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 200 of 383University of Giessen
By the end of 2019 a new coronavirus, named SARS-CoV-2, was discovered in patients withpneumonia in Wuhan, China. In the following weeks and months the virus spread globally,having a tremendous impact on global health and economy. To date, no vaccine or therapyis available. Severe courses of the infection not only affect the lungs, but also otherorgans like the heart, kidney, or liver. The lack of preexisting immunity might at leastpartially explain the affection of extra pulmonary organs not yet seen in infections dueto other respiratory viruses. In this observational investigation the study group willfollow up on patients that have been hospitalized due to a SARS-CoV-2 infection, andmonitor sequelae in various organs, with an emphasis on the pulmo-cardiovascular system.Our that in some patients, organ damage will persist and require long-term medical care.
King's College London
The aims of the BIBS StudyThe Brain Imaging in Babies study (BIBS) aims to improve understanding of how a baby'sbrain develops from before birth, up until 3-4 years of age. Working with children from avariety of backgrounds and communities, the investigators use a combination ofstate-of-the-art diagnostic tools such as MRI scans alongside traditional behaviouralassessments to capture the earliest information on infant brain development.The focus of the BIBS studyMRI scanning is a safe way of producing detailed images using strong magnetic fields andradio waves. It does not use X-ray. Along with learning more about brain development ingeneral, the investigators also try to identify features that may in future help predictwhether a child will or will not develop traits of conditions such as Autism SpectrumDisorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD). Long-term, this mayhelp target useful interventions early on, helping children who are most in need.Since COVID-19 arrived in the United Kingdom (U.K.) in 2020, the investigators have beengiven ethical approval to include testing for this infection in the mothers and childrenparticipating in the study. This may provide an opportunity to better understand howmother and baby respond to infections. The investigators particularly welcome mothers whohave had a positive COVID-19 test during their pregnancy to join the study.
University of Sao Paulo
The aim of this work is to conduct a randomized, double-blind, placebo-controlledclinical trial to assess the efficacy and safety of cannabidiol (CBD - 300 mg a day) inpatients infected with SARS-CoV-2.The specific objectives are to assess whether, in patients with mild and moderate formsof SARS-CoV-2, daily use of CBD 300 mg for fourteen days is capable of:i) decrease viral load; ii) modify inflammatory parameters, such as cytokines, measuredfrom serum; iii) reduce clinical and emotional symptoms through daily clinicalevaluation; iv) improve sleep; v) reduce hospitalization and worsen the severity of thedisease; v) Monitor the possible adverse effects of CBD use in these patients.
SAb Biotherapeutics, Inc.
: Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developedSAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic [Tc]bovine-derived), as a potential therapeutic to treat COVID-19. This study will evaluatethe safety, immunogenicity, and pharmacokinetics of SAB-185 in ambulatory participantswith COVID-19.
Bernhoven Hospital
Rationale: Infection with severe acute respiratory syndrome coronavirus (SARS-CoV) 2could result in endothelial dysfunction with increased risk of arterial thrombotic eventsby downregulating the expression of angiotensin converting enzyme 2 (ACE2). Endothelialfunction can be easily and non-invasively determined by carotid artery reactivity (CAR)testing.Objective: To investigate the predictive value of endothelial dysfunction, measured bycarotid artery reactivity testing, for 1-year cardiovascular events in patients with pastCOVID-19 infection.Study design: A prospective observational longitudinal cohort study.Study population: Patients recovered from confirmed infection with SARS-CoV2.Main study parameters/endpoints: macrovascular endothelial function measured by carotidartery reactivity testing.
Ludwig-Maximilians - University of Munich
Covid-19, a commonly severe respiratory tract infection caused by the SARS-CoV2Coronavirus, poses an increasing threat to individual health and health care systems. Theindividual disease course ranges from mild to life threatening, the pandemic spread leadsto a shortage of health care resources including intensive care availability. It shouldbe the overarching goal to allocate sparse health care resources to those most at needand to simultaneously avoid unnecessary blocking of resources by clinically unjustifiedhospitalizations.Individuals with preexisting cardiovascular conditions are at the highest risk of healthdeterioration, even at younger age. Objective criteria for hospitalization are notimmediately available in a outpatient settings. Hence, hospitalization and emergencymedical contact is often triggered by subjectively interpreted symptoms. The goal of thisproject is thus to improve the availability of objective measurements in the outpatientsetting by means of an innovative, smartwatch mediated telemedicine approach.To achieve this goal, the investigators will conduct a randomized clinical trialcomparing a smartwatch based telemedicine intervention with standard of care. Theintervention group will receive regular objective measurements of heart rate, ECG, andSpO2 and will get access to a 24/7 medical care hotline for consultation. Theinvestigators hypothesize that the intervention group will benefit by a significantreduction in unnecessary hospitalizations and unplanned emergency medicine contacts.
National Cancer Institute (NCI)
The primary purpose of this study is to gain an understanding of how experiences duringthe COVID-19 pandemic, regardless of COVID-19 status, may have impacted multiple domainsof health-related quality of life and other areas such as COVID-19 specific psychologicaldistress, and disruptions to health care, finances and social interactions. We will alsoevaluate the extent to which resiliency factors such as social support, perceivedbenefits under times of stress, and ability to manage stress may buffer associationsbetween COVID-19 experiences and HRQoL. To meet these objectives, we have developed a10-minute questionnaire that taps into these areas and is based on prior work addressingconcerns of other pandemics or national crises. Participants will have previouslyconsented to protocol PA15-0336 and have provided prior lifestyle data. This will allowus to connect the COVID-19 survey data with prior existing data.
Uppsala University Hospital
The study will follow COVID-19 patients who required intensive care after 3-6 months andone year after discharge from the ICU with functional level as well as organ function toassess recovery after COVID-19. Blood and urine will be collected for biobanking.
Children's Hospital Medical Center, Cincinnati
The purpose of this research study is 1) to conduct a prospective longitudinalsurveillance research trial, enrolling up to 200 CCHMC employees as they come back towork, and then following their clinical and laboratory parameters for up to 12 months;and 2) to support the ongoing development of diagnostic techniques for COVID-19. Theoverall goal is to investigate patterns of SARS-COV-2 infection, including immunologicalrecovery and genetic risk factors, among CCHMC employees to better understand how tosafely reintroduce the CCHMC work force back into their normal routines.
InCor Heart Institute
This is a prospective, randomized, single-center, open-label controlled trial, designedto compare the efficacy of two ventilation strategies (Low Tidal Volume and positiveend-expiratory pressure (PEEP) based on the Acute Respiratory Distress Syndrome (ARDS)Network low PEEP-fraction of inspired oxygen inspired oxygen fraction (FIO2) Table versusLow Driving Pressure and PEEP guided by Electrical Impedance Tomography (EIT) in reducingdaily lung injury score in patients with acute respiratory distress syndrome caused byCOVID-19. The two strategies incorporate different prioritizations of clinical variables.The PEEP-FIO2 table strategy aims to reduce lung overdistension, even if it requirestolerating worse gas exchange. EIT-guided strategy prioritizes mechanical stressprotection, avoiding alveolar overdistension and collapse.