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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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 70 of 246Patient-Centered Outcomes Research Institute
The goal of the study is to examine whether a shared decision making intervention improves decision making about colon cancer screening for patients who had their colonoscopy delayed or postponed due to the COVID pandemic. Eligible patients (n=800) will be randomly assigned to either the intervention or control arm. A subset will be surveyed about 6-8 weeks post intervention to measure shared decision making, their intention to follow through with screening, and their decisional conflict. Study staff will conduct medical chart review to track receipt of colon cancer screening within 6 months. The statistician will test whether patients in the intervention arm report more shared decision making, less decisional conflict, higher intention to follow through on screening and have higher screening rates compared to those in the control arm.
Swedish Medical Center
Administration of Zinc and resveratrol or double placebo for a period of 5 days and will be monitored for a 14 day period in covid-19 positive patients in an outpatient setting
Royal College of Surgeons in Ireland - Medical University of Bahrain
This is an open-label, interventional exploratory study to evaluate the safety and efficacy of 5-ALA-Phosphate + SFC in subjects with acute moderate or severe respiratory illness secondary to infection with SARS-CoV-2 virus (COVID-19) involving 40 subjects. The primary objective is to evaluate the safety of 4-week oral administration of 5-ALAPhosphate + SFC. This study is expected to last for 4 weeks and will include follow-up until day 28 in the hospital or in an outpatient setting if the subjects are discharged earlier.
Charles Drew University of Medicine and Science
African American adults, specifically those managing chronic disease and social isolation, are one of the most vulnerable groups susceptible to COVID-19. This intervention involves a multi-disciplinary and culturally sensitive approach to address two major COVID-19 related challenges in this population. First, this program collaborates with predominantly African American churches to implement Federal and State guidelines aimed at preventing outbreaks of COVID-19 at faith-based gatherings. Second, this program trains church-based health advisors to help African American older parishioners manage their chronic health conditions and reduce psychological distress during the pandemic.
Charles Drew University of Medicine and Science
This proposal seeks to enhance acceptability and uptake of COVID-19 testing and vaccination to engage African American and Latinx public housing residents in South Los Angeles. Given the multiple disparities experienced by public housing residents, the investigators will utilize a theoretically-based, multidisciplinary and culturally tailored intervention to reduce barriers and implement innovate strategies to engage this population in the uptake of COVID-19 testing and vaccination.
Albert Einstein College of Medicine
Our aim is to conduct a pilot single-blind randomized controlled trial to examine the preliminary efficacy of a 14 day app-based pulmonary and mobility focused rehabilitation program (intervention arm) versus a self-guided exercise program (active control arm) on pulmonary and functional outcomes in 100 patients tested for COVID-19 infection and isolated at home.
SILVATEAM
There is an urgent need to evaluate interventions that could be effective against the infection with SARS-CoV 2. Tannins based wood extracts are an inexpensive and safe product with protective effect in both bacterial and viral infections likely due to its anti- inflammatory, anti-oxidative effects and their modulation of the intestinal microbiota. This randomized controlled trial seeks to evaluate the efficacy of the tannins based dietary supplement ARBOX in positive COVID-19 patients.
Direction Centrale du Service de Santé des Armées
Study of SARS-CoV2 Virus (COVID-19) Seroprevalence in the Population of Creil Air Force Base (BA110)
In mid-February 2020, within the Oise (France) cluster, a case of COVID-19 disease caused by a SARS-CoV2 infection was described among the personnel of the Creail Air Force Base (BA110). This resulted in the beginning of an epidemic controlled by epidemiological measures. One month later, containment measures were taken at the national level, measures that also applied to BA110 personnel. These personnel, exposed to both the initial phase of the epidemic and national protection measures, represent an extremely interesting population for understanding the epidemiological dynamics of the virus, particularly at a time when France is lifting the containment measures. It becomes extremely important to understand the levers of viral spread in order to adjust the health measures to be maintained as best as possible. The main objective of this study is to determine the extent of virus diffusion in this highly circulating population, as evidenced by several identified cases of COVID-19.
Rennes University Hospital
Respiratory involvement of SARS-CoV2 leads to acute respiratory distress syndrome (ARDS) and significant immunosuppression (lymphopenia) exposing patients to long ventilation duration and late mortality linked to the acquisition of nosocomial infections. Lymphopenia characteristic of severe forms of ARDS secondary to SARS-CoV2 infection may be linked to expansion of MDSCs and arginine depletion of lymphocytes. Severe forms of COVID-19 pneumonitis are marked by persistent ARDS with acquisition of nosocomial infections as well as by prolonged lymphocytic dysfunction associated with the emergence of MDSC. It has been found in intensive care patients hypoargininaemia, associated with the persistence of organ dysfunction (evaluated by the SOFA score), the occurrence of nosocomial infections and mortality. Also, it has been demonstrated that in these patients, the enteral administration of ARG was not deleterious and increased the synthesis of ornithine, suggesting a preferential use of ARG by the arginase route, without significant increase in argininaemia nor effect on immune functions. L-citrulline (CIT), an endogenous precursor of ARG, is an interesting alternative to increase the availability of ARG. Recent data demonstrate that the administration of CIT in intensive care is not deleterious and that it very significantly reduces mortality in an animal model of sepsis, corrects hypoargininemia, with convincing data on immunological parameters such as lymphopenia, which is associated with mortality, organ dysfunction and the occurrence of nosocomial infections. The availability of ARG directly impacts the mitochondrial metabolism of T lymphocytes and their function. The hypothesis is therefore that CIT supplementation is more effective than the administration of ARG to correct hypoargininaemia, decrease lymphocyte dysfunction, correct immunosuppression and organ dysfunction in septic patients admitted to intensive care. The main objective is to show that, in patients hospitalized in intensive care for ARDS secondary to COVID-19 pneumonia, the group of patients receiving L-citrulline for 7 days, compared to the group receiving placebo, has a score of organ failure decreased on D7 (evaluated by the SOFA score) or by the last known SOFA score if the patient has died or been resuscitated.
Hospital del Río Hortega
Increased Risk of SARS-CoronaVirus-2 (SARS-CoV-2) Infection Associated With Endoscopy (DECORE Study)
The aim of our study to compare the proportion of patients who develop SARS-CoV-2 disease in 3 groups: patients undergoing a abdominal ultrasound examination in a Specialty Center, patients undergoing endoscopic procedure in a third level hospital with CoronaVirus Disease (COVID-19) hospitalization plants and patients who make a telephonic visit (do not go to the hospital) in the digestive system service.