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 30 of 119Humanetics Corporation
This is a randomized, double-blinded, placebo-controlled, two-arm study to evaluate thesafety and efficacy of BIO 300 Oral Suspension (BIO 300) as a therapy to improve lungfunction in patients that were hospitalized for severe COVID-19-related illness andcontinue to experience post-acute respiratory complications associated with Long-COVIDafter discharge. Patients will be randomized 1:1 to receive BIO 300 or placebo.
University Health Network, Toronto
Recent studies have shown that some individuals may be asymptomatic but continue to shedthe COVID-19 virus. These individuals may represent a population that can unknowinglytransmit the virus. Healthcare workers (HCW) may acquire COVID-19 from the community orfrom possibly infected patients. It is important to gather data with respect to this tofurther understand the prevalence of asymptomatic carriage in individuals who work inresearch facilities, offices and clinical areas of hospitals and researchfacilities/institutes since this has important implications for infection control, aswell as staff and patient safety. The purpose of this study is to test whether aproportion of these individuals may be asymptomatic shedders of the COVID-19 virus.
University of Kansas Medical Center
Establish a COVID-19 biorepository to aid in developing our knowledge of the disease.
Imperial College London
The proposed study is designed to investigate if and how pregnant women infected withCoronavirus Disease-19 (COVID-19) infection go on to develop long-term immunity. InDecember 2019, a group of people in Wuhan, China presented with symptoms of a pneumoniaof an unknown cause that led to the discovery of a new coronavirus called COVID-19.COVID-19 has caused a global pandemic with 7,140,000 confirmed cases and 418,000 deathsas of 13th June 2020. In the United Kingdom (UK), there have been 294,000 cases and41,662 deaths as of 13th June 2020. In humans, this infection primarily involves theupper part of the lungs, but it can also affect other organs. It causes mild symptoms inthe majority of people affected but some people can have severe infections, with someeven requiring critical care in hospital. During Severe acute respiratory syndrome(SARS), a previous coronavirus epidemic, pregnant women were disproportionately affectedwith severe illness. Understanding how the immune system responds long-term to thisinfection may hold the key to developing better vaccines and efficient treatment plans.Specialised immunity develops when individuals are infected by this and other viruses.The investigators of this study propose that, in pregnancy, this specialised immunity maynot behave effectively. This may affect their ability to develop long lasting immunityand make them more vulnerable to re-infection. In this study, the investigators aim torecruit patients across 6 groups including COVID-19 newly infected pregnant women, andpeople with differing illness severity, mild to moderate, severe/critical, no infection(controls), as well as pregnant women with influenza and those receiving influenzavaccine. The study team will compare COVID-19 in pregnancy with non-pregnant infected andwith influenza infected and vaccinated pregnant women. The study team will consentpatients in all of these groups to provide a series of blood samples at different timepoints in a 12-month period.
Centre Hospitalier Universitaire, Amiens
This study aims to determine how long COVID-19 neutralizing antibodies can be detected inan elderly institutionalized population presenting fragility factors.This study also aims to stratify seroconversion by immunological profiles of the elderlypatients residing in the EHPAD. This stratification requires the measurement ofimmunological marker levels already described in immunosenescence and also involved inthe development of certain chronic infectious diseases more common in the elderlypopulation. This analysis will enable the investigators to describe an immunological,clinical and biological profile representing a patient who has developed an immunityagainst COVID 19. It will also help the investigators to understand the differentmechanisms leading to a reduced immune response after a potential administration of avaccine. Finally, it will help describe the immune profiles of elderly residents whopresented with non-severe forms of COVID-19.
Oslo University Hospital
NORPLASMA COVID-19 includes both the production of convalescent plasma from approvedblood donors who have recovered from covid-19 (coronavirus disease 2019), and clinicalstudies to evaluate efficacy and safety of the treatment, as recommended by Europeanhealth authorities. Patients who receive convalescent plasma in a clinical setting willbe invited to participate in the monitoring study NORPLASMA MONITOR, where clinical dataabout safety and effect on clinical parameters including virus load and recovery timewill be collected and compared to european patients in a common database for the Europeancountries. The treated patients can be compared to a historical control group.
Sanofi
Primary Objective:To determine the efficacy of SAR442168 compared to placebo in delaying disabilityprogression in primary progressive multiple sclerosis (PPMS)Secondary Objectives:To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magneticresonance imaging (MRI) lesions, cognitive performance, physical function, and quality oflife To evaluate safety and tolerability of SAR442168 To evaluate populationpharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety Toevaluate pharmacodynamics of SAR442168
Pfizer
A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 asMonotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors
Instituto de Medicina Regenerativa
This is a pilot phase, open label, non-randomized study for the treatment of ARDS inpatients infected with COVID-19. Subjects will be enrolled and treated with one dose ofmesenchymal stem cells and follow-up will occur 90 days post-treatment.
National Cancer Institute (NCI)
This study uses questionnaires to gain an understanding of how experiences during theCOVID-19 pandemic, regardless of COVID-19 status, may have impacted health-relatedquality of life (HRQOL) and other areas such as COVID-19-specific psychological distress,disruptions to health care, finances and social interactions in cancer patients. Thecoronavirus disease 2019 (COVID-19) is an infectious disease that is caused by the severeacute respiratory syndrome coronavirus 2 (SARS-CoV-2). The information learned from thisstudy will guide the development of psychosocial programs to improve patient care andoutcomes in cancer patients and survivors in the context of facing a global pandemic.