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 170 of 277GAAD Medical Research Institute Inc.
The human immune system is enhanced by exposure to infrared radiation with the wavelength of 5 microns to 20 microns. Humans, at normal body temperature, radiate most strongly in the infrared at a wavelength of about 10 microns. Infrared energy sustains life and can be used to treat and prevent diseases, including Covid-19 infections. High temperature within the fever range obtained from infrared radiation causes the killer T-Cells to profilate. The Killer T-Cells improves ones immune system. The high temperature kills the Corona virus. In addition, multi-vitamins and minerals including high doses of Vitamin C, increase one's immune system. Vitamin C is an anti-oxidant, produces hydrogen peroxide and removes free radicals from the body. Pre-clinical trials conducted in Houston, Texas, using Vitality Therapy or the Bible Cure were successful in curing Covid-19 infections. It is therefore possible that Vitality Therapy or the Bible Cure can be used for the successful prevention and treatment of coronavirus infections.
University of California, Irvine
The investigators are enrolling 100 healthcare Provider volunteers (n=100) from across the United States to help to evaluate and document the financial impact of COVID-19 on Physicians and other healthcare Providers. This investigation will compare individual Physician revenues before and after the advent of the COVID-19 pandemic. The investigators expect to be able to differentiate between revenues lost due to the COVID-19-driven business recession and revenues lost due to the manipulation of reimbursement processes by insurance companies. The inextricable linkage between Payer and Physician revenues suggests that Payer revenues are higher at the direct expense of Physicians, since both streams come from the same sources of funding. The secondary objective is aimed at revealing the methods Payers use to retain more money.
University Hospital Tuebingen
This is a prospective, longitudinal study to determine the incidence of SARS-COV-2 infection in children and adolescents by measuring specific antibodies in non-invasive saliva sampled in kindergartens and schools in a defined city area. The study includes an additional arm to validate the ELISA for anti-SARS-COV-2 reactive antibody measurements in saliva compared against blood collected in adult volunteers in a bimonthly follow-up period for 12 months.
Siew Chien NG
In December 2019, a cluster of pneumonia cases of unidentified cause emerged in Wuhan,was identified as the culprit of this disease currently being identified as "Coronavirus Disease 2019" (COVID-19) by World Health Organization. Coronavirus was found to not only target the patient's lungs but also multiple organs. Around 2-33% of Coronavirus Disease-19 patients developed gastrointestinal symptoms. Studies have shown that Severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) was found in patient's feces, suggesting that the virus can spread through feces. In our previous study, stool samples from 15 patients with COVID-19 were analysed. Depleted symbionts and gut dysbiosis were noted even after patients were detected negative of SARS-CoV-2. A series of microbiota were correlated inversely with the disease severity and virus load. Gut microbiota could play a role in modulating host immune response and potentially influence disease severity and outcomes. The investigators are uncertain about the impact of synbiotic on patients with COVID-19. However, a therapeutic strategy aiming at investigating the gut Imicrobiota of patients with COVID-9 who take synbiotic or not, leading to lesser progression to severe disease, less hospital stay and improved quality of life.
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.
Qilu Hospital of Shandong University
The novel coronavirus (SARS-CoV-2) is a new strain of coronavirus found in human in 2019, which causes epidemic worldwide. Novel coronavirus disease (COVID-19) causes acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in patients with severe COVID-19. Pulmonary edema is the key detrimental feature of ALI/ARDS. Autopsy of patients died from COVID-19 reported that, pulmonary mucus exudation was more severe and obvious than SARS infection. Pulmonary CT scanning and pathological findings also suggest that pulmonary edema caused by inflammatory exudation is a distinguished feature of COVID-19. Vascular endothelial growth factor (VEGF), also known as vascular permeability factor (VPF), is known as the most potent factor to increase vascular permeability, with the induction effect 50,000 times stronger than histamine. Bevacizumab is an anti-VEGF recombinant humanized monoclonal antibody, which has been used in anti-tumor treatment since 2004, with considerable reliability and clinical safety. This trial will provide high level evidence to answer whether bevacizumab is efficacy and safe medication for patients with severe COVID-19.
Tongji Hospital
To analyze the intubation with severe covid-19 pneumonia, the infection rate of anesthesiologist after intubation, and summarizes the experience of how to avoid the infection of anesthesiologist and ensure the safety of patients with severe covid-19 pneumonia.
Karolinska University Hospital
Initially, it was suspected that Covid-19 would primarily affect the airways, but several studies have now shown that it is a disease with multisystem manifestations. Covid-19 has the potential to affect physical, cognitive, and psychological functions in multiple ways. It has been clear that a significant proportion of patients with Covid-19 develop long-term symptoms. The term post-acute Covid-19 syndrome (PACS) is now used to describe the wide range of prolonged symptoms following the infection. Patients who have been in hospital for Covid-19 for a long time may need specialized rehabilitation, however, also non-hospitalized patients with mild symptoms may need specific rehabilitation to be able to meet the complex symptoms and problems that may arise. Previous studies on the recovery and rehabilitation after other coronavirus shows the importance to develop tailored interventions so that these patients receive appropriate rehabilitation The aim of this study is to evaluate the effects of inspiratory muscle training on adult patients with PACS and decreased respiratory muscle strength. A randomized controlled trial will be used. A total of 90 adult patients with PACS and 80 % or less of predicted value in inspiratory muscle strength (maximal inspiratory pressure) will be eligible for enrollment. Patients will be randomized either to an intervention group or a control group. The intervention will consist of inspiratory muscle training performed twice daily for 8 weeks. This will be combined with an 8-week physical exercise training program. The control group will perform the same physical exercise training according to standard care. All measurements will be performed at baseline and after 8 weeks. Primary outcome is maximal inspiratory pressure. Secondary outcomes are: Maximal expiratory pressure, pulmonary function, physical capacity, physical activity, respiratory status and symptoms, health-related quality of life, work ability, fatigue, self-reported outcome measure of physical function and voice function. Covid-19 has the potential to affect physical, cognitive, and psychological functions in multiple ways and lead to a negative impact on quality of life in the long-term perspective. Therefore, development of a rehabilitation program with specific tailored interventions will be necessary to improve physical and psychological function, as well as health-related quality of life and work ability.
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.