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 90 of 119Istanbul University
A prospective non-interventional study to evaluate the performance of EASYCOV IVD as point-of-care (POC) test by comparing SARS-CoV-2 positive patients with SARS-CoV-2 negative controls on paired specimens (nasopharyngeal swabs & saliva samples).
University of Erlangen-Nürnberg Medical School
Since the beginning of the year, the entire world has been concerned with the novel SARS-CoV2 virus. After the first case descriptions in Wuhan, there has been a rapid increase in the number of cases in Germany as well. In case of an illness with the virus, the affected patients can suffer from a slight infection of the upper respiratory tract up to severe lung failure and death. Interestingly, up to now, children are usually less severely affected than adults. However, the actual infection rates are probably similar to those of adults, even if the actual prevalence in children is difficult to quantify so far. The extent of the disease in children has also been less researched to date than in adults, and the same applies to pregnant women and their newborns. In addition, intensive research into possible therapeutic strategies and new vaccines is necessary. Here, however, the number of clinical studies in children is also far behind. In order to be able to understand the infection process and to protect the population with their children, comprehensive testing is necessary. However, this poses great challenges for local health authorities. Scientific investigations are also costly, but are already being carried out by many institutes. So far, for example in the SeBlueCo study, a very low prevalence of antibodies (1.3% of people) has been show. In children, however, both the routes of infection and the way the immune system deals with the virus are probably different than in adults. In this study the investigators now want to examine residual blood samples from pediatric patients of the pediatric and adolescent clinic in the time course after the beginning of the pandemic in order to better understand and monitor the development of antibody prevalence.
Hill-Rom
A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized with COVID-19
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Myocardial infarction (MI), as one of the many complications of COVID-19, is one of the contributing patients of patients' death. This study attempts on developing an intervention of MI by regenerating damaged cardiomyocytes due to insufficiency of oxygen in cardiac muscles, triggered by an occlusion of coronary artery (MI). Heart patch developed from amnion bilayer seeded with amnion epithelial stem cells and patient's autologous cardiomyocytes is used as a therapy. Patients who undergo bypass (CABG) surgery are given heart patch, and then patients condition are observed by ECG, Echo, blood test, and radiology (technetium-99m)
GlaxoSmithKline
The purpose of this study is to examine how patients with multiple myeloma (MM) have been impacted by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. The study will use a questionnaire to further understand how patients are being affected and gather information in order to track the long-term effects of the coronavirus. The scope of the questionnaire will include, COVID-19 diagnosis and treatment, changes in myeloma treatment and care, clinical trial familiarity, health and fitness, and quality of life. This questionnaire is a follow-on to the "MM and COVID-19" questionnaire.
University of Alabama at Birmingham
In this 30-month study, the investigators propose to develop a culturally appropriate vaccine confidence intervention, targeting positive change related to HPV vaccine uptake behavior and reducing sentiments of hesitancy towards a COVID-19 vaccine, that can be seamlessly integrated into the existing environment of pediatric and family practice clinics in rural Alabama. To do so, the investigators will first assess stakeholders' knowledge, sentiments, and beliefs related to vaccination in general, a COVID-19 vaccination, and the HPV vaccination. The investigators will also assess stakeholders' perceptions of barriers to vaccination that exist in rural Alabama. This will occur in Aim 1. Then, in Aim 2, the investigators will use these data to inform the development of a non-invasive, modular synchronous counseling intervention targeting 15-17 year old adolescents (rationale for this age range presented later in this proposal). After the intervention has been finalized, in our final aim, Aim 3, we will conduct a hybrid type 1 effectiveness-implementation cluster randomized control trial to assess intervention acceptability and feasibility (N=4 clinics; N=120 adolescents), while also assessing for a "clinical signal" of effectiveness. To support dissemination and scale up, also during Aim 3, we will document implementation contexts to provide real-world insight. To do this, the investigators will conduct in-depth interviews with the same groups of stakeholders that we interviewed in Aim 1.
Centre Hospitalier Universitaire de Saint Etienne
Current data in the literature demonstrate that the immune response to CoV-2-SARS is much more complex than initially assumed. In fact, beyond the humoral response, including the existence of neutralizing CAs, the adaptive lymphocyte T-type immune response also appears to play an important role in controlling the infection and reducing the severity of the disease. At this stage, the analysis of this T response is still rudimentary and underdeveloped, but it seems crucial to be able to analyze it effectively in COVID-19 patients, which could help predict the evolution of the infection. It is also currently difficult to know the evolution of this response over time and especially after the resolution of the infection. To this end, we will analyze the T lymphocyte response (ELISPOT and QUANTIFERON) based on the secretion of IFN (Th1) and IL-4 (Th2) by CoV-2-SARS specific T cells from COVID-19 patients. We will compare the T response to the quality of the systemic and mucosal humoral response. Finally, we will evaluate in parallel two new biomarkers of the severity of COVID-19: plasma calprotectin and the presence of antibodies to type 1 IFN antibodies.
University of Massachusetts, Worcester
The objective of this study is to better understand public attitudes towards coronavirus disease 2019 (COVID-19) vaccination. This understanding will inform the development of community engagement strategies to be used in future interventions and studies aimed at addressing factors that impact the disproportionate burden of COVID-19 in under-served and vulnerable communities.
Ohio University
The coronavirus (COVID-19) pandemic is a significant psychological stressor that threatens the onset of a mental health crisis in the US. Fear and anxiety about COVID-19 and its economic impact, as well as loneliness due to the required social isolation, are driving the mental health impacts of COVID-19; in a recent Kaiser Family Foundation poll, 45% of respondents reported that the coronavirus has had a negative impact on their mental health. This is reflected in Southeastern Ohio. In data that the investigators collected from 317 Ohio University faculty, staff, and students from late May to early June, 39% reported moderate-to-severe levels of anxiety, 41% reported moderate-to-severe levels of depression and 57% reported the COVID-19 outbreak was impacting their sense of social connection much or very much. Despite the significant community need for accessible and affordable care, there are currently no evidence-based interventions for individuals coping poorly with coronavirus-related distress. The investigators have developed a virtual group-based intervention targeting cognitive biases that amplify the experience of stress and anxiety (i.e., amplifying cognitions; Coping with Coronavirus-Related Emotion and Worry [COPING CREW]). The next step in developing this intervention in a scientifically rigorous manner is to refine the manual and procedures and conduct a pilot test of the intervention.
Yueh-Lin Hsu
With the aging of today's population, stroke is the top three causes of disability and death among people over the age of 60 in the world. About 5.5 million people die each year from strokes in Taiwan, and Taiwan's top ten causes of death in cerebrovascular disease rank fourth in the world. Constipation is the most common complication of stroke patients and increases the risk of brain damage and re-stroke. Although the clinical use of drugs can relieve intestinal symptoms, there is also a risk of potential side effects. The systematic literature points out that the use of acupoint stimulation can improve spontaneous bowel movements and promote bowel motility, but there is no conclusion on effective acupuncture points. Therefore, the purpose of this study is to improve the constipation of patients with stroke by non-invasive and precise acupoint care. This study used a single-blind randomized control trial. The neurosurgery ward of a medical center in the north was used as the research site, and patients with ischemic stroke were used as the research objects. The experimental group received precision acupoint care, and the control group received routine care. The questionnaire was used to collect basic patient information (basic attributes, disease care and TCM constitution), and gut-related assessments. Data analysis was performed using IBM SPSS 22.0 software for descriptive statistical analysis and inferential statistical analysis, and p