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 20 of 58Columbia University
The novel coronavirus (SARS-CoV-2) has spread all around the world and testing has posed a challenge globally. Health care providers are highly exposed and are an important group to test. On top of these concerns, health care workers are also stressed by the needs on responders in the COVID-19 crisis. The investigators will look at different ways to measure how common COVID-19 is among health care workers, how common is the presence of antibodies by serological tests (also known as serostatus). The investigators will describe health worker mental and emotional well-being and their coping strategies in their institutional settings. Lastly, the investigators will describe how knowing serostatus can affect individuals' mental and emotional well-being and how to cope in the midst of the COVID-19 response. This will help to how to better test and help healthcare workers in the COVID-19 pandemic and prepare for possible future outbreaks.
Robert W. Alexander, MD
COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up.. March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California. Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started. The recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied. This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.
Institut National de la Santé Et de la Recherche Médicale, France
In December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020. Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital. Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action. Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection. In this study, we aim to evaluate the virological and clinical outcomes of subjects following a contact at high/moderate risk of SARS-CoV-2 acquisition, in community-subjects and/or healthcare workers. The study population is represented by all subjects who had a contact with laboratory-confirmed SARS-CoV-2 cases and whose contact was considered to be at high/moderate risk of SARS-CoV-2 acquisition. This include both children and adult subjects, subject without social security, and healthcare workers.
Insel Gruppe AG, University Hospital Bern
COVID-19 patients with a severely symptomatic progression with development of an Acute respiratory distress syndrome (ARDS) due to SARS-CoV-2 need prolonged intensive care treatment involving pharmacological immobilization, sedation and mechanical ventilation, leaving them at a very high risk for developing Critical illness myopathy (CIM). CIM is associated with increased mortality and significant consequences for recovery and the ability to return to normal daily life. Up to date, there are no studies investigating the mid- or long-term course of the novel COVID-19 disease. The present study therefore aims to evaluate the clinical outcome of patients with ARDS due to SARS-CoV-2 with special attention to the development of CIM and its underlying causes. To provide the possibility of early diagnosis of CIM, critically ill patients will be regularly screened for muscle membrane alterations using (Muscle velocity recovery cycles) MRVC measurements. The primary endpoint is the incidence of CIM in patients with ARDS due to SARS-CoV-2, diagnosed according to the current diagnostic criteria.
University of Minnesota
The Professional Peer Resilience Initiative (PPRI) study is an observational study aimed at understanding how symptoms of traumatic stress and resilience evolve over time in the University of Minnesota (UMN) healthcare workforce during the coronavirus disease 2019 (COVID-19) pandemic. The study is being conducted concurrently with a UMN peer support program called the MinnRAP program and will remotely administer quality of life and mental health surveys to healthcare workers before they start the MinnRAP program and throughout their participation in the program.
Fundacion GenesisCare
The host response against the coronavirus 2 (SARS-CoV-2) appears to be mediated by a 'cytoquine storm' developing a systemic inflammatory mechanism and an acute respiratory distress syndrome (ARDS), in the form of a bilateral pneumonitis, requiring invasive mechanical ventilation (IMV) in an important group of patients. In terms of preventing progression to the critical phase with the consequent need of admission to the intensive care units (ICU), it has been recently proposed that this inflammatory cytoquine-mediated process can be safely treated by a single course of ultra-low radiotherapy (RT) dose < 1 Gy. The main purpose of the study was to analyze the efficacy of ultra low-dose pulmonary RT, as an anti-inflammatory intention in patients with SARS-Cov-2 pneumonia with a poor or no response to standard medical treatment and without IMV.
ExThera Medical Corporation
Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has caused a global pandemic and is associated with significant morbidity and mortality. The mortality rate for COVID-19 patients admitted to an intensive care unit (ICU) who require mechanical intubation is approximately 75%. While the pathophysiology of severe COVID-19 has yet to be fully understood, it is possible that a combination of high viral loads and an overactive dysregulated inflammatory response may contribute. Therefore, the clearance of SARS-CoV-2 virus and cytokines could provide a more opportunistic environment for the innate immune system to clear the virus and establish lasting immunity. The Seraph®-100 Microbind® Affinity Blood Filter (Seraph®-100) is an extracorporeal broad-spectrum sorbent hemoperfusion filter for removing virus and cytokines from the blood. The FDA authorized an Emergency Use Authorization (EUA) for treatment of severe COVID-19 with the Seraph®-100. As part of the EUA, this registry study will collect de-identified data to assess safety and efficacy on the use of Seraph®-100 Microbind® Affinity Blood Filter in the treatment of COVID-19 patients.
University Hospital Southampton NHS Foundation Trust
Trial Phase: Phase III: Interventional Trial: Virtual clinics to deliver universal interventions to maintain and improve physical health, nutritional state and psychological wellbeing in people with cancer who are following social distancing guidance: A COVID-19 targeted trial. Indication: Male or female participants, aged over 18 years old with suspicion or confirmed diagnosis of cancer (does not require histological confirmation) Objective: To investigate the efficacy of remote multimodal universal interventions delivered via virtual clinics to improve physical function as measured by the EORTC-QLQ-C30. Secondary Objective: To investigate the efficacy of remote multimodal universal interventions delivered via virtual clinics to improve emotional function, quality of life, participant activation (PAM), behaviour change and the effect it has on health economics (EQ-5D-5L). Exploratory Objective: Overall Survival and adherence to the intervention/advice using validated tools or development of a web-based toolkit.
Corporacion Parc Tauli
OBJECTIVE: The aim of the study is to demonstrate that the intracorporeal resection and anastomosis in left-sided colon cancer, sigma and upper rectum, is not inferior to extracoprporeal resection and anastomosis, in terms of anastomotic leakage. BACKGROUND: Due to the recent events of a pandemic respiratory disease secondary to infection by SARS-CoV-2 virus or coronavirus 19 (COVID19), surgeons have been forced to adapt our surgical procedures in order to minimize exposure to the virus as much as possible. Based on the recommendations in case of surgery in patients with highly contagious viral diseases, the latest studies suggest minimally invasive accesses to minimize the risk of contagion. One of the proposed measures is the performance of intracorporeal anastomoses. Therefore, given the extensive experience of our center in minimally invasive surgery and studies on the validation of intracorporeal anastomosis techniques in both laparoscopic surgery of the right colon and rectum (TaTME), and the study of advantages that they can provide to the patient, our intention is to apply it to surgery on the left colon, sigma and upper rectum. Our hypothesis is that exteriorization of the colon through an accessory incision increases the risk of tension at the mesocolon level, thus increasing the risk of vascular deficit at the level of the staple area and it may increase the rate of anastomotic leakage. In this sense, studies that validate a standard technique of intracorporeal anastomosis in left colon surgery and that demonstrate its benefit with respect to extracorporeal anastomosis are lacking. We intend to describe a new intracorporeal anastomosis technique (ICA) that is feasible and safe for the patient and that can be applied universally. Once the ICA technique is established, it will allow us to determine its non-inferiority compared to the standard technique performed up to now with extracorporeal anastomosis. METHODS: All consecutive patients with left-sided, sigma and upper rectum adenocarcinoma will be included into a prospective cohort and treated by laparoscopy with totally intracorporeal resection and anastomosis. They will be compared with a retrospective cohort of consecutive patients of identical characteristics treated by laparoscopy with extracorporeal resection and anastomosis, in the immediate chronological period.
Johns Hopkins University
The investigators aim to deliver a tele-wellness supported app to Baltimore City's Family Child Care Home (FCCH) providers who are caring for children of Essential Personnel. Once a pre-survey is conducted, login information will be assigned to 30 Family Child Care Home providers and parents the FCCH serve. Providers and Parents will receive self-care and parenting/parent engagement support through the app and through a tele-wellness service, Ask a Nurse, provided by community health nurses at the Johns Hopkins School of Nursing. Children will have access to gamified learning materials in early literacy, math, social-emotional learning, and nutrition.