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 70 of 168Slavko Rogan
A crisis situation leads to changes in life. During December 2019, many people contracted pneumonia in the Chinese city of Wuhan. On January 7, 2020, the novel coronavirus (Covid-19) was identified as the cause of this disease. Within five months, the virus spread around the globe and forced countries to restrict public life. Due to the high infection rates in Europe, a lockdown followed between March and April 2020 (except in Sweden). As the number of infections decreased, European countries began to gradually relax the lockdown from May 2020. The lockdown and the later stages of loosening have an impact on lifestyle. Institutions of higher education must also adapt to this situation and have switched to distance learning. The University of Applied Sciences of Bern (BFH), Department of Health Professions with the Departments (DHP) of Nutrition and Dietetics and Physiotherapy, considers the question of the degree to which nutritional and exercise behavior has changed. The findings provide recommendations for future crises for students and employees of the BFH-DHP. In order to achieve this, at the BFH-DHP two anonymous online surveys will be conducted.
Erasme University Hospital
Fiberoptic bronchoscopy (FOB) is widely used as a diagnostic or therapeutic procedure in intensive care units. Patients with ARDS or COVID-19 disease often undergoes to these procedures. However, intensive care patients might suffer from serious side effects such as prolonged oxygen desaturation and adverse change in lung compliance and resistance. This study aims to evaluate these changes and determine their impact on patient stability.
E-ink corporation
Communication with patients on their clinical status is important in delivering care in the emergency department. During times of high volume or complex patients, there may be lapses in communicating with patients about their hospital course or plans of action. These miscommunications may be enhanced during the current COVID-19 pandemic as there is minimized in-person interaction with patients in order to conserve personal protective equipment and decrease the risk of disease transmission. This study utilizes a virtual white board to deliver updates to patients about the status of their emergency department stay.
The University of New South Wales
The healthcare industry is inherently demanding, stressful, and, at times, emotionally draining. On a typical day, many workers must make rapid and critical decisions, manage numerous demands, team conflicts, and challenging situations with patients and their families. For some health care workers (HCW), the current pandemic - COVID-19 - has also exacerbated these challenges. Providing psychological support is key in alleviating stress among HCWs, yet the situation does not require therapy because HCWs do not principally suffer from a mental disorder. RECHARGE was specifically developed for HCWs and is an abbreviated online version of Problem Management Plus, an evidence-based intervention that helps to cope with stress in times of crisis. As a brief psychological intervention for adults affected by adversity emerging from stress exposure, RECHARGE teaches people three well-documented strategies to manage acute stress (a: managing stress, b: managing worry, c: meaningful activity). It includes psychoeducation, arousal reduction techniques, managing worries and problem-solving skills, behavioral activation, and enhancement of meaningful activities, which are all based on the principles of cognitive-behavioral therapy. The aim of this study is to evaluate the efficacy of RECHARGE to reduce stress in HCWs and enhance their work performance. Participants in this randomized controlled trial (RCT) study are randomly assigned to either RECHARGE or the active control group. To this end, stress including symptoms of burnout, worries, anxiety, depression, PTSD, and work performance will be measured at baseline, post-intervention, and at a 2 and 6 month follow up.
Norwegian Institute of Public Health
Whether university teaching on campus with infection control measures in place is associated with higher risk of COVID-19 than online instruction, is unknown. The investigators will assess this by conducting repeated surveys among students at universities and university colleges in Norway, where some instruction is given in-person, and some is provided online (hybrid model). The investigators will ask about the students' COVID-19 status, and how much in-person and online instruction the students are getting. The investigators will estimate the association between in-person instruction and COVID-19-risk using multivariate regression, controlling for likely confounders. The investigators will also assess whether type of instruction is associated with how satisfied the students are with the instruction the students are offered, their quality of life, and learning outcomes.
Ohio State University
Covid-19 is an additional stressor Black women have to deal with that may interfere with hypertension self-care management. Social connectedness is a source of resilience for Black women to promote mental and physical health. Unfortunately, in the face of the Covid-19 pandemic, social distancing is a challenge further isolating Black women from their networks. How is social connectedness to manage stress and emotional well-being in a social-distancing society for Black women with hypertension? The research team proposed a synchronous web-based version of Enhanced Co-Created Health Education InterventioN (eCo-CHIN) that build the success and best practices derived from the original intervention. A Covid-19 session will be included as a way of helping Black women to maintain resilience and self-care during stressful times. The eCo-CHIN intervention is innovative and timely because the research team are using a synchronous platform preparing Black women on how to deal with Covid-19 while taking care of self. The primary investigator for this pilot study (Dr. Wright) is a Black Early Stage Investigator and former KL2 (career development) awardee. The interdisciplinary research team has the expertise and resources to deliver this Enhanced Co-CHIN intervention.
Lady Davis Institute
COVID-19 is having profound effects on older adults' due to social isolation measures which may negatively impact individuals' mental and physical health. Recently, a telephone program, the Telehealth Intervention Program for Older Adults (TIP-OA), was created. In this program, a volunteer is calling older adults (age≥60) every week to have a friendly conversation. The objective of this study is to evaluate the effectiveness of this telephone program (TIP-OA) in reducing stress, improving the mental health of program users, and understand their experiences.
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.
M.D. Anderson Cancer Center
This study investigates a new diagnostic test in detecting SARS-CoV-2, the virus that causes the disease COVID-19. This may help to improve testing for COVID-19.
ARCTEC
Dogs are some of nature's greatest detectives, owing to their incredible sense of smell and ability to be trained. Most of us will be familiar with seeing trained sniffer dogs at airports looking for drugs and other prohibited items, but their skills don't stop there. The use of medical detection dogs is becoming increasingly common, as they are able to identify cancers, changes in blood sugar levels and even predict seizures. These are just a few examples of dogs playing a key role in public health. Many diseases can alter the way humans smell. A study undertaken by the London School of Hygiene & Tropical Medicine (LSHTM) and Durham University has shown that dogs are able to accurately diagnose malaria. The investigators know that respiratory illnesses can alter your body odours, and thus the investigators plan to determine whether dogs are able to identify the novel coronavirus known as COVID-19 (or SARS-CoV-2). COVID-19 can present itself asymptomatically (i.e. causing no apparent symptoms), which could lead to the spread of infection in the population. The investigators believe that dogs may be able to identify asymptomatic patients, as well as those who have mild symptoms (symptoms not requiring treatment, hospital stay or limiting normal activities). It is thought that a single medical detection dog stationed within an airport would be able to screen up to 750 people for COVID-19 infection in just 1 hour, informing those who are infected to isolate, preventing further spread of the disease. In order to determine whether it is possible for dogs to accurately diagnose COVID-19, the investigators must first collect samples. NHS staff and members of their households that are eligible for SARS-CoV-2 screening, have been selected to participate in this study due to their potential exposure to this disease agent. In addition, participants from the general population who are displaying mild COVID-19 symptoms or have been exposed to COVID-19 will be recruited via hospitals, testing centers, outbreak testing programs and home testing programs. Initially, participants will attend their screening test as planned or confirm that they have had a swab test within the previous 24 hours. Immediately following this, the investigators will ask participants to collect samples of breath odour and body odour, which will be collected passively through the wearing of face masks, shirts, and nylon socks. The investigators will ask to be provided with the results of the SARS-CoV-2 screening swab, which will allow for us to determine whether participants are positive or negative for SARS-CoV-2. These odour samples will be grouped by positive or negative test results, and transported to LSHTM where these will be processed in order to prevent contact with the virus, negating the risk for dogs and their handlers. A pilot study will be undertaken to confirm whether dogs are able to distinguish between positive and negative samples using traditional sniffer dog training methods. If this is possible, the investigators will proceed to the main study to determine the accuracy (known as sensitivity and specificity) of the dogs' ability to identify the virus. Both the handler and the dogs themselves will be 'blinded' to the samples, and thus unaware of which sample is which. When the data generated by these tests is entered, it will be confirmed whether or not the samples have been correctly identified. The dogs will be trained to detect and report the detection of the volatile odours characteristic of COVID-19 infection. For quality control purposes the investigators also aim to characterise the COVID-19 odour profile by analysing samples with a special process called GC (gas chromatography) and/or GC-MS (gas chromatography coupled mass spectrometry). This will help to inform the identification of compounds showing differences between infected and non-infected samples. The investigators believe that this work could be useful in the fight against COVID-19.