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 150 of 265Imagine Institute
This is a European observational cohort study (data research) involving multiple centresto look at the potential impact of COVID infection on patients with rare skin diseasesexamining factors such as comorbidity, protection factors, and clinical and/ortherapeutic factors. The data collected may provide additional information on thesituation of patients and, on a wider basis, provide useful data applicable to thegeneral population.
Swiss School of Public Health (SSPH+)
There is a lack of knowledge about how many children are infected with SARS-CoV-2, howoften they are asymptomatic, and how long the immunity persists.The main purpose of this study is to measure antibodies to SARS-CoV-2, symptoms, and riskfactors in a representative cohort of children and adolescents in the canton of Zurich,Switzerland, shortly after re-opening of the school system and thereafter. The study alsoinvestigates antibodies to SARS-CoV-2 in parents of the children and school personnel.
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 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.