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 190 of 202Imperial College London
In the United Kingdom, there are currently 138,000 confirmed patients with coronavirus, causing 18,738 deaths. Whilst the disease may be mild in the majority of patients, a significant proportion of patients require intensive care therapy and a ventilator due to lung injury. In addition to lung injury/failure (acute respiratory distress syndrome (ARDS)), around 50% of patients admitted to intensive care develop acute kidney injury (AKI) (requiring advanced support via haemofiltration) and multi-organ failure. It is unclear why patients suffering from COVID-19 develop such severe lung injury (requiring life support or ventilation) or indeed why patients develop other organ dysfunction such as kidney injury. The investigators hypothesis that this may due to an over-reaction of the immune system particularly in the lungs. This then results in the release of various mediators and biological messengers which can be pushed into the blood bloodstream (exacerbated by positive pressure generated by the ventilator). These mediators then travel, via the blood, to other organs such as the kidney where they cause inflammation and injury of cells, resulting in organ failure. The investigators would like to apply their well-established laboratory methods to further the scientific community's knowledge of this severe and deadly viral condition and we hope that this would lead to the development of medication that would treat this deadly virus.
Medialis Ltd.
Post Acute COVID-19 Quality of Life (PAC-19QoL) Tool Development and Patient Registry (PAC-19QoLReg)
Coronavirus Disease 2019 (COVID-19) is a newly emerged disease, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The COVID-19 pandemic is having a large impact on the mental and physical health of patients, yet data on the quality of life of post-COVID-19 patients is lacking. There are currently no post-COVID-19 specific measures for quality of life, particularly none which include the views of post-COVID-19 patients themselves. This observational study will recruit participants to contribute their preferences to the creation of a post-COVID-19 specific patient-reported measure on post-COVID-19 quality of life. Participants will be split into three groups: those who were not hospitalised; those who were hospitalised but not in intensive care units; and those who were hospitalised and in intensive care units. The creation of this measure will form phase 1 of the study, with 30-60 participants (10-20 in each group above) recruited to complete online surveys to find out their preferences of areas of life to include in such a measure. This will involve 3 online surveys, 1) to ask which areas of life they feel are impacted and how; 2) to find consensus about the areas to be included; 3) to weight the relevance of these areas in relation to each other. In phase 2 recruitment will open to additional participants and all participants will be asked to complete the finalised post-COVID-19 quality of life measure once a month for 12 months, aiming for a minimum of 100 participants at this stage. All participants will also be asked to complete a demographic questionnaire to inform the analysis of the data.
University Hospital, Bordeaux
The coronavirus disease 2019 (COVID-19) outbreak is now considered as a public health emergency of international concern by the World Health Organization. In the context of the health emergency, research on the pathogen (the SARS-CoV-2 coronavirus), the disease and the therapeutic care is being organized. Research projects require the use of biological samples. This study aims at setting up a collection of biological samples intended for application projects in any discipline. The main objective of the study is to collect, process and store biological samples from patients and caregivers infected with SARS-CoV-2 (COVID-19) at the biological ressources center of the Bordeaux University Hospital.
National Institutes of Health Clinical Center (CC)
Background: People who are recovering from COVID-19 may continue to have problems that affect their daily life. For instance, they might feel overly tired. Researchers want to learn if exercise can help people recover after COVID-19 infection. Objective: To study if participation in a rehabilitation exercise program can help people recovering from COVID-19. Eligibility: Adults ages 18-80 with a lab-confirmed SARS-CoV2 infection (the virus that causes COVID-19), and are still having some symptoms. Design: Participants will have a medical history and physical exam. They will give blood and urine samples. They will have tests to measure heart and lung function. Their blood vessels will be assessed. Participants will have a computed tomography scan of the body. They will have an ultrasound of the muscles in their arms, legs, and chest. Participants will take a 6-minute walk test. They will take other balance and movement tests. Participants will walk on a treadmill while hooked up to a monitor. Then they will be interviewed. It will be audio-recorded. Participants will complete surveys about their symptoms and daily activities. Participants will take a smell test. For this, they will identify different smells. They will also have memory, attention, and mental functioning tests. Participants will wear an activity monitor on their wrist 24 hours a day. They will exercise 3 times a week for 10 weeks by moving vigorously on a track or treadmill for 30 minutes. They will attend education classes once a week for 10 weeks. Participants will be contacted by phone or email every 3 months for 1 year after they complete the exercise part of the study. They will wear an activity monitor for up to 2 weeks.
NYU Langone Health
COVID-19 is associated with acute pulmonary and cardiac injury. To better understand the degree and severity of cardiopulmonary injury as well as short and long-term sequelae of COVID-19 infection, this study will perform longitudinal study in patients who had recent known diagnosis of COVID-19.
Emilia Falcone, MD
Sample Size: n=570 Accrual Ceiling: n=627 Study Population: Patients age 18 to 100 years The study duration includes 51 months to recruit patients and 24 months of total follow-up time counted from the first day of COVID-19 symptoms or date of confirmed COVID-19 diagnosis. Study Design: This is a prospective, observational cohort study to evaluate the short- and long-term end-organ complications of COVID-19 and to establish a COVID-19 biobank. Participant Cohorts: 1. Individuals who had previous asymptomatic or mild COVID-19 (mild=never required supplemental oxygen during the acute phase of the infection) 2. Individuals who had previous moderate or severe COVID-19 (moderate=required supplemental oxygen by nasal cannula during the acute phase of the infection; severe=required supplemental oxygen by either high-flow nasal cannula, non-invasive positive pressure ventilation or intubation) 3. Individuals who had COVID-19 but did not have signs or symptoms related to COVID-19 lasting beyond 4 weeks from the date of COVID-19 symptom-onset or diagnosis 4. Individuals who have not had COVID-19 (i.e. individuals who tested negative for COVID-19 and who never had symptoms consistent with COVID-19)
University of Malaga
The COVID-19 can cause important sequels in the respiratory system by bilateral pneumonia and frequently presents loss of strength, dyspnea, polyneuropathies and multi-organic affectation. Long COVID-19 has been defined as the condition occurring in individuals with a history of probable or confirmed SARS-CoV-2 infection, with related symptoms lasting at least 2 months and not explainable by an alternative diagnosis. The practice of digital physiotherapy presents itself as a promising complementary treatment method to standard physiotherapy, playing a key role in the recovery of function in subjects who have passed the disease and who maintain some symptomatology over time. The aims of this research are to explore the effect of a digital physiotherapy intervention on functional recovery in patients diagnosed with Long COVID-19 and to identify the level of adherence to the treatment carried out. Physiotherapy interventions acquires a fundamental role in the recovery of the functions and the quality of life. As secondary objectives, the aim is to identify the satisfaction and perception of patients with the intervention and the presence of barriers to its implementation (throught a qualitative research), as well as to evaluate the cost-effectiveness from the perspective of the health system. A quasi-experimental pre-post study assessed initially and at the end of the 4-week intervention the functional capacity (1-min STS and SPPB) and the adherence (software). The hypothesis of this research is that the implementation of a TR program presents positive results. If hypothesis is confirmed, that would be an opportunity to define new policies and interventions to address this disease and its consequences.
Centre Hospitalier Intercommunal Creteil
In early December 2019, cases of pneumonia of unknown origin were reported in Wuhan, Hubei Province in the People's Republic of China. The disease spreads rapidly and the number of sick people is increasing. On January 3, 2020 a new virus of the coronavirus family is identified in samples of bronchoalveolar lavage fluid from a patient in Wuhan and subsequently confirmed as the cause of these pneumonias. On 7 January 2020, the World Health Organization (WHO) designated it as the new coronavirus 2019 (i.e. 2019-nCoV). On 11 February 2020, the WHO designated the disease associated with 2019-nCoV as coronavirus 2019 disease (COVID-19). On 12 March, WHO announced that the COVID-19 outbreak is a pandemic. As of March 24, 2020, more than 375,000 cases of COVID-19 had been diagnosed with more than 16,000 deaths attributed to this virus. (Ref WHO https://www.who.int/emergencies/diseases/novel-coronavirus-2019 ). In France, the number of cases rose from 105 cases at the end of February to 19615 confirmed cases on March 24. (Source Public Health France). Most of the cases are adults. However, children are not completely spared and serious cases have been described. These severe cases can be respiratory or extra-respiratory (e.g. myocarditis). We also know that pediatric and adult cases differ in terms of clinical, biological and imaging findings, particularly chest CT scans. However, the description of paediatric pictures, especially severe forms and the involvement of children suffering from co-morbidities, remains poorly reported. Finally, the risk factors for serious cases in children remain largely unknown. This observatory aim to describe the clinical phenotypes of hospitalized pediatric patients with Covid19 in France, according to age groups. Moreover for a subgroup of patients, informations regarding the long covid will be reported.
University Hospital, Grenoble
The current project is a prospective, multicentric cohort study aiming at a multidisciplinary assessment (pulmonary, cardiometabolic, sleep and mental health) of the consequences of infection by SARS-CoV-2, 3 months after the diagnosis in order to better characterize these complications. 400 patients with a positive diagnosis of SARS-CoV-2 will be included in the study 3 months after their diagnosis: They will be followed at 6 months, 1 year, 3 years, and 5 years, as function of their after-effects discovered at 3 months and their evolution.
Hopital Foch
The aim of this study is to compare placental pathologies in patients with COVID 19 infection at the time of childbirth or a history of COVID 19 during pregnancy versus control patients