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 140 of 661Indiana University
The purpose of this study is to validate the use of a rapid, at home, point-of-care (POC) SARS-CoV-2 IgG antibody test in high risk healthcare workers. Additionally, we would like to evaluate the incidence of seroconversion in this high-risk population and to identify possible candidates for convalescent plasma donation for therapy/prophylaxis.
Insel Gruppe AG, University Hospital Bern
Background and Project Rationale: Degenerative aortic valve stenosis affects 2% of the elderly population aged 70 years or older and progresses insidiously with advancing age [1] before manifesting with symptoms such as decreased exercise tolerance, shortness of breath, chest pain and syncope on exertion. Without aortic valve replacement, the survival prognosis of patients with symptomatic aortic stenosis is poor. In the PARTNER 1B trial, all-cause mortality among 179 inoperable patients with severe symptomatic aortic stenosis allocated to conservative management amounted to 51% at one year [2]. Consistently, prospective registry data reported a mortality rate of 55% at 1 year in 78 patients with severe aortic stenosis undergoing conservative management [3]. The rapid spread of the SARS-CoV-2 pandemic represents an unprecedented challenge for healthcare systems. A limited number of ventilators and ICU beds call for a careful allocation of healthcare resources. On March 20 2020, the Federal Council prohibited elective interventions in all hospitals in Switzerland. Patients with untreated severe aortic stenosis are particularly vulnerable to SARS-CoV-2 infection [4] and face the dual risk of cardiac death from aortic stenosis on one side, and death from acute respiratory distress syndrome secondary to SARS-CoV-2 infection on the other. While the balance between the two risks is a matter of clinical judgement, the investigators established an algorithm for the management of patients with severe aortic stenosis during the SARS-CoV-2 pandemic. Patients with aortic stenosis deemed critical will undergo valvular replacement in spite of the ongoing pandemic while patients with severe but not critical aortic stenosis will undergo deferred intervention once the number of new SARS-CoV-2 infections flattens. In the current situation, aortic valve replacement in patients with severe, non-critical aortic stenosis will be deferred in order to give priority to SARS-CoV-2 patients. This unique situation allows the investigators to study the effect of deferral of aortic valve replacement in patients with severe aortic stenosis. The study is an amendment to the Swiss-TAVI registry. In contrast to the Swiss-TAVI registry, patients are not enrolled at the time of aortic valve replacement, but already at the time of referral for aortic valve replacement. Primary Objective: The aim of the present observational study is to explore the effect of deferral of valvular replacement in patients with severe but not critical aortic stenosis on morbidity and mortality. The primary objective is to describe rates of morbidity and mortality among patients with severe but not critical aortic stenosis in the interval from referral/indication for valvular replacement to intervention. Project Design: The study is a prospective cohort study of patients with severe aortic stenosis referred for aortic valve replacement. All referrals for aortic valve replacement will be allocated to either "transcatheter aortic valve replacement (TAVR)/ surgical aortic valve replacement (SAVR) (standard of care)" or "deferred intervention" based on prespecified criteria. Patients with critical aortic stenosis as defined by an aortic valve area (AVA) 60 mmHg or a history of cardiac decompensation during the previous 3 months or clinical symptoms on minimal exertion (NYHA III) will be allocated to TAVR or SAVR. All other patients with severe aortic stenosis defined by an AVA
Weprom
A coronavirus pandemic began on 12/31/2020 with the first Chinese patient. As of 3/16/2020, the epidemic affects more than 100 countries with 169,000 official infections and 6,500 deaths. This virus causes a pathology ranging from simple flu symptoms in 80% of cases to acute respiratory distress syndromes requiring resuscitation in 5% of cases and a death rate of 1.4 to 4% of cases. The arrival in France on 02/25/2020 with an exponential development of the infection (more than 5,000 cases on 03/15/2020) was accompanied by an unprecedented number of calls to the French emergency service call number (15) of worried patients with overload and sometimes saturation of the service that can impact calls and the care of patients really recovering from an emergency. We previously developed a Moovcare® web application which showed a 7 months survival benefit by early detection of relapsed lung cancer based on the reporting of patient symptoms analyzed by a validated algorithm in 300 patients and 1 trial randomized. Another application for detecting and monitoring chemo-induced febrile aplasia appears to show a reduction in the number of hospitalizations for sepsis. Finally, Smokecheck, a self-assessment application for symptoms by smokers, has shown that it improves the detection of symptomatic operable bronchial cancers (9 to 24%, p = 0.04). The web application https://www.maladiecoronavirus.fr/ was developed with a group of physicians from the Institut Pasteur, Hospitals group of Paris, Hospitals of Lille and Rennes and the ILC Jean Bernard in Le Mans. It makes it possible to guide symptomatic patients and patients who wishing to know what to do (call their general practitioner, teleconsultation, or call emergency service) based on symptoms and predictive factors of severity. Following the availability of this new tool, we want to assess the impact of the application on the number and relevance of calls to emergency service.
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.
Hospices Civils de Lyon
Covid-SER is a prospective multi-center study for the evaluation of diagnostic performance of available serological tests
Mayo Clinic
The purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis.
Henry Ford Health System
This is a prospective, multi-site study designed to evaluate whether the use of hydroxychloroquine in healthcare workers (HCW), Nursing Home Workers (NHW), first responders (FR), and Detroit Department of Transportation bus drivers (DDOT) in SE, Michigan, can prevent the acquisition, symptoms and clinical COVID-19 infection The primary objective of this study is to determine whether the use of daily or weekly oral hydroxychloroquine (HCQ) therapy will prevent SARS-CoV-2 infection and COVID-19 viremia and clinical COVID-19 infection healthcare workers (HCW) and first responders (FR) (EMS, Fire, Police, bus drivers) in Southeast Michigan. Preventing COVID-19 transmission to HCW, FR, and Detroit Department of Transportation (DDOT) bus drivers is a critical step in preserving the health care and first responder force, the prevention of COVID-19 transmission in health care facilities, with the potential to preserve thousands of lives in addition to sustaining health care systems and civil services both nationally and globally. If efficacious, further studies on the use of hydroxychloroquine to prevent COVID-19 in the general population could be undertaken, with a potential impact on hundreds of thousands of lives.