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 60 of 632National Cancer Institute (NCI)
This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.
Nakhle Saba, MD
I. Study Design: This is a single-arm feasibility study to assess the safety and efficacy of anti-SARS-CoV-2 convalescent plasma (CP) in 1. intubated, mechanically ventilated patients with confirmed COVID-19 pneumonia by chest X-ray or chest CT. 2. hospitalized patients with acute respiratory symptoms between 3 and 7 days after the onset of symptoms, with COVID-19. II. Study Population: 1. Population 1: Mechanically ventilated intubated COVID-19 patients aged 18 years or older. 2. Population 2: Hospitalized COVID-19 patients aged ≥18 years of age with respiratory symptoms within 3 to 7 days from the beginning of illness. III. Study Agent: SARS-CoV-2 convalescent plasma (1-2 units; ~200-400 mL at neutralization antibody titer >1:160.
University Hospital, Toulouse
A new coronavirus (COVID-19) highlighted at the end of 2019 in China is spreading across all continents. Most often at the origin of a mild infectious syndrome, associating benign symptoms (such as fever, cough, and headache) to different degrees, COVID-19 can cause serious pulmonary pathologies and sometimes death. Data on the consequences during pregnancy are limited. The first Chinese data published seem to show that the symptoms in pregnant women are the same as those of the general population. There are no cases of intrauterine maternal-fetal transmission, but cases of newborns infected early suggest that there could be vertical intrauterine, perpartum or neonatal transmission. Prematurity and cases of respiratory distress in newborns of infected mothers have been described. Subsequently, an in-depth analysis of cases in pregnant women and pregnancy issues are necessary in order to improve knowledge on the subject.
University Hospital, Toulouse
The effects of severe acute respiratory syndrome SARS-Cov-2 (Covid-19) on the myocardium and their role in the clinical course of infected patients are still unknown. Epidemiological studies report biological myocardial involvement in 10 to 25% of cases. The objective of this study is to cardiac phenotype using comprehensive cardiac imaging tools of patients infected with Covid 19 in order to explore the functional impact of the infection on the myocardium.
Centre Hospitalier de PAU
Emergence of Covid-19 virus is associated with high frequency of extremely severe clinical pictures, with minor signs of CNS impairment (e.g. anosmia, headache). Since neurotropism is a common feature of coronavirus infection in animals, the investigators examine if indirect signs of CNS lesion are observed in association with severe Covid-19 infection.
Ministry of Health, Malaysia
We 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. We also seek to assess the relationship between burnout and depression with medical errors. The population studied will be the anaesthesiology fraternity, who are at higher risk to the nature of their work at the frontlines of the pandemic.
National Cancer Institute (NCI)
This phase II expanded access trial will study how well tocilizumab works in reducing the serious symptoms including pneumonitis (severe acute respiratory distress) in patients with cancer and COVID-19. COVID-19 is caused by the SARS-CoV-2 virus. COVID-19 can be associated with an inflammatory response by the immune system which may also cause symptoms of COVID-19 to worsen. This inflammation may be called "cytokine storm," which can cause widespread problems in the body. Tocilizumab is a medicine designed to block the action of a protein called interleukin-6 (IL-6) that is involved with the immune system and is known to be a key factor for problems with excessive inflammation. Tocilizumab is effective in treating "cytokine storm" from a type of cancer immunotherapy and may be effective in reducing the inflammatory response and "cytokine storm" seen in severe COVID-19 disease. Treating the inflammation may help to reduce symptoms, improve the ability to breathe without a breathing machine (ventilator), and prevent patients from having more complications.
NumaHealth International
During this pandemic period, the goal of the health care system is to optimize the use of intensive care services for patients infected with SARS-CoV-2, given the frequency of complications that can lead to high mortality. When patients with suspected or confirmed COVID-19 are admitted to hospital, whether or not they are symptomatic, there is currently no method to predict who will progress to complications requiring the use of intensive measures in 24-48 hours.
Fondation Santé Roquette
The objective of this study is to determine the prevalence of SARS-Cov2 infection among health care workers exposed of Lille University Hospital, to describe its evolution during the epidemic taking into account the influence of occupational and environmental exposure determinants.
Innate Pharma
The primary objective of this trial is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by acute respiratory distress syndrome (ARDS).