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 120 of 245University of Chicago
Tocilizumab is an effective treatment for severe coronavirus disease 2019 (Covid-19)pneumonia and related inflammation. Given limited global supplies, clarification of theoptimal tocilizumab dose is critical. We conducted an open-label, randomized, controlledtrial evaluating two different dose levels of tocilizumab in Covid-19 (40mg and 120mg).Randomization was stratified on remdesivir and corticosteroid at enrollment. The primaryoutcome was the time to recovery. The key secondary outcome was 28-day mortality.
QuantumLeap Healthcare Collaborative
The goal of this project is to rapidly screen promising agents, in the setting of anadaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase2 platform design, agents will be identified with a signal suggesting a big impact onreducing mortality and the need for, as well as duration, of mechanical ventilation.
Johns Hopkins University
This is a a randomized double blind placebo controlled Phase 2 trial with a 12 patientlead-in to evaluate safety, prior to full enrollment to an additional 28 patients (for atotal of 40 patients) to assess efficacy of decitabine in the treatment of critically illpatients with COVID-ARDS. The patients will be randomized in a 1:1 ratio to receivestandard of care plus Decitabine or standard of care plus saline based placebo. Theprimary objective is to determine safety and efficacy of decitabine for COVID-19 ARDSbased on clinical improvement on a 6-point clinical scale.
University of Melbourne
An International Multi-Centre Randomised Adaptive Platform Clinical Trial to Assess theClinical, Virological and Immunological Outcomes in Patients with SARS-CoV-2 Infection(COVID-19).
City of Hope Medical Center
Plasma from patients who have recovered from coronavirus disease 2019 (COVID-19) isreferred to as COVID-19 convalescent plasma (CCP), and may contain antibodies againstSARS-CoV-2, the virus responsible for COVID-19. CCP infusion is being evaluated as atherapeutic or prophylactic approach in COVID-19 patients. The goal of this study is tohelp develop a bank of convalescent plasma in California, especially in medicallyunderserved communities particularly affected by the disease. In parallel, CCPadministered to COVID-19 patients will be collected and analyzed to determine whether theantibody profile correlates with clinical outcome. The purpose of this non-therapeuticstudy is to learn more about the CCP antibody profile and the effect it may have intreating COVID-19 infection.
Mayo Clinic
The purpose of this study is to test whether Fisetin, a senolytic drug, can assist inpreventing an increase in the disease's progression and alleviate complications ofcoronavirus due to an excessive inflammatory reaction.
Methodist Health System
This is a prospective cohort observational registry study that will include data on allpatients who are treated at MHS facilities for COVID-19.
University of Edinburgh
COVID-19 is a community acquired pneumonia caused by infection with a novel coronavirus,SARS CoV2 and is a serious condition with high mortality in hospitalised patients, forwhich there is no currently approved treatment other than supportive care. Urgentinvestigation of potential treatments for this condition is required.This protocol describes an overarching and adaptive trial designed to provide safety,pharmacokinetic (PK)/ pharmacodynamic (PD) information and exploratory biologicalsurrogates of efficacy which may support further development and deployment of candidatetherapies in larger scale trials of COVID-19 positive patients receiving normal standardof care.Given the spectrum of clinical disease, community based infected patients or hospitalisedpatients can be included. Products requiring parenteral administration will only beinvestigated in hospitalised patients. Patients will be divided into cohorts, a)community b) hospitalised patients with new changes on a chest x-ray (CXR) or a computedtomography (CT) scan or requiring supplemental oxygen and c) hospitalised requiringassisted ventilation. Participants may be recruited from all three of these cohorts,depending on the experimental therapy, its route of administration and mechanism ofaction. The relevant cohort(s) for any given therapy will be detailed in thetherapy-specific appendix.Candidate therapies can be added to the protocol and previous candidates removed fromfurther investigation as evidence emerges. The trial will be monitored by an independentData Monitoring Committee (DMC) to ensure patient safety.Each candidate cohort will include a small cohort of patients randomised to candidatetherapy or existing standard of care management dependent on disease stage at entry.Cohort numbers will be defined in the protocol appendices.This is a Phase IIa experimental medicine trial and as such formal sample sizecalculations are not appropriate.
European Institute of Oncology
A huge number of initiatives about COVID-19 are ongoing and a growing number ofpublications regard the correlation between cancer patients in general and SARS-CoV-2infection. Although it has been reported that cancer patients are at a higher risk ofSARS-CoV-2 infection and COVID-19 complications, data collection about cases of NENpatients SARS-CoV-2 positive are scattered and related to single countries orinstitutions. Because of that and due to the rarity and heterogeneity of NEN it will behard to have homogeneous, reliable, representative and reproducible data for drawingadequate clinical recommendations about NEN patients and COVID-19.Therefore we propose a global collection of data through an international database todescribe and monitor NEN patients with SARS-CoV-2 infection. Thisretrospective/prospective collection of data can create a solid basis to check frequenceof events, clinical management, clinical outcome, demographic, geographical, clinical andbiological correlations. This will be helpful for the clinical and scientific communityto get reliable information for a homogeneous clinical management of NEN patients duringCOVID-19 pandemic.The main goal is to get the as wide as possible representativity of the world situation.
University of South Alabama
This Phase 2 Randomized Placebo Controlled Trial will determine if administeringnebulized Dornase Alpha (rhDNase) to COVID-19 patients with respiratory failure is safeand will reduce 28-day mortality.