesions. Musculoskeletal involvement such as arthrits, arthralgia, enthesis and sacroiliitis can be seen in course of BD. FMF is an autosomal recessive family disease characterized by abdominal pain, chest pain, joint pain and fever attacks as a result of inflammation of the serous membranes. FMF patients have been shown to experience higher levels of pain, fatigue, depression and anxiety than healthy controls, and this has increased sleep disturbance and reduced quality of life. FMF and BiH have common characteristics such as ethnicity, etiopathogenetic mechanisms, symptoms, and treatment. In December 2019, after the officially detected coronavirus (severe acute respiratory syndrome coranavirus-2 [SARS-CoV-2]) resistant to unknown treatment and rapidly spreading coronavirus in our country on March 11, 2020 in Hubei province of China, the number of cases increased rapidly and virus was isolated in 670 patients within 10 days. Ongoing concerns about the spread of Covid-19 infections have caused many measures to be taken. Among them, social isolation, home quarantine and avoiding collective places are the most important. In our country, in the process of social isolation, the areas of movement of Behçet and FMF patients, like everyone else, were restricted, their stress and anxiety levels increased and their motivation decreased. The aim of our study is to compare the pain, sleep, fatigue, physical activity level and quality of life and question exercise habits before and after the covid-19 outbreak in patients with Behçet and FMF.

NCT ID: NCT04403386 Completed - COVID-19 Clinical Trials

Prospective Natural History Study of Smoking, Immune Cell Profiles, Epigenetics and COVID-19

Start date: June 1, 2020
Phase:
Study type: Observational

Background: Early evidence in the COVID-19 pandemic suggests that smokers are at a higher risk of having severe effects or dying from the disease. Smoking causes changes in immune cells. Researchers think this may be the reason why smokers are more likely to have severe effects from COVID-19. Researchers want to better understand the interaction between smoking history, the immune system, and COVID-19. Objective: To better understand how COVID-19 affects smokers and non-smokers immune systems before and after being infected with the virus. Eligibility: Healthy people ages 30-55 who are a smokers or non-smokers who may potentially contract COVID-19 Design: Participants will be screened over the phone. They will answer questions about their demographics, medical history, medications, and smoking status. Participants will have up to 6 monthly visits. At the first visit, participants will have blood tests. Blood will be drawn through a needle in an arm vein. They will provide a saliva sample in a container and have a cheek swab. The participant will also have a nasal swab to see if they currently have COVID-19. Their height and weight will be taken. They will complete questionnaires about their medical history and smoking status. Participants will then have monthly visits. They will have blood draws to test for COVID-19 antibodies. They will provide a saliva sample in a container and have a cheek swab. The participant will also have a nasal swab to see if they currently have COVID-19. These visits will occur 4 times or until they have a positive antibody result. Participants will have a final visit. They will have blood tests. They will provide a saliva sample in a container and have a cheek swab. The participant will also have a nasal swab to see if they currently have COVID-19. If at any time participants test positive for a COVID-19, they will be rescheduled 14 days or more after they no longer have symptoms....

NCT ID: NCT04403243 Completed - COVID 19 Clinical Trials

COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19

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

Patients with mild and severe coronavirus disease 2019 (COVID 19) will be randomized 3:1:1:3 into four groups: colchicine, ruxolitinib, secukinumab, and control groups. . Patients will be follow-up during 45 days after randomization. Change in clinical assessment score COVID 19 (CAS COVID 19) between baseline and 12th day will be evaluated as the primary endpoint. Risk of death or mechanical ventilation during 45 days after randomization will also be assessed

NCT ID: NCT04403100 Recruiting - COVID-19 Clinical Trials

Hydroxychloroquine and Lopinavir/ Ritonavir to Improve the Health of People With COVID-19: "The Hope Coalition - 1"

Start date: June 3, 2020
Phase: Phase 3
Study type: Interventional

The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in controlling this disease in hospitalized patients with moderate and / or severe cases of this disease. Hydroxychloroquine and lopinavir / ritonavir have been shown to inhibit SARS-CoV viral replication in experimental severe acute respiratory symptoms models and have similar activity against SARS-CoV2. Although widely used in studies of critically ill patients, to date, no study has demonstrated its role on the treatment of high-risk, newly diagnosed patients with COVID-19 and mild symptoms.