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 40 of 236The 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.
Athersys, Inc
Multicenter investigation featuring an open-label lead-in followed by a double blinded, randomized, placebo-controlled Phase 2/3 part to evaluate the safety and efficacy of MultiStem therapy in subjects with moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to pathogens including 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.
Apices Soluciones S.L.
The disease caused by the SARS-CoV-2 virus is a viral disease that infects the lungs, producing flu-like symptoms. Elderly infected patients and/or those with co-morbidities may suffer from acute respiratory distress syndrome due to pneumonia (COVID-19 disease). Given the high transmission, this virus has spread in recent months from Wuhan (China) to the whole world, becoming a global emergency pandemic. The lack of curative treatment for this disease justifies the need to carry out clinical trials that provide quality evidence on treatment options. Given the pathophysiology of the disease, which involves an uncontrolled inflammatory response of alveolar cells, a treatment that attenuates the cytokine cascade could be key in rescuing the patient's lung tissue. Mesenchymal cells, due to their immunoregulatory potential and regenerative capacity, can be an effective treatment for patients infected with the SARS-CoV-2 virus. In the present study we propose a therapy with undifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue, a treatment whose safety has already been described in other clinical trials and that shows promising results in pilot studies carried out in China.
University Hospital Tuebingen
In this study (i) the host genome to identify susceptibility regions of infection, inflammation, and host defense, (ii) host response to Severe Acute Respiratory Syndrome-Corona-Virus-2 (SARS-CoV-2) infection, and (iii) viral sequence composition to define viral sequences which may be correlated with disease severity in addition to the metagenome of the throat swab will be analysed .
Centre Hospitalier Intercommunal Creteil
Biological collection (blood sample) associated with clinical data from Covid-19 patients
Instituto Nacional de Perinatologia
The etiological agent of the current pandemic is a (+)ssRNA virus. SARS-CoV-2 is infecting thousands of people in the world with a fatality rate that varies from 0.1 to 5% in affected countries, thereby causing enormous economic losses. Few antibiotics have shown any efficacy in their combat, but have not yet proven adequate to stop the spread of the disease, nor are there any approved vaccines at the moment. From experiments in plants ongoing infections by RNA viruses, using thermotherapy, which is the application of heat at a temperature between 35-43 °C, the investigators know that raising the temperature affects the transcription of viral proteins due to the formation of small RNA molecules that interrupt the replication process by grouping in specific regions of the RNA molecule, preventing and inhibiting transcription. These small molecules are called small interfering RNAs (siRNAs). This feature has been used through thermotherapy in humans to combat the rapid replication of cells (i.e. cancer cells), attack cells infected by RNA viruses, and in the treatment of some parasitic infections.There are various commercially available devices for thermotherapy use in humans; they are mainly being used to ease muscle pain. They work by increasing the temperature in the range recommended for thermotherapy in humans 39-43 ° C. Therefore, the investigators consider this treatment modality can be used to aid in the elimination of SARS-CoV-2 from the human body, decreasing viral load, which could allow the immune system time for its control and elimination.
Centre Hospitalier Universitaire de Saint Etienne
Chronic fatigue is the most common and debilitating symptom in intensive care unit (ICU) survivors. Indeed, it has been widely reported that patients who stayed in ICU for prolonged periods report a feeling of tiredness for months to years after ICU discharge. This symptom seems particularly pronounced in Covid-19 patients and may affect their quality of life by decreasing their capacity to perform simple tasks of daily life. The aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in the feeling of fatigue of Covid-19 patients. Because the causes of this feeling are multi-dimensional, a large battery of tests will allow us to better understand the origin of chronic fatigue. A better knowledge of chronic fatigue etiology and its recovery will allow to optimize rehabilitation treatments to shorten the persistence of chronic fatigue and in fine improve life quality.
Swiss National Science Foundation
Mental health disorders are common during pregnancy and the postnatal period, and can have serious adverse effects on the well-being of woman and child. Every tenth woman has depressive symptoms and 5% suffer major depression during pregnancy. The consequences for global mental health due to the novel coronavirus disease, COVID-19, are likely to be significant and may have long-term impact on the global burden of disease. Pregnant women may be particularly vulnerable due to partial immune suppression. Besides physical vulnerability, the women could be at increased risk of mental health problems, such as anxiety, depression, and post-traumatic stress disorder (PTSD), due to social distancing leading to less support from the family and friends, and in some cases, partners not being allowed to be present during prenatal visits, labor and delivery. Furthermore, many pregnant women may feel insecure and worried about the effect of COVID-19 on their unborn child, if the women get infected during pregnancy. Today, young urban women are used to utilizing internet services frequently and efficiently. Therefore, providing mental health support to pregnant women via web-based support may be effective in ameliorating their anxiety/depression and reduce the risk of serious mental health disorders leading to improved maternal and perinatal outcomes.