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 20 of 74Johns Hopkins University
Coronavirus disease (COVID-2019) is a devastating viral illness that originated in Wuhan China in late 2019 and there are nearly 2 million confirmed cases. The mortality rate is approximately 5% of reported cases and over half of patients that require mechanical ventilation for respiratory failure. As the disease continues to spread, strategies for reducing duration of ventilator support in patients with COVID-19 could significantly reduce morbidity and mortality of these individuals and future patients requiring this severely limited life-saving resource. Methods to improve gas exchange and to reduce the inflammatory response in COVID-19 are desperately needed to save lives. The ketogenic diet is a high fat, low carbohydrate, adequate-protein diet that promotes metabolic ketosis (ketone body production) through hepatic metabolism of fatty acids. High fat, low carbohydrate diets have been shown to reduce duration of ventilator support and partial pressure carbon dioxide in patients with acute respiratory failure. In addition, metabolic ketosis reduces systemic inflammation. This mechanism could be leveraged to halt the cytokine storm characteristic of COVID-19 infection. The hypothesis of this study is that the administration of a ketogenic diet will improve gas exchange, reduce inflammation, and duration of mechanical ventilation. The plan is to enroll 15 intubated patients with COVID 19 infection and administer a 4:1 ketogenic formula during their intubation.
Sanford Health
This is a prospective, double-blind, randomized, placebo-controlled study in two distinct cohorts to evaluate the efficacy and safety of hydroxychloroquine in the prevention of COVID-19 infection.
Assistance Publique - Hôpitaux de Paris
Hydroxychloroquine, a derivative of chloroquine (an antimalarial drug) with a weak immunosuppressive effect, is prescribed by some teams alone or in combination with azithromycin. No randomized controlled trials have demonstrated its efficacy, particularly in primary care in the early stages of the disease. However, currently available data suggest better efficacy if treatment is given early in the disease, before symptoms worsen. To date, the majority of COVID-19 patients treated in outpatient care, particularly in general practice, represent the majority of COVID-19 patients. It is essential to evaluate, in primary care, the efficacy and safety of hydroxychloroquine combined with azithromycin in Covid-19 patients in order to be able to implement this therapeutic strategy as soon as the first symptoms appear. We realize a randomized, controlled, open superiority trial, in 2 parallel groups (ratio 1:1).The main objective is to assess the efficacy of Hydroxychloroquine combined with azithromycin in COVID-19 patients in primary care, in add-on to standard of care, on unfavorable outcome defined by the onset of at least one of the following between D0 and D14: hospitalization, death or percutaneous O² saturation ≤ 92% in ambient air.
University of Malaya
The investigators plan to perform an observational study to evaluate the prevalence of burnout, depression and medical errors in a designated exclusive Covid-19 patients hospital in Malaysia, during the Covid-19 pandemic. In addition, the relationship between burnout and depression with medical errors will be assessed. The population studied will be the nurses working in the Intensive Care Unit, who are at higher risk due to the nature of their work at the frontlines of the pandemic.
University of Pittsburgh
Since the novel coronavirus, SARS-CoV-2, was first reported in the Hubei province of China in December 2019, the US has become an epicenter for the pandemic, accounting for more than 220,000 cases and 4,800 deaths (CDC). The rapid spread of the associated disease, COVID-19, has overwhelmed healthcare systems in spite of unprecedented measures to reduce contagion. The resulting uncertainty with regard to the duration and magnitude of the pandemic and limited availability of resources and treatment have been detrimental to the mental health of frontline healthcare providers (NIH). Preserving the psychological wellbeing of these individuals is paramount to mitigating the effect of COVID-19 and delivering optimal patient care. Of particularly grave concern is how professional and personal distress caused by the COVID-19 pandemic will affect provider burnout (Lai et al. JAMA Network Open 2020). Professional burnout, characterized by emotional exhaustion, career de-prioritization, and loss of self-efficacy, represents a significant threat to the US healthcare system (Shanafelt et al. Ann Surg 2010; Han et al. Annals of Internal Medicine 2019). While burnout has been described as a reaction to chronic work-related stress (Melamed et al. Psychol. Bull. 2006), individual factors such as anxiety increase susceptibility to burnout (Sun et al. J Occup Health 2012). Although data suggests that occupational stress might amplify risk of anxiety (DiGiacomo and Adamson J Allied Health 2001), we have yet to understand how intensified anxiety among frontline providers during global health crises contributes to burnout. Similarly, it is unknown whether factors such as perceived organizational support (POS), a key driver of job satisfaction and performance (Muse and Stamper, J Managerial Issues 2007), modify anxiety and burnout under these circumstances. We hypothesize that diminished POS in response to the COVID-19 pandemic is associated with burnout and that this relationship is mediated by an increase in providers' anxiety. Delineating this relationship is a critical first step in developing interventions that ease the mental health burden of this pandemic and future crises for healthcare providers.
Advancing a Healthier Wisconsin Endowment
This investigation is a randomized intervention trial that evaluates behavioral nudges (BN) to increase hand washing behavior and subsequently reduce COVID-19 spreading to a targeted high-risk patient population based in Wisconsin.
Fondation Lenval
The Coronavirus disease 2019 (COVID-19) is causing a global pandemic with high morbidity and mortality among adults and mainly the elderly. Children seem to be little or not affected by this infection. It is estimated that children could be asymptomatic or pauci-symptomatic carriers and thus be vectors of the disease. This is why measures to close schools and confine populations have been decreed in a large number of countries, including France. However, there are only a few data on the prevalence of COVID19 disease in children. The deconfinement strategy depends on data on the prevalence of the disease, especially in children. Investigators propose to evaluate the incidence of Covid-19 in preschool and elementary schools children in the city of Nice (South of France) during the pandemic period using a local prospective study of 914 children
The University of Queensland
This project is a randomised trial in order to determine if "gamification" can result in behaviour change for healthcare workers in the residential aged care setting. The app is for Age Care and care workers at the front line who are working to protect those most vulnerable to COVID-19. There are 2 groups in this trial on group will receive current and accurate information from an app. The other group will receives the app with the addition of a gamification competent, this will include rewarding experiences for staff doing safety behaviours and wellbeing behaviours. The purpose of the gamification is to create a calming and reassuring experience that injects positivity and joy where possible during this stressful time.
University of Utah
Acute respiratory distress syndrome (ARDS) is a major complication among patients with severe disease. In a report of 138 patients with COVID-19, 20% developed ARDS at a median of 8 days after the onset of symptoms, with 12.3% of patients requiring mechanical ventilation. Efficacious therapies are desperately needed. Supportive care combined with intermittent prone positioning may improve outcomes. Prone positioning (PP) of patients with severe ARDS (when combined with other lung-protective ventilation strategies) is associated with a significant mortality benefit. In addition, PP for >12 hours in severe ARDS is strongly recommended by clinical practice guidelines. The aim of this study is to compare the outcomes of prone positioning versus usual care positioning in non-intubated patients hospitalized for COVID-19.
University Ghent
Attention control for external information and cognitive control for internal information play a causal role in emotion regulation according to different theories and empirical research. Former research in the lab of the investigators has shown positive effects of an interactive attention control/interpretation training, in which participants learned to unscramble scrambled sentences ("life is my a party mess") in a positive way ("my life is a party") by getting eye-tracking feedback about attention for positive ("party") vs. negative information ("mess"). After the training, participants could better reinterpret negative photos in a positive way. Attention- and cognitive control mechanisms prior to negative stressors (proactive control) and after negative stressors (reactive control) seem to play a role in this. Moreover, research has shown that low perceived control and negative expectations about future emotion regulation skills results in lower proactive control and a higher need of reactive control. Based on this, the assumption can be made that the effects of attention control training - targeting reactive control - could benefit from adding techniques that affect proactive control (e.g. psycho-education). In the present study this is investigated by testing a new two weeks attention control training to see if this has a positive effect on stress related complaints, depressive symptoms and emotion regulation. Given that the current COVID-19 pandemic is perceived as very stressful by a lot of people, the training could help here. Participants between 18 to 65 years of age are recruited during this corona crisis. The attention control training is a new smartphone based application. Participants have to unscramble scrambled sentences into grammatically correct sentences. In the training condition, participants are asked to unscramble the scrambled sentences in a positive way. By swiping, participants can see part of the sentences. This gives the investigators an image about the processing of the sentences. This procedure allows to measure how long participants attend to positive and negative words. In the training condition participants get feedback about the duration they process positive and negative words. In the control group participants unscramble the sentences as fast as possible without feedback on emotional attention. Participants only get feedback about the speed at which sentences are unscrambled. Before and after the 10 training sessions, attention of the participants is measured to see the effects of the training. Questionnaires on depressive and anxiety complaints, emotion regulation strategies, well-being and stress are administered before and after the training. There is also a follow-up measure 2 months after the training. Both groups (training and control) watch a psycho-education video before the start of the training.