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 230 of 530Uppsala University Hospital
This is an open label, dose escalating safety study of the advanced therapyinvestigational medicinal product (ATIMP) KI-MSC-PL-205, where patients diagnosed withSARS-CoV-2-induced severe acute respiratory distress syndrome (ARDS), according to theBerlin Definition, and who are on respirator/ventilator (used synonymously in thisprotocol) support due to respiratory insufficiency with or without concomitantcirculatory problems, will be included and treated with a single dose of KI-MSC-PL-205.
Genexine, Inc.
The objective of our study is to evaluate safety, tolerability, and immunogenicity ofCOVID-19 preventive DNA vaccine in healthy volunteers.
Bayside Health
This is a randomised placebo controlled phase II trial to examine the efficacy ofantivirals to treat COVID-19 infection compared to placebo for virological cure andimproved clinical outcomes. Individuals will be randomised to the candidate antiviralwhich in the first instance is Favipiravir or matched placebo and randomisation will bestratified according to whether the participant requires hospitalisation or not. Thistreatment will be given in addition to the usual standard of care in the participatinghospital.
Sentien Biotechnologies, Inc.
The purpose of this study is to assess the safety and tolerability of the investigationalproduct, SBI-101, in subjects with an infectious etiology of Acute Kidney Injury (AKI).SBI-101 is a biologic/device combination product designed to regulate inflammation andpromote repair of injured tissue using allogeneic human mesenchymal stromal cells.SBI-101 will be integrated into the renal replacement circuit and patients will betreated for up to 24 hours.
Harvard Medical School (HMS and HSDM)
The aim is to describe the epidemiology and determine the independent risk factors formortality and acute organ injury in AKI and to assess the impact of different treatmentstrategies on survival. This will allow the development of prevention strategies anddesign of appropriately powered intervention studies.
Bandim Health Project
Since the 1960s, studies have shown that oral polio vaccine (OPV) may have beneficialnon-specific effects, reducing morbidity and mortality from other infections than polio.Such beneficial non-specific effect have been observed for other live vaccines, includingmeasles, smallpox and BCG vaccine. For BCG, the vaccine for which the mechanism has beenstudied the most, the effects appear to be mediated through the innate immune system. TheCOVID-19 pandemic caused by the novel coronavirus SARS-CoV-2 has now caused over 7.1million cases and >400,000 deaths worldwide. As everywhere else, it is anticipated thatin Africa the older part of the population will be at risk of severe COVID-19. OPV iswidely used in Africa, but for children. Both polio and coronavirus are positive-strandRNA viruses, therefore it is likely that they may induce and be affected by common innateimmune mechanisms.In a randomised trial at the Bandim Health Project in Guinea-Bissau, the investigatorswill assess the effect of providing OPV vs no vaccine to 3400 persons above 50 years ofage. The trial will have the power to test the hypothesis that OPV reduces the combinedrisk of morbidity admission or death (composite outcome) by at least 28% over thesubsequent 6 months.
Imperial College London
DESIGN Longitudinal prospective observational multicentre study.Primary objective:Understand the immune mechanisms driving COVID-19 disease in patients with a history oflung disease
University 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.