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224 active trials for COVID

Hypertonic Saline Nasal Irrigation and Gargling in Suspected or Confirmed COVID-19 (ELVIS COVID-19)

ELVIS COVID-19 is a pragmatic web-based Bayesian adaptive randomised controlled, parallel group trial of hypertonic saline nasal irrigation and gargling (HSNIG) compared to standard care in participants with clinically suspected or confirmed COVID-19 being managed at home.

Start: June 2020

Coagulation Changes Associated With COVID-19 Infection

This study will study the potential utility of the Quantra QPlus System in patients inflicted with COVID-19 disease.

Start: August 2020

Detecting SARS-CoV-2 in Tears

Purpose: To determine the presence of SARS-CoV-2 in tears To determine SARS-CoV-2 receptors in tear production system

Start: September 2020

In-Utero Vascular Accidents in Neonates From COVID-19 Infected Mothers

The pregnancy related pro-thrombotic state, in addition to the COVID-19 associated hypercoagulability may have unknown consequences to the developing fetus. Hence, this proposal seeks to address this question that may have important implications for women that contract this virus during gestation.

Start: August 2020

COVID-19 : Transcutaneous pO2 and pCO2 as Predictive Factors for Acute Respiratory Destress Syndrome in Patients Affected With SARS-Cov-2

The first case of a person infected with SARS-Cov-2 virus can be tracked back on November the 17th, 2019, in China. On March 11, 2020, the World Health Organization (WHO) declared COVID-19 outbreak a pandemic. On April 13, COVID-19 is affecting 210 countries and territories worldwide, about 2 million positive cases have been officially declared along with 115.000 deaths. The real number of infected and deaths is scarily higher, considering that up to 65% people are asymptomatic and thus, not tested. The percentage of patients with COVID-19 needed for intensive care unit (ICU) varied from 5 to 32% in Wuhan, China. It was up to 9% in Lombardy, Italy. According to available data from Lombardy, 99% of patients admitted to the ICU needed respiratory support (88% invasive ventilation, 11% non invasive ventilation). The aim of the present investigation is to test the hypothesis whether transcutaneous partial O2 and CO2 pressures may be reliable predictive factors for acute respiratory distress syndrome (ARDS) development in hospitalized clinically stable COVID-19 positive patients and to clarify the role of the Angiotensin Converting Enzyme 2 (ACE2) and its final product, angiotensin 2 (Ang II) in the pathogenesis of this systemic disease. We also aim to test the hypothesis that plasma concentration of Clara Cell protein (CC16) and surfactant protein D (SPD), which are a biomarkers of acute lung injury, are severely decreased in COVID-19 positive patients and the plasma concentration is related to the severity of lung injury.

Start: October 2020

The Use of Ultrasound in Establishing COVID-19 Infection as Part of a Trauma Evaluation

The current COVID-19 pandemic is providing healthcare organizations with considerable challenges and opportunities for rapid cycle improvement efforts, in diagnostic and patient management arenas. Healthcare providers are tasked with limiting the use of personal protective equipment while minimizing unnecessary exposures to the virus. Results from real-time PCR tests to detect active COVID-19 infections may not be available in a timely fashion during emergent trauma assessments. Since the start of the COVID-19 pandemic, a rapidly expanding body of literature has identified a pattern of imaged lung abnormalities with CT and ultrasound (US) characteristic of an active viral infection. US evaluation provides a reliable, portable, and reproducible way of evaluating acute patients in a real time setting. During initial trauma evaluations, patients may also receive adjunct imaging modalities like the Focused Assessment with Sonography in Trauma (FAST) exam designed to discover life threatening findings that may require urgent interventions. We therefore propose a study expanding on the current FAST adjunct evaluation in the trauma bay that may include lung parenchyma imaging at the initial assessment to help stratify patients into low or high-risk groups for active COVID-19 infections. We believe the use of point of care US in the initial assessment of the trauma patient may help identify potentially infected individuals and aid ED providers to best directing subsequent laboratory and imaging evaluations for these patients, while further directing the necessary protective measures for additional team members involved in the care of the injured patient.

Start: July 2020

Does Quality of Life Decline During the COVID-19 Pandemic and Can we Change Behaviour to Improve Poor Quality of Life?

The response to COVID-19 means social isolation/distancing for the majority of the UK. This has the potential to negatively affect all domains of quality of life (QoL). QoL can be improved by giving feedback on gaps between someone's perceived QoL in a domain and how important it is to them (plus prompting reflective questions). However, interventions that are designed to improve QoL may increase the effectiveness of this as optimised behaviour change techniques can be used. This study aims to develop and test a quality of life intervention during social isolation/distancing.

Start: May 2020

PROne Positioning in coVID-19 Oxygeno-dependent Patients in Spontaneous Ventilation (PROVID Study)

The COVID epidemics is responsible for a huge number of death following COVID acute respiratory failure. First instance treatment includes oxygenotherapy up to 15L/min in spontaneous ventilation. However COVID infection can ultimately lead to an acute respiratory distress syndrome (ARDS) requiring mechanical ventilation in the intensive care unit (ICU). Guidelines on ARDS management are based on small ventilation volume (6 mL/kg), a pulmonary end expiratory pressure (PEEP) chosen to get the best pulmonary compliance, a plateau pressure lower than 30 cm of water and daily prone positioning when PaO2/FiO2 ratio is lower than 150. In ventilated ARDS patients, prone positioning has shown survival improvement. Though they applied this optimized management of ARDS patients, Chinese intensivists have recently reported mortality rate higher than 50% in ARDS COVID patients requiring intubation and mechanical ventilation. Before being intubated and admitted to ICU, COVID patients require increasing rate of oxygen delivery. From the start of the epidemics, we have observed that an oxygenotherapy rate higher than 3L/min at the initial phase of the disease was associated with a high risk of severe acute respiratory distress (30%) The investigators hypothesize that prone positioning in patients in spontaneous ventilation (not tubed) from the stage of oxygenotherapy higher than 3L/min (to get an SpO2 of 95% or higher) would prevent respiratory worsening and the need for intubation. Prone positioning is easy to apply in patients in spontaneous ventilation since they can change position by themselves.

Start: June 2020

An Adaptive Clinical Trial of Antivirals for COVID-19 Infection

This is a randomised placebo controlled phase II trial to examine the efficacy of antivirals to treat COVID-19 infection compared to placebo for virological cure and improved clinical outcomes. Individuals will be randomised to the candidate antiviral which in the first instance is Favipiravir or matched placebo and randomisation will be stratified according to whether the participant requires hospitalisation or not. This treatment will be given in addition to the usual standard of care in the participating hospital.

Start: August 2020

Effectiveness and Safety of Convalescent Plasma Therapy on COVID-19 Patients With Acute Respiratory Distress Syndrome

Corona virus disease 2019 (COVID-19) has been declared as a Pandemic by the World Health Organization (WHO). According to WHO report on March 31st 2020, globally COVID-19 have infected over 750,000 people and caused over 36,000 deaths with case fatality rate of 4.85%. In Indonesia, COVID-19 have infected 1,414 people and caused 122 deaths with case fatality rate of 8.63%. In severe cases, COVID-19 causes complications, such as acute respiratory distress syndrome (ARDS), sepsis, septic shock, and multi-organ dysfunction syndrome (MODS), where age and comorbid illnesses as a major factor to these complications. Up to this point there are several promising therapies for COVID-19 but is not yet recommended and in need of further research. The use of convalescent plasma has been approved by the US Food and Drug Administration (FDA) through the scheme of emergency investigational new drug (eIND). This method has been used as the treatment in several outbreak or plague cases over the years, such as the flu epidemic in 1918, polio, measles, mumps, SARS (severe acute respiratory syndrome), EVD (Ebola virus disease) and MERS (middle-eastern respiratory syndrome) and this treatment shows better outcome. Several case report on the use of convalescent plasma for COVID-19 patients with ARDS and mechanical ventilation has been reported and shows promising outcome. Nevertheless, larger and multicenter research need to be done to assess and evaluate the effectiveness and safety of convalescent plasma therapy on for COVID-19 patients with ARDS.

Start: May 2020

Prone Positioning and High-flow Nasal Cannula in COVID-19 Induced ARDS

Prone position (PP) has been proved to be effective in severe ARDS patients. On the other hand, High flow nasal cannula (HFNC) may prevent intubation in hypoxemic Acute respiratory failure (ARF) patients. Our hypothesis is that the combination of PP and HFNC in patients with COVID19 induced ARDS may decrease the need of mechanical ventilation. Primary outcome: Therapeutic failure within 28 days of randomization (death or intubation). Secondary outcomes: to analyze PP feasibility and safety in HFNC patients and to analyze effectiveness in terms of oxygenation. Methods: multicentric randomized study including patients with COVID19 induced ARDS supported with HFNC. Experimental group will received HFNC and PP whereas observation group will received standard care. Optimization of non-invasive respiratory management of COVID19 induced ARDS patients may decrease the need of invasive mechanical ventilation and subsequently ICU and hospital length of stay.

Start: May 2020

The Açaí Berry COVID-19 Anti-Inflammation Trial

The Açaí trial will be testing if the açaí berry extract, a safe natural product with anti-inflammatory properties, can be used as a treatment option in adult patients with COVID-19 in the community.

Start: August 2020

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

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.

Start: May 2020

Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia

CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled trial, which aims to assess the safety and efficacy of treatment with convalescent plasma for patients with moderate-severe COVID-19. Participants will be randomized 2:1 to two parallel treatment arms: Convalescent plasma, and intravenous placebo. Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.

Start: May 2020

Coagulopathy in COVID19 - A Multi-Centre Observational Study in UK

A novel Coronavirus (COVID-19) infection leading to pneumonia and severe acute respiratory failure [acute respiratory distress syndrome (ARDS)] and death is a global threat. On 11/03/2020, WHO declared the Covid-19 outbreak a global pandemic. As of 18th of March, there are 202,309 confirmed cases with 8,013 deaths. Patients with severe illness may develop dyspnoea and hypoxemia within 1week after onset, which may quickly progress to ARDS or end-organ failure 1. Based on Chinese data abnormal coagulation parameters (Prolonged Prothrombin time [PT] and raised D dimer) are reported to predict a poor prognosis and may therefore be important therapeutic targets. The number of patients with infected with COVID- 19 in UK is rapidly rising as with many other European countries. Eventually >50% of people will have become infected and COVID-19 will remain a public health threat in the long term. It is therefore very important to understand every aspect of this disease, including the associated coagulopathy leading bleeding, blood clots (thrombosis) and death. Emerging data from Europe and some centres in UK, indicates that venous thromboembolism (VTE), mainly pulmonary embolism (PE), is major problem in COVID patients. In this retrospective-prospective: multicentre study, investigators will document the patient characteristics, presenting haematological parameters and associated comorbidities and their association with bleeding, thrombosis and mortality in patients admitted for hospital treatment. Determining the predictive value of patient characteristics and presenting laboratory measurements for clinical outcomes in these patients will allow us to optimise management of these patients in the future. Furthermore, by comparing these data with data from patients without Covid-19, investigators will be able to modify existing protocols and tailor them to the management of COVID -19.

Start: May 2020

Knowledge, Attitudes, and Practices Towards COVID-19 Among Health Care Professionals Among Healthcare Professionals

The aim of this study is to evaluate the knowledge level of healthcare professionals such as physicians, nurses, physiotherapists and nutritionist about published COVID-19 guidelines. The listed healthcare workers are take part in the primary treatment of the Corona virus infected patients in hospitals. Therefore the knowledge of the world wide spreading Corona Virus and its effects for the human being is should be known for the effective treatment and for raising public awareness.

Start: August 2020

Early Treatment With Ivermectin and LosarTAN for Cancer Patients With COVID-19 Infection

Ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19

Start: July 2020

imPROving prenaTal carE During ConfinemenT

This study is a non-randomized, quasi-experimental, monocentric study comparing two prenatal monitoring modes in low-risk pregnancy: including at least one remote consultation (phone or teleconsultation) versus face-to-face adapted to confinement. The quality of care perceived by the pregnant women were evaluated according to monitoring modes set up during the COVID-19 pandemic confinement period. The women included planned to give birth at the regional academic Maternity of Nancy, France.

Start: April 2020

BCG Vaccine in Reducing Morbidity and Mortality in Elderly Individuals in COVID-19 Hotspots

Rationale: SARS-CoV2 viral infection is spreading rapidly throughout the world and in India the epidemic poses a major threat to the public health system. Elderly individuals, especially those with diabetes, hypertension, other chronic diseases are at high risk of mortality. Strategies to protect these individuals are desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in-vitro and in-vivo studies, and reported significant reductions in morbidity and mortality. Based on the capacity of BCG to reduce the incidence of respiratory tract infections in children and adults, to exert antiviral effects in experimental models; and to reduce viremia in an experimental human model of viral infection, the hypothesis is that BCG vaccination will partially protect against mortality in high-risk, elderly individuals. Primary Objective: To evaluate the effectiveness of BCG vaccination in preventing morbidity and mortality due to COVID-19 in elderly individuals aged between 60 to 80 years living in COVID-19 hotspots in India. Secondary objectives: To evaluate the effectiveness of BCG vaccination in terms of reducing the cumulative incidence of hospital admission and Intensive Care admission reducing the incidence of other respiratory febrile illness To determine the innate and adaptive immune responses, IgM, IgG and IgA antibody titers generated by BCG vaccination (both total and SARS-Cov2 specific) in a subset of individuals. To measure biomarkers induced by BCG vaccination as correlates of risk/protection against SARS-Cov2 in a subset of individuals Method and Analysis: Study design: Intervention study Study population: Elderly 60 - 80 years of age residing in designated hotspots for SARS-Cov2 infection Study Intervention: One dose of 0.1ml BCG vaccine, given intradermally. Elderly individuals not vaccinated from the same hotspot area or from neighbouring hotspot wards areas will be considered as the controls. Study sites: Chennai, Mumbai, Ahmedabad, Bhopal, Jodhpur and New Delhi. Study Sample size: 1450 individuals between 60-80 years of age will receive BCG vaccination while 725 individuals will be controls without vaccination Study duration: 6 months/participant. Enrolment at each site will be over: 4 months. Each participant will be followed for 6 months post vaccination. Primary Outcome Measures: During the study period (6-months), Proportion of individuals receiving the BCG vaccination who are asymptomatic but become PCR-positive or seroconvert during the 6-month of study period. Proportion of patients with development of COVID-19 disease (either PCR-positive or seroconvert with symptoms) during the study period. Proportion of patients with Severe COVID-19 disease and death due to Covid-19 disease

Start: July 2020

To Study the Clinical Characteristics and Treatment Outcome of COVID-19 Patients Admitted in Hospitals of Max Healthcare (SCOPe Study)

This is an observational study for Corona virus disease by the Max Healthcare.Corona virus 2019 disease (COVID-19) is a respiratory tract infectious disease caused by a newly emergent corona virus. This virus is linked to the same family of viruses as Severe Acute Respiratory Syndrome (SARS) and some types of common cold.

Start: April 2020