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 100 of 149Shanghai Public Health Clinical Center
This randomized, double-blind, placebo-controlled, single-dose escalation trial will be conducted to evaluate the safety, tolerability, immunogenicity, pharmacokinetic and pharmacodynamic characteristics of a single dose of MW33 injection at different doses given to healthy subjects to provide a basis for exploration of the therapeutic and preventive effects of MW33 against neocoronavirus in human.
Hvidovre University Hospital
Most research on the coronavirus SARS-CoV-2 and COVID-19 disease relate to screening measures, development of vaccines and optimising treatment of hospitalised patients. It is likely that this pandemic will be ongoing for several years until a high level of immunity is reached in the population or a vaccine has been developed. Thus, there is a need of measures to help the SARS-CoV-2 infected individual at home to overcome the course of disease with less symptoms and strain. A Positive Expiratory Pressure (PEP) flute is feasible for home use and it is possible that regular use of PEP flute may prevent the progression of respiratory symptoms in non-hospitalized individuals with COVID-19 disease. The primary objective of the study is to examine the effect of PEP flute use among SARS-CoV-2 infected, non-hospitalized patients on self-reported change in COPD Assessment Test (CAT) score during 30 days of follow-up. The secondary objectives are to compare the development in hospitalization rates and use of antibiotics in the intervention group and the control group during the follow-up period.
Limbix Health, Inc.
Over 3 million teenagers in the USA have depression, and rates of depression and suicide are sharply increasing. Teenage depression has far-reaching consequences including impairments in academic and work performance and social and family relationships, substance abuse, and worsening of other health conditions, which can persist into adulthood. Access to mental health care for teenagers is limited due to a shortage of mental health providers and many teenagers and parents are reluctant to take antidepressants. COVID-19 and mandated physical and social distancing is expected to increase rates of teenage depression, and further limit access to traditional methods of care (e.g. psychotherapy). This highlights an urgent need to develop accessible, digital treatments for teenage depression to address the serious mental health impacts of the COVID-19 pandemic. This fully virtual study (https://www.limbix.com/spark) will compare the relative safety, effectiveness, and engagement of a mobile application based on cognitive behavioral therapy and behavioral activation (Limbix Spark), focusing on the idea that engaging in behaviors that are rewarding or provide a sense of mastery can be effective in reducing symptoms of depression. Limbix Spark will be compared to a mobile app containing educational material about depression (Psychoeducation).
Dr David DE BELS
A) Comparing the % of change in each clearances of pro-, and anti-inflammatory mediators (cytokine, chemokines and complement) in the COVID-19 patients treated with CytoSorb as compared to the same patient population who do not receive blood purification treatment. B) Testing the Cytokinetic model by measuring cytokines in the blood stream and in the BAL to see if you can create a reverse gradient allowing a massive passage of leucocyte from the blood toward the infected lungs.
Direction Centrale du Service de Santé des Armées
Stress is underpinned by a biological reaction of the organism allowing the production of energy to respond to a change in the environment (or stressor). Stress reaction is expressed in behavioural, cognitive, emotional and physiological terms. This biological response is non-specific because it is the same regardless of the stressor. Its evolution over time has been conceptualised by Hans Selye (1956) in the General Adaptation Syndrome (GAS) which comprises three successive phases. (i) The first phase, known as the alarm phase, corresponds to the activation of all biological mechanisms according to a trend regulation, allowing a rapid response to the stressor. (ii) The second phase of resistance which adjusts the stress response to the intensity of the perceived aggression according to a constant regulation. (iii) When the aggression disappears, a recovery phase dominated by the return of the parasympathetic brake allows a return to homeostasis (eustress). The "primum movens" of all pathologies is therefore the inability of the individual to adapt his stress response in duration and/or intensity to the course of the phases of the GAS (distress). The perception of not being in control of the situation contributes to the perceived stress and constitutes a well-established risk of distress. It is a risk factor for the emergence of burnout. It induces a biological cost called allostatic cost. Allostasis is a concept that characterizes the process of restoring homeostasis in the presence of a physiological challenge. The term "allostasis" means "achieving stability through change", and refers in part to the process of increasing sympathetic activity and corticotropic axis to promote adaptation and restore homeostasis. Allostasis works well when allostasis systems are initiated when needed and turned off when they are no longer required. Restoring homeostasis involves effective functioning of the parasympathetic system. However, when the allostasis systems remain active, such as during chronic stress, they can cause tissue burnout and accelerate pathophysiological processes. The perception of uncontrollability depends on the stress situation, the psychological and physiological characteristics of the subject and his or her technical skills in responding to the stressors of the situation. In particular, subjects with a high level of mindfulness are more accepting of uncontrollability and less likely to activate the stress response. The COVID-19 pandemic situation is a situation characterized by many uncertainties about the individual, family and work environment and the risk of COVID infection. Healthcare workers, like the military, are high-risk occupations that are particularly exposed to these uncertainties in the course of their work and continue to work in an uncertain situation. These professionals are described as a population at risk of occupational/operational burnout that the level of burnout operationalises. This ancillary study in a population of civilian and military non-healthcare workers will complement the study conducted among military health care workers. It will make it possible to isolate the specificity of each profession (civilian or military, healthcare personnel or not) with regard to the risk of burnout in the COVID context. The objective of this project is to evaluate the impact of the perception of non-control in the operational burnout of experts in their field of practice and to study the psychological and physiological mechanisms mediating the relationship between the subject's characteristics, perceived non-control and burnout.
Hopital Foch
In the context of the actual pandemia of the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which requires a better diagnostic strategy for the management of patients. The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. The analysis of VOC can be done either by the technique of the mass spectrometry which allows the identification of each VOC in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOC without identifying them. The VOC have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases. Moreover, it has recently been shown that properly trained dogs would be able to detect an olfactory signature of SARS-CoV-2 infection with a specificity greater than 90%; this olfactory signature corresponds to VOCs detectable by the flair of dogs (Nosaïs-Covid19 study). Validation of the diagnostic value of VOC analyzes by non-invasive and rapid methods (electronic nose analysis or mass spectrometry; detection by the scent of dogs) for the rapid detection and early diagnosis of a SARS-CoV-2 infection warrants the performance of this clinical study.
Beyond Air Inc.
The purpose of this multi center, open label, randomized, study is to obtain information on the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with viral pneumonia
Direction Centrale du Service de Santé des Armées
There are several clinical presentations of SARS-CoV-2 infection. Among the severe forms, pulmonary involvement with respiratory failure is common. Although severe lung involvement with SARS-CoV-2 meets the Berlin criteria for Acute Respiratory Distress Syndrome (ARDS), it differs from classic ARDS in that compliance (reflecting distensibility of the lung parenchyma) is frequently preserved. If the interest of Electrical Impedance Tomography has been demonstrated in classical ARDS, this is not the case in ARDS with COVID-19. However, the use of this technique in this particular patient population would make it possible to distinguish patients with severe hypoxemia linked to derecruitment from those without derecruitment, in whom hypoxemia is more likely to be linked to the loss of hypoxic vasoconstriction.
University Hospital, Basel, Switzerland
This study is to analyse the efficacy of LD-RT for treatment of Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2).
Escola Superior de Ciencias da Saude
This study aims to investigate whether adjunctive inspiratory muscle training (IMT) can enhance the benefits of pulmonary rehabilitation (PR) in patients with COVID-19. 120 patients will be randomized into an interventional group (PR plus IMT) and a control group (sham IMT plus PR). Improvement in quality of life, peak VO2 and VE/VCO2 slope will be defined as a primary outcome. Maximal inspiratory pressure, inspiratory muscle endurance, pulmonary function testing, severity of fatigue, cost-effectiveness and six minute walk test will be defined as the secondary outcomes.