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 80 of 744Roche Pharma AG
A phase II clinical trial will be carried out with the objective of studying the impact of the administration of Tocilizumab on the evolution of the acute respiratory distress syndrome (ARDS) in patients with severe or critical SARS-CoV-2 infection. Due to the high mortality of severe forms of SARS-CoV-2 and for ethical reasons, a control arm will not be included. Patients will be recruited by signing an informed consent and the baseline variables of interest will be recorded. Tocilizumab will be administered in one or two doses, depending on the case, and will be followed up for 30 days. The response to treatment, survival and evolution will be studied. Factors associated with improvement of ARDS and survival will be identified through multivariate analyzes. The results will be compared with those reported internationally.
University of British Columbia
Emergent experimental and anecdotal evidence has indicated that critically ill COVID-19 patients demonstrate two patient sub-types (called phenotypes). In one group the disease progresses slowly and patients have a low potential of developing mild respiratory failure, but in the other group, an exaggerated immune response (hyper-inflammation/cytokine storm) may be linked to the onset of precipitous respiratory failure, termed acute respiratory distress syndrome. This syndrome is responsible for a large portion of COVID-19 associated mortality. Thus, determining links between hyper-inflammation and acute respiratory distress syndrome in COVID-19 patients is of immediate importance. Blood samples will undergo a number of analyses to help us to understand as much as possible about COVID-19. We will also study any differences in physiologic and cytokine levels before and after patients are treated with immunomodulatory therapies as part of clinical care in COVID-19 patients.
Sanford Health
This is a prospective, double-blind, randomized, placebo-controlled study in two distinct cohorts to evaluate the efficacy and safety of hydroxychloroquine in the prevention of COVID-19 infection.
Hasselt University
The primary objective of the study is to evaluate cardiac and pulmonary hemodynamic changes over time as predictor of disease progression and outcome in COVID-19 patients admitted to ICU. The primary endpoint is the occurrence of a major event predefined as either: death (all-cause mortality) or discharge from ICU (limit of 4 months). This is a uni-center prospective observational cohort study with an inclusion period of 2 months. The end of the study is foreseen in 6 months.
Rabin Medical Center
The coronavirus disease 2019 (COVID-19) is an emerging pandemic in 2020 caused by a novel coronavirus named SARS-CoV2. Diabetes confers a significant additional risk for COVID-19 patients. Dipeptidyl peptidase 4 (DPP-4) is a transmembrane glycoprotein expressed ubiquitously in many tissues. In addition to its effect on glucose levels, DPP-4 has various effects on the immune system and several diseases, including lung diseases. This trial aims to assess the safety and efficacy of linagliptin, a DPP-4 inhibitor, in the treatment of COVID-19. The trial will be randomized without blinding, with one are treated by insulin only for glucose balance and the other by insulin and linagliptin. The trial will assess the effects of linagliptin on different measures of COVID-19 recovery.
University 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.