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.
Search Tips
To search this directory, simply type a drug name, condition, company name, location, or other term of your choice into the search bar and click SEARCH. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (e.g., “acute respiratory distress syndrome” or “ARDS”). You may opt to further streamline your search by using the Status of the study and Intervention Type options. Simply click one or more of those boxes to refine your search.
Displaying 90 of 754University 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.
Icahn School of Medicine at Mount Sinai
The mortality rate in SARS-CoV-2-related severe ARDS is high despite treatment with antivirals, glucocorticoids, immunoglobulins, and ventilation. Preclinical and clinical evidence indicate that MSCs migrate to the lung and respond to the pro-inflammatory lung environment by releasing anti-inflammatory factors reducing the proliferation of pro-inflammatory cytokines while modulating regulatory T cells and macrophages to promote resolution of inflammation. Therefore, MSCs may have the potential to increase survival in management of COVID-19 induced ARDS. The primary objective of this phase 3 trial is to evaluate the efficacy and safety of the addition of the mesenchymal stromal cell (MSC) remestemcel-L plus standard of care compared to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2. The secondary objective is to assess the impact of MSCs on inflammatory biomarkers.
Amarex Clinical Research
Comparison of the effects of CYT107 vs Placebo administered IM at 10µg/kg twice a week for two weeks on immune reconstitution of lymphopenic COVID-19 patients.
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.
Bristol-Myers Squibb
The coronavirus disease 2019 (COVID-19) global pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused considerable morbidity and mortality in over 170 countries. Increasing age and burden of cardiovascular comorbidities are associated with a worse prognosis among patients with COVID-19. In addition, serologic markers of more severe disease including coagulation abnormalities and thrombocytopenia, are not uncommon among patients hospitalized with severe COVID-19 infection and are more common in patients who died in-hospital. As the COVID-19 pandemic continues to grow, there is a pressing need to identify safe, effective, and widely available therapies that can be scaled and rapidly incorporated into clinical practice. Understanding the putative mechanism of increased mortality risk associated with abnormal coagulation function and cardiac injury is critical to guide studies of promising therapeutic interventions. Published and anecdotal reports indicate that endothelial dysfunction and thrombosis are common in critically ill patients with COVID-19, including reports of diffuse microvascular thrombosis in the lungs, heart, liver, and kidneys. Patients with cardiovascular disease (CVD) and CVD risk factors are known to have endothelial dysfunction and a heightened risk of thrombosis. A recent study of COVID-19 inpatients from Wuhan, China observed that an elevated D-dimer level greater than 1 ug/mL was associated with an 18 times higher risk of in-hospital death, underscoring the importance of increased coagulation activity as a potential modifiable risk marker that may drive end-organ injury. Given the established link between endothelial dysfunction and thrombosis in patients with cardiovascular disease, and the association between coagulopathy and adverse outcomes in patients with sepsis, the association between increased coagulation activity, end-organ injury, and mortality risk may represent a modifiable risk factor among COVID-19 patients with critical illness. Therefore, we propose to conduct a randomized, open-label trial of therapeutic anticoagulation in COVID-19 patients with an elevated D-dimer to evaluate the efficacy and safety.
Cambia Health Solutions
This retrospective study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on the Medication Risk Score (MRS) in a health insurance population. Our clinical tool would enable us to identify potential multi-drug interactions and potentially reduce the risk of adverse drug events (ADE) developing in these patients infected with COVID-19.
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.
Incyte Corporation
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of participants with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS) who require mechanical ventilation.
Centre Hospitalier Universitaire, Amiens
Since December 2019, a new disease named COVID-19 linked to a new coronavirus, SARS-CoV2 has emerged in China in the city of Wuhan, Hubei province, spreading very quickly to all 5 continents, and responsible for a pandemic. France is the third most affected country in Europe after Italy and Spain. Groups of patients at a higher risk of developing a severe form of COVID-19 have been defined: this include patients with immunosuppressive disease as cancer or patients with advanced cirrhosis of the liver. Coronavirus liver injury had been described with SARS-CoV 1 and MERS-CoV. There is no data on liver damage associated with COVID-19 infection for compensated or decompensated cirrhotic patients. The objectives of this project are to estimate the incidence of COVID-19 in hepatocellular carcinoma population, both hospital and ambulatory, and to study the impact on the frequency of severe forms, the prognosis, but also liver function, and the management of hepatocellular carcinoma, in this context of pandemic
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.