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 60 of 134Biomed Industries, Inc.
This Phase 2/3 trial evaluates four treatment strategies for non-critically illhospitalized participants (not requiring ICU admission and/or mechanical ventilation)with SARS CoV-2 infection, in which participants will receive NA-831 or Atazanavir withor without Dexamethasone.
Uppsala 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.
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.
AB Science
Study objective is to evaluate the efficacy of the combination of masitinib andisoquercetin in adult hospitalized patients with moderate and severe COVID-19.
Medicago
This Phase 2/3 study is a multi-portion design to confirm that the chosen formulation anddosing regimen of CoVLP has an acceptable immunogenicity and safety profile.The Phase 3 portion is an event-driven, randomized, observer blinded, placebo-controlleddesign that will evaluate the efficacy and safety of the CoVLP formulation compared toplacebo.Subjects will be followed for safety and immunogenicity for a period of 12 months afterthe last vaccination.
GeoVax, Inc.
This phase I trial evaluates the side effects and best dose of GEO-CM04S1 (previouslydesignated as COH04S1), a synthetic modified vaccinia Ankara (MVA)-based SARS-CoV-2vaccine, for the prevention of COVID-19 infection. COVID-19 infection is caused by theSARS-CoV-2 virus. SARS-CoV-2 has demonstrated the capability to spread rapidly, leadingto significant impacts on healthcare systems and causing societal disruption. GEO-CM04S1was created by placing small pieces of SARS-CoV-2 DNA (the chemical form of genes) intosynthetic MVA, which may be able to induce immunity (the ability to recognize and fightagainst an infection) to SARS-CoV-2. The purpose of the Phase 1 study is to determine thesafety and the optimal dose of the GEO-CM04S1 vaccine.The Phase 2 study is designed as a multi-center, double-blind, randomized, parallel,study to evaluate the safety profile of 2 dose levels of GEO-CM04S1 as a single boostershot to assess the immune response measured by the fold-increase in antibody againstSARS-CoV-2 Spike protein at day 28 post-injection among healthy adult volunteers.
Case Western Reserve University
The primary objective of this study is to provide expanded access of S-nitrosylationtherapy for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2)infection.
ClinAmygate
Timing of of corticosteroids administration is very important in COVID19 cases for therecovery and decrease the mortality.