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 160 of 340Harvard Medical School (HMS and HSDM)
The study evaluates the effectiveness of yoga practices on reducing stress, negative emotion, anxiety, and depression and on increasing positive emotion, wellbeing and resilience. The study uses randomized wait-list control. All U.S. undergraduate students in 4-year universities and colleges age 18 or older are eligible to participate.
Modum Bad
The present study seeks to investigate the levels of parental burnout in the general parental population during the COVID-19 pandemic. Parental burnout is measured three months following (T2) the initiated viral mitigation protocols in Norway, a period where schools and kindergartens were closed, involving a period of home isolation for parents with their children. The burden of parents during this period is thought to have increased, as they were expected to conduct their own work virtually where possible, while at the same time acting as teachers for their children. The study aims to investigate the level of burnout among parents after months of viral mitigation strategies involved in the pandemic, in addition to predictors of parental burnout measured at (T1) are associated with parental burnout after three months (T2). Hypothesis and research question: Research Question 1: What is the level of parental burnout in the general parental population three months following initiated viral mitigation protocols (i.e., physical distancing) as compared to other similar pre-pandemic samples? Hypothesis 1: Parental burnout will be higher in the present sample three months into the pandemic as compared to similar pre-pandemic samples in similar populations. Hypothesis 2: Levels of parental stress, parental satisfaction, general self-efficacy, positive metacognitions, negative metacognitions, unhelpful coping strategies, marital quality and insomnia, all at T2 will significantly predict levels of parental burnout at T2. Exploratory: Do the predictors parental stress, parental satisfaction, general self-efficacy, positive metacognitions, negative metacognitions, unhelpful coping strategies, all at baseline (T1), predict parental burnout at T2, beyond and above these same aforementioned predictors at T2 and pre-existing mental health condition, age, gender, and education? Exploratory: Levels of parental burnout will be explored across subgroups in the sample.
Modum Bad
Study description: The present study seeks to investigate the predictors and maintaining mechanisms of depression and anxiety symptoms during the COVID-19 pandemic, exactly 3 months following the strictest viral mitigation strategies initiated in Norway in response to the pandemic. This is the time period where the major pandemic protocols are lifted in Norway, following three months of strict pandemic mitigation protocols. The study further aims to identify subgroups with highest levels of depressive and anxiety symptoms during the measurement period, to identify vulnerable subgroups with maintained symptoms three months following the pandemic. Hypotheses and research questions: Research Question 1: What is the level of depressive and anxiety symptoms three months following the employment of the strict viral mitigation protocols (i.e., physical distancing protocols) in the general adult population? What are the proportion above the validated cut-offs for depression and general anxiety? Hypothesis 1: There will be a significant decrease in the levels of depression and anxiety symptoms from the baseline (T1) with the strictest mitigation protocols to measurement the measurement period three months into pandemic (T2) where major pandemic mitigation protocols are lifted. Additionally, there will be a significant decrease in the proportion of the sample meeting validated cut-offs for depression and anxiety from T1 to T2. Hypothesis 2: Higher level at T1 and less reduction from T1 to T2 in positive metacognitions, negative metacognitions, and unhelpful coping strategies all measured with CAS-1, will be related to less reduction in depression and anxiety, above and beyond age, gender, and education. Higher level at T1 and increases from T1 to T2 in physical activity and perceived competence will be related to greater reduction in depression and anxiety, above and beyond, age, gender, and education. Exploratory: The investigators will further explore the proportion showing reliable change in depression and anxiety and investigate the differences in changes in depression and anxiety across different demographic subgroups in the sample
University Hospital, Caen
Since the description of the first cases of infection in December 2019 in the Hubei province in China, a new coronavirus, called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), emerged and caused a pandemic. This new virus is responsible for an infectious disease with respiratory and potent severe symptoms, called COVID-19 (coronavirus disease 2019). The first data concerned essentially the adult population and gave a clinical description of the disease. However, data is missing in the pediatric population. The first published studies indicate that children seem to have a lower risk to get a severe form of COVID-19. Except the case of a child with leukemia recently described with the diagnosis of COVID-19, there is currently no data about pediatric patients with an oncology history or under chemotherapeutic drugs. Cancers are rare among children and is estimated to concern about 1700 new cases in a year in France. Malignant tumor or its treatment can affect self-immunity, which could favor SARS-CoV-2 infection or its aggravation. Thus, the investigators propose in this study to collect data about French children with a cancer and diagnosed with COVID-19.The analysis of the collected data will refine clinical characteristics of SARS-CoV-2 infection in this population. It will be critical for elaborating recommendations for the management of COVID-19 in children with cancer.
Yale University
In times of pandemics, social distancing, isolation and quarantine exacerbate depression and anxiety as confined people are detached from their loved ones, deprived of personal liberties, and devoid of purpose owing to altered routine and livelihood (1,2). Those with pre-existing mental health problems or illnesses (MHPIs) might suffer from limiting interpersonal interactions that are central to their self-management, as well as reduced access to helpful but "non-essential" (often cancelled) psychiatric services (3). In response to this situation, this feasibility study of a trial consists of offering a transitional measure of online peer support for people suffering from (a) psychotic disorders or (b) anxiety and mood disorders, and to determine an effect size to this Peer Support Workers-delivered intervention in terms of both personal-civic recovery and clinical recovery (4). Peer Support Workers (PSWs) are persons with first-hand lived experience of MHPIs, and who are further along in their own recovery journey. As recommended by recovery-oriented best practices guidelines (5,6), upon training and certification they can provide supportive services when hired to fill such a paid specialty position directly in, or in conjunction with, current psychiatric services. Indeed, recovery focuses on how individuals can have more active control over their lives (agency). It is characterized by a search for the person's strengths and capacities, satisfying and meaningful social roles, and mobilizing formal and informal support systems. Peer support has thus become one predominant concept in the recovery paradigm and PSWs are specialized in peer support. Yet, not much is known about the efficacy of PSWs from a consumer's perspective of personal-civic recovery. The five principal research questions are whether this online intervention will have an impact in terms of (Q1) personal-civic recovery potential and (Q2) clinical recovery potential, (Q3) how these potentials can be impacted by the COVID-19 pandemic, (Q4) how the lived experience of people in recovery can be mobilized to cope with such a situation, and (Q5) how sex and gender considerations can be taken into account for the pairing of PSWs with service users, beyond considerations based solely on psychiatric diagnoses or specific MHPIs.
Dr. Zaineb Akram
Since the outbreak of coronavirusdisease2019(COVID-19), many researchers in China have carried out/published clinical trials on treatment based on Western medicine, traditional Chinese medicine or a combination of the two. Trials on treatment modalities have mainly used antivirals, interferon, glucocorticoids in addition to traditional Chinese medicine. There are also clinical trials exploring hydroxyquinoline/chloroquine sulphate, immunoglobulins, Vitamin-C, washed microbiota, nebulized interferon, teicoplanin as well as Mesenchymal stem cells. However, most of these trials were small (median sample size 100) and the bulk of potential therapeutic strategies remain in the experimental phase and currently there is no effective specific antiviral with high-level evidence.The aim of this study is assess the efficacy of MSCs as an add-on therapy to standard supportive treatment for patients with moderate/severe COVID-19.
Jean Brown Bequest Fund, Glasgow, UK
Telemedicine will be used as standard practice during the Covid Pandemic, in order to reduce clinician exposure to patients and potential high viral load, and reduce patient footfall in a hospital caring for Covid patients. The 3D telemedicine uses multiple cameras in the clinic room which can reconstruct an image in 3 dimensions. This may give more information about a patient's condition, particularly in more visual specialties such as Plastic Surgery. The systems have hospital approval to be used for telemedicine, all equipment is CE marked. There are no data regarding the use of 3D telemedicine, but similar studies have been performed in many fields including orthopaedic surgery using 2D telemedicine (Buvik 2016). This study aims to provide non-clinical validations of the 3D telemedicine for usability, presence, satisfaction and reliability, using healthy volunteers only.
Hospices Civils de Lyon
The coronavirus outbreak is a stressful event for the whole population. Confinement measures are protective against the risk of dissemination of the virus, but they can also lead to several psychological symptoms. In children, a study in China has reported about 20% of depressive or anxious troubles in school-age children after a 4-week period of confinement. In France, confinement lasted about 8 weeks. School resumed on May 11th for primary school children and on June 2nd for secondary school children. In this survey, we aim at exploring the psychological status of these children and the impact on their schooling, for better understanding, support and prevention. Through this online questionnaire, we also aim at giving some psycho-education advices. Finally, we could identify some subgroups of children particularly vulnerable, and organise some specific support for them in coming months.
Royal Centre for Defence Medicine
This study is intended to address the association between vitamin D status and seroconversion to SARS-CoV-2 in healthy young adults. The primary aim of the study is to determine the rates of 'silent' seroconversion rates, consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population with a wide spread of vitamin D concentrations. The secondary aims of this study are to explore: 1. Any effect of vitamin D status on symptomatic illness. 2. The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults. 3. The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time. 4. Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/ complementary serological method 5. The effect (if any) of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs and iii) gender.
Medical University Innsbruck
The aim of this questionnaire survey is to evaluate the improvement in vision-related quality of life before and after cataract surgery using the National Eye Institute Visual Function Questionnaire 25 and the delay of improvement in the COVID-19 pandemic.