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.
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A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized with COVID-19
National Institutes of Health (NIH)
The purpose of this research study is to determine if high-frequency, rapid turn-around SARS-CoV-2 surveillance testing with this assay is feasible and able to be optimized to enable isolation and follow-up diagnostic testing. This test will be performed at various locations in the Madison, Wisconsin area using a mobile laboratory or standard lab space for processing. Saliva samples can be collected and processed at these locations or participants can self-collect at home and drop their samples off at designated locations for same day processing. Up to 10000 participants will be recruited for this study.
Central Hospital, Nancy, France
Mesenchymal stem cells (MSCs) are of potential help in acute respiratory distress syndrome (ARDS), due to their anti-inflammatory properties. The investigators will analyze the effect of 3 iterative infusions of ex vivo expanded Wharton's Jelly MSCs (total dose 2.10^6/kg) in patients with ARDS due to COVID19, who require mechanical ventilation.
Capricor Inc.
This is a randomized, double-blind, placebo-controlled, Pilot, Phase 2 Exploratory study that will enroll subjects with a clinical diagnosis of COVID-19 confirmed by laboratory testing and who are in severe or critical condition as indicated by life-support measures.
Azienda USL Toscana Nord Ovest
Aim of the study is to verify the efficacy and safety of convalescent hyperimmune plasma infusion in hospitalized covid-19 patients non in ITU with pneumonia and respiratory symptoms within seven days from the beginning of symptoms. Efficacy is evaluated by the number of patients who will improve their clinical condition and will not be admitted to ITU. .Safety is considered in relation to adverse reactions to plasma infusion.
FUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA
This is a prospective, randomized (1:1), double blind study of Convalescent anti-SARS-CoV-2 MBT Plasma (also known as convalescent plasma) plus standard medical treatment (SMT) versus placebo plus SMT in mild or moderate COVID-19 patients who are non-hospitalised. Subjects with confirmed infection by SARS-CoV-2 will receive SMT plus a total of 200-300 mL of convalescent plasma that has been pathogen-inactivated using MBT or placebo. Approximately 474 individuals will be randomized (1:1) with an interim analysis after the first 60 subjects (30 in each arm). The sample size will be re-assessed upon interim analysis. Approximately 135 individuals from selected study sites will be included in the substudy to assess the immune response and the methods of sampling. This is a prospective, randomized (1:1), double blind study of Convalescent anti-SARS-CoV-2 MBT Plasma (also known as convalescent plasma) plus standard medical treatment (SMT) versus placebo plus SMT in mild or moderate COVID-19 patients who are non-hospitalised. Subjects with confirmed infection by SARS-CoV-2 will receive SMT plus a total of 200-300 mL of convalescent plasma that has been pathogen-inactivated using MBT or placebo. Approximately 474 individuals will be randomized (1:1) with an interim analysis after the first 60 subjects (30 in each arm). The sample size will be re-assessed upon interim analysis. Approximately 135 individuals from selected study sites will be included in the substudy to assess the immune response and the methods of sampling. The investigational product will be administered by IV infusion at baseline. Participants will continue their standard medical treatment (SMT) for SARS-CoV-2 infection as prescribed by their regular physician. If applicable, SMT may be modified during the study, depending on personal requirements, the severity and progression of the disease, and need for hospitalization. Subjects' participation (from inclusion/baseline visit to the end-of-study visit) will be up to 60 days.
University of Utah
The purpose of this study is to test the effect of purified (acellular) amniotic fluid as a treatment for SARS CoV-2 (COVID19)-associated respiratory failure. Past use of human amniotic products (i.e., membrane and fluid) is FDA-approved for tissue injury and has been used to reduce inflammation and fibrosis in patients with a variety of medical conditions. The investigators hypothesize that using nebulized and/or intravenous purified (acellular) amniotic fluid will reduce both inflammation in patients hospitalized for in SARS CoV-2 (COVID19)-associated respiratory failure, potentially leading to a decrease in respiratory support.
Laval University
There is a high risk of transmission of COVID-19 to healthcare workers. In a recent cohort, 29% of the patients hospitalized were healthcare workers. Among the WHO's primary strategic objectives for the response to COVID-19, the first was to limit human-to-human transmission, including reducing secondary infections among close contacts and health care workers. Automated oxygen titration, weaning and monitoring (FreeO2 device) may be a solution to reduce the number of interventions of healthcare workers related to oxygen therapy, to reduce complications related to oxygen and to improve monitoring.
Azidus Brasil
This is phase II study to assess the efficacy of NestaCell® (mesenchymal stem cell) to treat severe COVID-19 pneumonia.
VivaChek Laboratories, Inc.
This study aim to evaluate the immune response of negative patients during a COVID-19 outbreak. Patients are serially tested with a VivaDiag ™ COVID-19 lgM / IgG Rapid Test to evaluate the immune response in negative patients and the reliability of the test in those patients who develop clinical signs of COVID-19 during the trial.