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 470 of 753National Scientific Center for Phthisiopulmonology of the Republic of Kazakhstan
Randomized, blind, placebo-controlled phase- i study and randomized, open phase phase-ii study of QAZCOVID-IN®- COVID-19 inactivated vaccine in healthy adult volunteers from 18 years old and elder
Queen Mary University of London
The current COVID-19 pandemic has affected more than 3 million people worldwide across more than 200 countries. In the United Kingdom alone, at the end of April, there were almost 160,000 confirmed cases with more than 20,000 deaths. This has undoubtedly had significant physical and economical impact on the public. Healthcare workers are at high risk of developing life-threatening infectious diseases with increased exposure to patients' blood and bodily fluids. As such, health care workers arguably experience heightened anxiety and are predisposed to greater negative psycho-social impact from the current COVID-19 pandemic. The aim of this study is to evaluate the physical and psychological impact of COVID-19 on healthcare workers. This will be performed in two phases. In phase 1, investigators will collect information to evaluate the current psychiatric symptom profile (in particular, screening for anxiety or depression related symptoms), alcohol use, sleep-related complaints and overall well-being among healthcare workers who participate in this survey (with a focus on junior doctors). In addition the association of these mental health and behavioural parameters with the prevalence of stressful occasions, such as long-hours, unpredictability of work / redeployment, availability of personal protection equipment and concerns regarding family/relationship and self will be assessed. In phase 2, investigators will then reassess for the development or progression of psychiatric symptoms, use of alcohol and other substances, behavioural or interpersonal relationship changes as well as physical well-being at 6 weeks and 4- months. Physical well-being is assessed through the presence of suspected or confirmed COVID-19 infection and absence from work. Specifically, investigators will study the impact of variable provision of personal protection equipment (supply and training), extended working hours, and concern for well-being of family members, on work morale and anxiety levels. Another aim is also study the longer term mental health consequences of the current pandemic on health care workers.
Hospices Civils de Lyon
COVID-19 lockdown presents particular challenges for people living with obesity. Indeed during this period, the lifestyle was deeply modified: diet, activity, and sleep behaviours, home office, take care of child, social distancing... All of these modifications may have led to stress and anxiety. It has been previously demonstrated that high perceived stress levels are correlated with high preference for sweet and fat foods . In this context caution would be exercised in obese patients especially those with binge eating disorders. Indeed binge eating disorder is characterized by compulsive overeating or consuming abnormal amounts of food while feeling unable to stop and a loss of control. And one key trigger of binge eating disorder is stress and anxiety. Thus, patients with binge eating disorders may have been more sensitive to the impact of lockdown and thus urgently would require appropriated care management. The main objective is to compare the eating behaviour between obese patients with or without binge eating disorders. The second objective is to compare the weight evolution between the two groups before and after the lockdown. To reach these objectives, the scientific team of the CIO project proposes to contact by phone and e-mail obese patients (with or without binge eating disorders) who have been hospitalized for their obesity disease before the start of the lockdown in the Endocrinology department of the Lyon Hospital. The patients will be asked to fill in several questionnaires (using an online tool) allowing to evaluate their mood, anxiety, eating behaviour, binge eating disorders… during the lockdown. The results of these questionnaires will be compared to those collected during their hospitalisation before the lockdown. The hypothesis is that participants suffering from binge eating disorder will have more sever eating behaviour perturbations as higher level of stress, anxiety, depressive symptoms.
Icahn School of Medicine at Mount Sinai
Mindfulness education will be provided via a virtual platform to see if staff stress can be decreased during this time of pandemic.
University of Nottingham
We have developed an online learning resource designed to support healthcare staff during and after the COVID-19 pandemic. This resource has been produced in anticipation of the psychological effect of working during this time. This is an open access, free, online resource available here: https://www.nottingham.ac.uk/toolkits/play_22794 It is designed to be relevant for healthcare staff, and we are evaluating it now with healthcare students as our next generation of healthcare staff. We are interested in knowing more about your views of healthcare students towards this package. This will help us to determine its value as a learning resource to support psychological wellbeing in healthcare students, alongside other welfare supports. The aim is to describe the views of healthcare students towards an e-learning package developed in response to COVID-19 on Psychological Wellbeing for Healthcare Workers.
University of Sao Paulo
The aim of this study is to assess the effect of a home-based exercise training during social isolation due to covid-19 pandemic in patients who undertook bariatric surgery.
Tychan Pte Ltd.
The emergence and rapid spread of the coronavirus disease 2019 (COVID-19) since December 2019 across 188 countries globally has become a major public health crisis. COVID-19 was declared a pandemic by the World Health Organisation (WHO) on the 11th March 2020. To date, more than 14,000,000 cases and 600,000 deaths have been reported. COVID-19 is an acute respiratory disease caused by the novel SARS-CoV-2 virus from the Betacoronavirus genus, just like SARS-CoV and MERS-CoV. SARS-CoV-2 is primarily transmitted person-to-person through respiratory droplets or close contact. Fomite transmission has also been implicated as a transmission route. Common respiratory symptoms such as fever, sore throat, cough and shortness of breath, may appear 2 - 14 days after exposure. About 20% of infected cases progress to severe disease resulting in an estimated 2 - 5% mortality reported. With the unrelenting increase in cases being reported worldwide, there is thus an urgent need for therapeutics to be developed and used to disrupt the ongoing pandemic. To date, there is no specific proven antiviral treatment for COVID-19. Supportive care is recommended for symptom relief and for severe cases, organ support is critical for optimal outcome. Numerous vaccine candidates against SARS-CoV-2 are under development and a couple have entered Phase 1 clinical trials. Remdesivir, a nucleotide analog, developed by Gilead Sciences as a treatment for Ebola virus disease is currently being repurposed and undergoing multiple clinical trials to evaluate safety and efficacy in COVID-19 patients. In a preliminary study, convalescent plasma containing neutralizing antibodies against SARS-CoV-2 has also been experimentally administered in critically ill COVID-19 patients with promising results. Donor plasma used was rich in virus specific IgG and IgM antibodies as determined by ELISA. Within days of convalescent plasma treatment, patients showed decrease in viral load (via qRT-PCR), as well as improved clinical status being observed. Tychan's TY027 will be the first biologics in the world, specifically targeting SARS-CoV-2, to enter human clinical trials. It is anticipated that a SARS-COV-2 specific monoclonal antibody therapeutic administered to acutely infected patients could reduce disease severity as well as prevent transmission by reducing viral load and viral shedding. It could also be used as prophylaxis against COVID-19 amongst high risk contacts.
University Hospital, Clermont-Ferrand
Impact of Covid-19 Restrictive Measure on Anxiety, Depression and PTSD for Relatives of ICU Patients
To limit the pandemic Covid-19 infection, the French government imposed a closure of all Intensive Care Unit (ICU). The family's visitations are prohibited during active Covid -19 pandemic in 2020 and in 2021. This restrictive visit policy could result in an increase in symptoms of anxiety, depression or post-traumatic stress disorder for relatives of ICU patients. The aim of this study is to compare symptoms of anxiety, depression or post-traumatic stress for relatives of ICU patients during Covid period with those during no Covid period (2020 and 2021) with those no Covid period (2022)
Clear Creek Bio, Inc.
This will be a phase 1a randomized, open label, multi-center study with approximately 24 subjects. All subjects will receive standard of care (SOC) per institutional guidelines for treatment of hospitalized patients with COVID-19 infection. In addition to SOC, the brequinar group will receive 5 daily doses of brequinar 100 mg.
University of Milano Bicocca
This is a prospective monocentric observational study with the aim of investigating the demographic and clinical factors related to the smell and taste disorders in patients with Severe Acute Respiratory Syndrome - Coronavirus - 2 (Sars-Cov-2) infection.