Around the world, researchers are working extremely hard to develop new treatments and interventions for COVID-19 with new clinical trials opening nearly every day. This directory provides you with information, including enrollment detail, about these trials. In some cases, researchers are able to offer expanded access (sometimes called compassionate use) to an investigational drug when a patient cannot participate in a clinical trial.
The information provided here is drawn from ClinicalTrials.gov. If you do not find a satisfactory expanded access program here, please search in our COVID Company Directory. Some companies consider expanded access requests for single patients, even if they do not show an active expanded access listing in this database. Please contact the company directly to explore the possibility of expanded access.
Emergency INDs
To learn how to apply for expanded access, please visit our Guides designed to walk healthcare providers, patients and/or caregivers through the process of applying for expanded access. Please note that given the situation with COVID-19 and the need to move as fast as possible, many physicians are requesting expanded access for emergency use. In these cases, FDA will authorize treatment by telephone and treatment can start immediately. For more details, consult FDA guidance. Emergency IND is the common route that patients are receiving convalescent plasma.
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Displaying 50 of 270Ziekenhuis Oost-Limburg
COVID-19 is a rapidly spreading and very contagious disease caused by a novel coronavirus that can lead to respiratory insufficiency. In many patients, the chest radiograph at first presentation be normal, and early low-dose CT-scan is advocated to diagnose viral pneumonia. Lung ultrasound (LUS) has similar diagnostic properties as CT for diagnosing pneumonia. However, it has the advantage that it can be performed at point-of-care, minimizing the need to transfer the patient, reducing the number of health care personnel and equipment that come in contact with the patient and thus potentially decrease the risk of spreading the infection. This study has the objective to examine the accuracy of lung ultrasound in patients with proven COVID-19 pneumonia.
Shanghai Asclepius Meditec Inc.
This study will evaluate the efficacy and safety of Hydrogen-Oxygen Generator with Nebulizer (model AMS-H-03) developed by Shanghai Asclepius Meditech Co., Ltd. as an adjuvant therapy for the patients with COVID-19 infected pneumonia in improving the clinical symptoms and reducing the incidence of severe pneumonia, as compared with the reference device of EverFlo Oxygen Concentrator (registration certificate No.: NMPA Registration Standard: 20162542389) manufactured by Respironics, Inc. US.
Assiut University
A pneumonia of unknown cause detected in Wuhan, China was first reported to the WHO Country Office in China on 31 December 2019. The outbreak was declared a Public Health Emergency of International Concern on 30 January 2020. The spread and severity of the disease is variable from one country to another. Our team as well as many reports suggested that in some countries a " Flu like illness but much worse" was described in October, November and early in December before the WHO announcement. Was it COVID-19?
Royal National Orthopaedic Hospital NHS Trust
Magnetic Expansion Control (MAGEC) growth rods are used in the surgical treatment of children with scoliosis; the primary constituent metal alloy in these is titanium. Since June 2019, the manufacturer has released two Urgent Field Safety Notices (FSN) relating to known issues with the function of the rods that increase the risk of early failure and unplanned revisions. The UK MHRA has issued two similar Medical Device Alerts (MDA) with the most recent MDA issued on 1st April 2020, stating that (1) MAGEC rods must not be implanted in the UK until further notice and (2) all patients already implanted with this device should be followed up as soon as is possible. At the time of writing, hospitals across the world are facing incredible challenges in dealing with the COVID-19 pandemic. Due to this, virtually all planned clinic visits for MAGEC rod patients and X-ray appointments have been postponed to help reduce the risk of the virus spreading. Recent retrieval studies have shown that mechanical wear and corrosion of these rods is common, with a risk that the debris generated is released into surrounding tissue. This wear and corrosion is thought to be the primary cause of implant failures and the underlying implant factors leading to the issuing of FSNs and MDAs. Whilst titanium is known to be highly biocompatible, the baseline and toxic levels of this alloy in biological fluids are poorly understood. Additionally, a better understanding of blood titanium levels in patients with MAGEC rods may enable this to become a biomarker of wear and corrosion of the rods. This may help surgeons identify earlier those patients who may develop implant related problems. Furthermore, in the current COVID-19 environment, a blood test to measure titanium levels may be one of the most suitable ways in which to continue patient monitoring (and identify those at greatest risk of implant related issues), in the absence of regular clinic visits. Previous work from the RNOH involved a similar study investigating patients with titanium hip implants.
Memorial Hermann Health System
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen responsible for the novel coronavirus disease 2019 (COVID-19). The first reports of COVID-19 came from Wuhan, China in December of 2019. Since then, the disease has spread rapidly around the globe, accounting for thousands of deaths in multiple countries. On March 11th, 2020, the World Health Organization declared COVID-19 as a pandemic. Although COVID-19 manifests primarily as a respiratory illness, several cardiovascular implications have been reported related to its natural course and treatment. Its exact effect on the cardiovascular system though is currently unknown. Therefore, we propose a retrospective, observational, case-control study looking for cardiovascular manifestations of COVID-19, including laboratory evidence of myocardial injury, electrocardiographic changes, arrhythmias and echocardiographic abnormalities. Hospitalized patients admitted with fever, cough, sore throat, and/or dyspnea who were tested positive for SARS-CoV-2 will be included in our study and will be matched based on their age and gender with patients admitted with similar symptoms who tested negative for SARS-CoV-2. The electronic medical charts of the study subjects will be reviewed and relevant demographic, clinical, laboratory and imaging findings will be deidentified and recorded. Since our study will be a retrospective chart review study it carries minimal risk for the patients and the investigators. Cardiovascular disease associated with COVID-19 might be contributing to the high mortality rates and its recognition will allow for prevention, early diagnosis and appropriate treatment. This will be the first, large, case-control study assessing cardiovascular involvement of COVID-19 in a well-defined cohort of patients.
Universidad de Granada
The new outbreak of the SARS-CoV-2 coronavirus is causing an important pandemic affecting a large number of people all-over the world. Vitamin D is a hormone precursor produced by our own body with the help of sunlight which has an important role on adaptive immunity and cellular differentiation, maturation and proliferation of several immune cells. Reduced levels of vitamin D in calves were positioned as the main cause of bovine coronavirus infection in the past. Therefore, it seems plausible that the use of vitamin D as a nutritional ergogenic aid could be a potential intervention to fight against COVID-19 infected patients which remain asymptomatic or which have non-severe and severe symptoms. This study aims to investigate whether the use of vitamin D as an immune modulator agent induces significant improvements of health status and outcomes in non-severe symptomatic patients infected with COVID-19 as well as preventing COVID-19 health deterioration. We hypothesize that vitamin D will significantly improve hard endpoints related to COVID-19 deleterious consequences compared with a usual care control group.
University of Arizona
Due to the COVID-19 global health pandemic, many people are likely experiencing increased stress. The well-being of physicians in training may be significantly impacted by this pandemic. Meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time. The investigators propose a prospective evaluation of perceived stress, anxiety, burnout and sleep disturbance in the house staff at Banner University Medical Center Phoenix, with the use of the mobile meditation app, "Calm." The investigatros additionally want to evaluate the feasibility of using the mobile app, including looking at adherence to use of the app and physician satisfaction with use of the app.
Shahid Beheshti University of Medical Sciences
During the new COVID-19 pandemic physicians all over the world have faced different challenges .Oxidative stress is a probable cause of multi organ failure in this setting which never has been evaluated in COVID-19 infection to the best of knowledge.Present study aimed to evaluate oxidative stress marker and redox system status in different COVID-19 patients regarding the severity of involvement.
Università degli Studi dell'Insubria
SARS-CoV-2 belong to beta-coronavirus family and its transmission route and symptoms follow those of all community-acquired coronaviruses. The main difference of the novel Coronavirus is the higher mortality rate, that is around 3%. Death rate is over 1% only for patients over 50 years old, whereas until 40 years old is under 0,4%. No fatalities are declared among children under 10 years old to date. Death rate is almost double for male rather than female. This distribution of mortality rate according to age of infected patients could be only partially ascribed to other comorbidities in addition to great age. In fact, patients with no pre-existing conditions have however a case fatality rate of 0,9%. The almost null rate of severe illness in children and generally in patients younger than 40 years old is quite un-explicable. Infant, children and young people could be infected but infection is rapidly self-limited or without symptoms. Older patients undergo severe lung injury as consequence of an immune response that is late in coming. Possible explanation of these phenomena could be something, which assure ability to prompt response to SARS-CoV-2 in younger people independently from the novelty of the virus itself. It would seem to be that younger people are already sensitized to the antigens of the virus without a previous contact. This immunity is not really specific, but "partially specific" for many antigens of the virus, however able to limit the infection in the organism. Something stimulated the immune system and it scattered immunity against more and more antigens present. Children are the age group mostly exposed to all community-circulating viruses. This immunity is not persistent but progressively fade out. It protects from the age of two, when the hypothetical stimulation occurs, to the fifth decade because of its slow decrease. The only external stimulation, which healthy people receive are vaccines. All vaccinations and especially tetanic, diphtheria toxoids and inactivated bacteria as pertussis could stimulate immune system. They develop the specific immunity but generate also a sprouting immunity against antigens in transit, as coronaviruses and other community-circulating viruses. The developed immunity gives some protection against multiple viral infection for years until the natural fade out. After the fifth decade, that immunity is slower to be recall and reactivated. Additionally, transplant recipients and HIV infected patients, which have an immune system inhibited, unexpectedly, do not seem to suffer the worst complications of SARS-CoV-2 infection. An immune system imbalance could be play a pivotal role during the reaction to the virus, limiting destructive consequences of excessive inflammation. According to the medical hypothesis on which the protocol is based on, young people could benefit from a functional adaptation of innate immune cells induced through epigenetic reprogramming and, especially, a pre-existing "partially specific" immunity to the community viruses caused by "bystander effect" of preceding vaccinations. In this study, we will explore the main differences existing among patients infected by SARS-CoV-2 who experience the illness at different degree of severity. We suppose to recognize different populations of patients, each one with a specific immunological pattern. It could differ in terms of cytokines, soluble factors serum level and immune cells activity both of the innate compartment and of the acquired one. The proof of a role of these immunological phenomena in the pathogenesis of Covid-19 are bases for implementation of therapeutic immunomodulatory treatments. In addition, the definition of an immunological risk profile could tailor established therapies to each kind of patient.
Northwestern Medicine
The purpose of this study is two-fold. First we would like to confirm that non-contact ECG provides equivalency to current contact methods of obtaining ECG data. Second we would like to investigate whether non-contact ECG can detect ECG changes prior to the onset symptoms from COVID19.