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 250 of 556Hull University Teaching Hospitals NHS Trust
Since initial reports of a novel coronavirus emerged from Hubei province, China, the world has been engulfed by a pandemic with over 3 million cases and 225,000 deaths by 30th April 2020. Health care systems around the world have struggled to cope with the number of patients presenting with COVID-19 (the disease caused by the SARS-CoV-2 virus). Although the majority of people infected with the virus have a mild disease, around 20% experience a more severe illness leading to hospital admission and sometimes require treatment in intensive care. People that survive severe COVID-19 are likely to have persistent health problems that would benefit from rehabilitation. Pulmonary rehabilitation (PR) is a multidisciplinary program which is designed to improve physical and social performance and is typically provided for people with chronic lung conditions. PR courses typically last 6-12 weeks with patients attending classes once or twice weekly and consist of exercise and education components. PR is known to improve symptoms (e.g. breathlessness), quality of life and ability to exercise in those with lung conditions. Breathlessness is a very common symptom reported by people presenting to hospital with COVID-19 and loss of physical fitness will be very common. Using existing pulmonary rehabilitation programmes as a model, we have developed a tele-rehabilitation programme (a programme that will be delivered using video link to overcome the challenges faced by social distancing and shielding advice) for people that have been critically ill with COVID-19. In order to prove whether people benefit from this tele-rehabilitation programme after being admitted to hospital following COVID-19 we would need to perform a large clinical trial. However, before doing this it is important for us to answer some key questions: - How many people that have been admitted to hospital and needed intensive care treatment for COVID-19 still report breathlessness, fatigue, cough and limitation of activities after being discharged from hospital? - Is it possible to recruit these people to a trial of tele-rehabilitation after hospital discharge? - Are people willing and able to perform tele-rehabilitation in their own home using video-link to connect with their therapist? - Are there other rehabilitation needs that are commonly encountered by people requiring intensive care treatment for COVID-19 that could be addressed by tele-rehabilitation that the programme doesn't currently address? Investigators will perform a small study called a feasibility trial to answer these questions and gather some early information about possible benefits of tele-rehabilitation. Based on our understanding of other similar diseases, doctors and therapists think that people will benefit from rehabilitation after COVID-19. The investigators therefore want to test a trial design that makes sure that everyone gets the treatment. This type of trial is called a feasibility, wait-list design randomised controlled trial. People with breathlessness and some limitation of activities will be selected at random to receive tele-rehabilitation within 2 weeks or to wait 6-8 weeks before starting. how many people were eligible to take part, how many agreed to take part and the symptoms and rehabilitation needs that they have will be assessed. Investigators will then monitor symptoms and ability to exercise at the start and end of the trial and before and after tele-rehabilitation.
Imperial College London
Coronavirus Disease 2019 (COVID-19) has been widespread worldwide since December 2019. It is highly contagious, and severe cases can lead to acute respiratory distress or multiple organ failure. On 11 March 2020, the WHO made the assessment that COVID-19 can be characterised as a pandemic. With the development of machine learning, deep learning based artificial intelligence (AI) technology has demonstrated tremendous success in the field of medical data analysis due to its capacity of extracting rich features from imaging and complex clinical datasets. In this study, we aim to use clinical data collected as part of routine clinical care (heart tracings, X-rays and CT scans) to train artificial intelligence and machine learning algorithms, to accurately predict the course of disease in patients with Covid-19 infection, using these datasets.
University of California, Los Angeles
This is an open-label unblinded, randomized study to treat hospitalized covid-19 patients with colchicine plus current care (per institution treating physicians) vs. current care per institution treating physicians alone (the control arm)
Amazon Web Services (AWS) Canada
The VOICE-COVID study will evaluate the concordance of screening for symptoms of COVID-19 using a voice based device (Amazon Alexa) compared to manual screening by a study coordinator for individuals entering the Cardiology/Heart Failure clinic at the McGill University Health Centre.
Västmanland County Council, Sweden
This research study is designed to investigate the effects of a brief psychological intervention for improving depressed mood in older individuals (65 years and older) in isolation during the Coronavirus (COVID-19) pandemic. The treatment is delivered by telephone and consists of four weekly individual sessions. Two therapeutic methods are used in combination during this intervention: Behavioral activation (BA) and Mental Imagery (MI). BA involves identifying and scheduling enjoyable and meaningful activities to improve mood and reduce social isolation. To enhance BA efficacy and adherence, MI is paired with BA as MI is known to activate emotion and motivation. The MI intervention in this study involves having participants imagine, in vivid sensory detail, engaging in some of the activities that are scheduled during BA. Approximately 154 individuals will participate in the study. Half of the participants will be randomised to start the intervention immediately, while the other half of the participants will be randomized to a control group receiving the intervention after 4 weeks. This procedure makes it possible to evaluate the effects of the treatment while not disadvantaging participants randomized to the control group. Participants will be asked to fill in questionnaires before, during (at the end of each intervention week), and after treatment (or waiting period for the control group). Questionnaires will also be sent 1-, 3- and 6 months after treatment to follow up on the results. A smaller group of participants (10-15) will be asked to participate in a more detailed interview about how they experienced the treatment.
Hospital Galdakao-Usansolo
1. Objectives: 1.-To create risk stratification scales of poor evolution in patients infected by SARS-CoV-2. 2.-Evaluate the accessibility and equity that these patients have had in the different care processes, diagnostic and therapeutic procedures, with special interest in patients who came from residences, by age, gender or geographic origin.3.-Evaluate the effectiveness of different therapeutic schemes that have been used in this pandemic. 4.-Evaluate the effectiveness of different diagnostic tests used to predict the poor evolution of these patients 5.- Evaluate the real costs associated with the treatment of hospitalized patients with COVID-19 ; 2. Methods: Information will be recorded from electronic medical record: epidemiological data, onset of symptoms, comorbidities and their treatments, symptoms, analytical data, vital signs, tests performed, treatments during admission and evolution up to 3 months after discharge. Statistical analysis: The investigators will use classic survival models, logistic regression, generalized linear models and also analysis using artificial intelligence techniques . Health care costs are assessed. Applications for decision making will be derived as a product.
INSERM, Epopé team
The purpose of this study is to characterize the incidence and clinical features of the maternal COVID 19 infection, as well as the associated morbidity of the mother and the child, in the French context
University of Manchester
The current COVID-19 pandemic is a worldwide healthcare crisis. Of concern is the large number of patients that are/will require mechanical ventilation, and the associated strain that this will place on healthcare resources. At present, there are no specific therapeutic interventions directed at COVID-19 infection. However, observational data suggest that there is a subgroup of patients that demonstrate a hyperinflammatory response in response to COVID-19 and have a higher requirement for Critical Care and higher mortality. There is a strong case for the use of the naturally occurring anti-inflammatory cytokine interleukin-1 receptor antagonist (IL-1Ra) in these patients. Anakinra is a recombinant form of IL-1Ra that is licensed for clinical use. Success of use of anakinra in COVID-19 trials will be greatly enhanced by robust scientific evidence and established pharmacokinetics which inform the most effective dosing regimens. The latter is especially important when, as in the case of anakinra, drug supplies are limited, the drug has short half-life and clinical ease of application is critical.
Children's Hospital Colorado
The FDA has approved the CipherOx CRI T1 Tablet for use in subjects aged 19-36, and that this study aims to evaluate the device in subjects aged outside of this range and is being used off label. The FDA determined the Cipher OX CRI T1 Tablet to be a class II device in 2016, and additional research has been done since the FDA determination to further support the use of the device outside of its current labeling.
Ashvattha Therapeutics, Inc.
The primary purpose of Stage-I of this study is to evaluate the safety and tolerability of OP-101 in patients with severe COVID-19 and of Stage 2 of this study is to evaluate the efficacy of OP-101 in patients with severe COVID-19. The secondary purpose of Stage 1 and Stage 2 of this study is to determine the effect of OP-101 reducing proinflammatory cytokines biomarkers in severe COVID-19 Patients. A further secondary objective of Stage 2 of this study is: To evaluate the safety and tolerability of OP-101 in patients with severe COVID-19.