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 260 of 335ViralClear Pharmaceuticals, Inc.
The purpose of this study is to assess the safety and efficacy of merimepodib (MMPD) oral solution when administered in combination with remdesivir in adult patients with advanced COVID-19.
Restorbio Inc.
The purpose of this study is to determine if prophylaxis with RTB101 decreases the severity of laboratory-confirmed COVID-19 among adults ≥ 65 years who reside in a nursing homes in which one or more residents or staff have laboratory-confirmed COVID-19
Boehringer Ingelheim
This is a study in adults with severe breathing problems because of COVID-19. People who are in hospital on breathing support can participate in the study. The purpose of the study is to find out whether a medicine called alteplase helps people get better faster. The study has 2 parts. In the first part, participants are put into 3 groups by chance. Participants in 2 of the groups get 2 different doses of alteplase, in addition to standard treatment. Participants in the third group get standard treatment. In the second part of the study, participants are put into 2 groups by chance. One group gets alteplase and standard treatment. The other group gets only standard treatment. Alteplase is given as an infusion into a vein. In both study parts, treatments are given for 5 days. Doctors monitor patients and check whether their breathing problems improve. They compare results between the groups after 1 month. Participants are in the study for 3 months.
CSL Behring
CSL760 is a human hyperimmune product of the purified gamma immunoglobulin (IgG) fraction of human plasma containing polyvalent neutralizing antibodies to SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). CSL is evaluating CSL760 as a passive immunotherapy for COVID-19 (Coronavirus Disease 2019).
Northwestern University
This is a single-center, randomized double blind placebo controlled trial to evaluate the efficacy and safety of novel PAI-1 inhibitor (TM5614) for high-risk patients hospitalized with severe COVID-19 at Northwestern Memorial Hospital. The patients will be randomized in a 1:1 ratio to receive standard of care plus TM5614 or standard of care plus placebo.
Profact, Inc.
This is a platform study to investigate the effectiveness of a variety of non-prescription approaches for the treatment of non-hospitalized adults recently tested positive for COVID-19.
FSD Pharma, Inc.
This study will measure the effect of FSD201 (ultramicronized PEA) + SoC vs placebo + SoC on Day 28, on disease progression in the confirmed coronavirus disease 2019 (COVID-19) patient population.
Legacy Health System
Of the many treatments proposed for COVID-19, few directly address the severe hypoxia among COVID-19 patients. Interim results from our single-center, non-randomized clinical trial (NCT04332081) suggest that hyperbaric oxygen therapy may reduce inpatient mortality or the need for mechanical ventilation among COVID-19 patients by more than half. Hyperbaric oxygen therapy is delivered by increasing the atmospheric pressure surrounding a patient, which results in increased oxygen delivery to a patient's blood at a rate higher than any other available modality. It is already FDA-approved for several indications, including conditions with impaired gas exchange and severe infectious processes. Furthermore, several studies have found that hyperbaric oxygen therapy inhibits the production of proinflammatory cytokines, which may play a role in the pathophysiology of COVID-19. The goal of this proposal is to perform a multi-center, randomized controlled trial to evaluate the short-term and long-term efficacy of hyperbaric oxygen therapy for COVID-19 patients. This proposal will rigorously test whether hyperbaric oxygen therapy can reduce the substantial mortality and morbidity of this challenging disease.
Regeneron Pharmaceuticals
Compassionate Use requests will be considered for individuals who test positive for SARS-CoV-2 and where there is reasonable basis to believe that the patient is infected with a susceptible variant.
Cardiol Therapeutics Inc.
Non-critical patients, hospitalized within the previous 24 hours who tested positive for COVID-19 and have a prior history of cardiovascular disease (CVD) and/or significant risk factors for CVD will be treated for 28 days.