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 110 of 499Rutgers, The State University of New Jersey
This study will collect data on physical activity, food consumption, stress, sleep, and alcohol consumption habits both before and after the national emergency for COVID-19 was put into place. This will help identify the health behavior changes taking place due to the COVID-19 pandemic in the United States. Data on past and current health behaviors will be self-reported by participants via a single online survey. The retrospective health behavior questions will be the same quantitative questions as the current health behavior questions so a direct comparison can be made. There will be a couple qualitative questions to assess what each participant feels are the greatest barriers or impacts to their current health behaviors. Participants will be recruited via convenient sampling. Data collected in this study will show a decline in at least one healthy behavior after the United States national emergency for COVID-19.
Jewish General Hospital
Coronavirus disease 2019 (COVID-19) is an infectious disease. Physical distancing is one of the most effective ways to reduce the spread of COVID-19, but this key prevention intervention may have adverse consequences on older adults living at home. Screening older adults living at home and at risk for adverse consequences of physical and social distancing is, therefore, a priority in order to prevent their occurrence. ESOGER ("Evaluation Social et GERiatrique") is a clinical tool designed to: 1) screen the risk-levels for adverse consequences related to COVID-19 physical distancing and 2) to continue appropriate preventive interventions in older adults living at home including frail older patients and older community dwellers. Experience cumulated during the past two weeks revealed that ESOGER could be improved, in order to be more effective and efficient for the prevention of adverse consequences related to COVID-19 physical distancing. This improvement is based on two key components: 1) Comments of Montreal ESOGER users and 2) Analysis of data. Because at this time no information is saved and stored, there is a need to save and store ESOGER information and create the ESOGER databank.
Academisch Ziekenhuis Maastricht
Most patients undergoing a cardiovascular procedure need an ICU-bed during the hospitalization and therefore it is possible that for the unforeseen future, because of the Covid-19 crisis, many patients will stay on the waiting list for many months to come. There are some studies showing an increased mortality associated with an increased waiting time for the patients on the waiting list for an elective cardiac surgery. However, there is no data on the evolution of the morbidity, the quality of life and the symptomatology of the patients waiting for an elective operation. Also it is not clear whether the period of waiting for an elective cardiovascular operation would impact the morbidity or the mortality of the planned operation at later stage. Furthermore, there is a plethora of studies on risk factors associated with the perioperative morbidity and mortality in general. Therefore, the rationale of the current study is to evaluate whether Digital Cardiac Counseling (DCC) would improve outcomes of the patients waiting for an elective cardiac operation. At the DCC platform, there will be assessments of cardiovascular symptoms, Covid-19 prevention for cardiovascular patients, smoking cessation, anxiety relief, exercise stimulation, pulmonary rehabilitation and diet adjustments. This will be done by means of questionnaires and E-consults.
BioMérieux
Infection with the SARS-CoV-2 coronavirus (COVID-19) has recently been identified as a pandemic due to the speed and global scale of its transmission. In Auvergne-Rhône-Alpes region (AURA), the epidemic began in February 2020 and the number of infected people is still important. Between 15 and 20% of COVID-19 patients develop an acute respiratory distress syndrome (ARDS) leading to their hospitalization in intensive care. Their clinical progression can be rapidly harmful with the development of severe ARDS associated with an increased risk of death. Preliminary data on the immune response of COVID-19 patients describe the induction of a moderate inflammatory response and the occurrence of major progressive lymphopenia over time associated with potential immunosuppression. Up to 50% of secondary infections are reported in deceased COVID-19 patients. However, no prospective study has exhaustively described the kinetics of the immune response of COVID-19 patients in intensive care. The precise description of the immune response over time in adult patients with a proven infection with the SARS-CoV-2 virus and the study of the relation between this response and the increased risk of organ failure (severe ARDS), death or nosocomial infection will allow us to better understand the pathophysiology of the immune response induced by COVID-19 in order to (i) identify new therapeutic strategies targeting the host response in patients in intensive care (ii) to develop biological markers to stratify patients for future clinical trials evaluating these immunoadjuvant treatments in COVID-19.
National Institute of Allergy and Infectious Diseases (NIAID)
This study aims to address the following objectives: 1. To determine the efficacy of IC14, an anti-CD14 chimeric monoclonal antibody, in patients hospitalized with respiratory disease and hypoxemia due to SARS-CoV-2, in terms of improving the time to resolution of disease. 2. To determine the efficacy of IC14 in reducing the severity of respiratory disease in patients hospitalized with respiratory disease due to SARS-CoV-2. 3. To determine the safety of IC14 in patients hospitalized with respiratory disease due to SARS-CoV-2.
Kaohsiung Kai-Suan Psychiatric Hospital
The Coronavirus disease 2019 (COVID-19) had its outbreak in late 2019 in China and is considered a biological disaster. With medical organizations and staff on the frontline, the investigators should conduct assessments, for the different tiers of medical staff, patients, and community residents, on the short- term psychological and mental disabilities or danger factors that they might have faced. As such, the investigators can design and establish a set of evaluative indicators of the risks of biological disasters, and strategies to manage guide and cope, and internal/ external testing strategies. These work in guaranteeing quality and performance, and as such, establishing "Digital Platform for Integrated Research of Coronavirus disease 2019 (COVID-19)".
Pluristem Ltd.
This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.
Andrew Eisenberger
This is a double-blinded, randomized control trial to assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma as early treatment. Participants will be randomized 2:1 to receive either convalescent plasma qualitatively positive for SARS-CoV-2 antibody ("anti-SARS-CoV-2 plasma") or control (albumin 5%). This study will investigate the potential of convalescent plasma (CP) to reduce severity of and/or help treat SARS-CoV-2 disease in patients with mild disease.
National Cancer Institute (NCI)
This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.
The Marcus Foundation
This is a 50 patient, Phase 1/2a multi-center pilot study to test the safety and to describe the preliminary efficacy of intravenous administration of allogenic human cord tissue mesenchymal stromal cells (hCT-MSC) as an investigational agent, under U.S. INDs 19968 (Duke) and 19937 (U Miami) to patients with acute respiratory distress syndrome (ARDS) due to COVID-19 infection (COVID-ARDS). The first 10 consecutive patients will receive investigational MSCs manufactured by Duke. In the second phase of the study, 40 additional patients will be randomized to receive placebo or investigational MSCs manufactured by Duke or University of Miami. Patients will be eligible for infusion of 3 daily consecutive doses of hCT-MSC or placebo if they have a confirmed diagnosis of COVID-19 and meet clinical and radiographic criteria for ARDS. Results from the first 10 patients will be compared with concurrent outcomes utilizing standard of care treatments in participating hospitals and in published reports in the medical literature. Results from the additional 40 patients will be combined with the first 10 and analyzed. The trial is relying on focused eligibility of the participants (patients with ARDS), single cohort with short trial time (4 weeks), and simple assessment of clinical outcome (survival, improvement of ARDS). This is a sequential design in the sense that after the first 10 patients are evaluated a decision will be made by the PIs and the Data Safety Monitoring Board whether to proceed with the exploratory randomized portion of the study.