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 10 of 110CytoDyn, Inc.
The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects with severe or critical COVID-19 disease.
Centro Nacional de Investigaciones Oncologicas CARLOS III
In absence of vaccine and medications specifically designed to treat SARS-CoV-2 disease, identifying treatment options is critical at this time to control the disease outbreak. For this, we have designed a phase II trial of efficacy and safety with 3 branches of different combinations of treatment to identify which is the best early treatment option for patients with pneumonia due to SARS-CoV-2 (Covid-19) Identifying treatment options as early as possible is critical to the SARS-CoV-2 outbreak response. Currently, there is no approved vaccine for the disease and the treatments being used are not specifically designed for the SARS-CoV-2 virus, but are different groups of drugs used for other pathologies with mechanisms of action that justify their use because they inhibit entry of the virus into virus cells or proteases. The study aims to compare Imatinib 400mg, Baricitinib 4mg or supportive treatment, administered for 7 days in the setting of SARS-CoV-2 pneumonia treatment. Patients who meet inclusion criteria and do not have any exclusion criteria will be randomized to receive open treatment 1:1:1
Hellenic Institute for the Study of Sepsis
In the SAVE study patients with lower respiratory tract infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at high risk for progression to serious respiratory failure will be detected using the suPAR biomarker. They will begin early treatment with anakinra in the effort to prevent progression in serious respiratory failure.
University of Alabama at Birmingham
This proposal addresses the problem of preventing the very high mortality and morbidity associated with the development of Cytokine Storm Syndrome (CSS) associated respiratory failure in Covid-19 infection.
Ola Blennow, MD, PhD
Randomized open label clinical trial carried out at study centers in Sweden, including Karolinska University Hospital, S:t Göran Hospital, Danderyd Hospital and Västmanlands Hospital. Patients with COVID-19 who are hospitalized with oxygen therapy are eligible for inclusion. Subjects are randomized to 14 days of inhalation with ciclesonide 360 µg twice daily or to standard of care. Primary outcome is duration of received supplemental oxygen therapy. Key secondary outcome is a composite outcome of death and received invasive mechanical ventilation within 30 days.
Kanuni Sultan Suleyman Training and Research Hospital
Evaluation of the effect of high-dose vitamin C use in covid 19 positive pregnants
Tongji Hospital
A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (COVID-19) emerged at December 2019 in Wuhan, China, and soon caused a large global outbreak. The delayed treatment for many chronic diseases, due to the concern of SARS-CoV-2 infection, is an increasing serious problem. Here the investigators investigate the safety of chemotherapy for patients with gynecological malignancy in Wuhan, the center of high-risk regions of COVID-19.
Topelia Therapeutics
In this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months.
Medical University of South Carolina
The purpose of this study is to evaluate how useful vitamin D supplementation is in reducing the severity of COVID-19 symptoms and the body's inflammatory and infection-fighting response to COVID-19. Individuals ≥50 years of age and older who are tested for COVID-19 and negative will be randomized (like flipping a coin) to either daily high dose vitamin D supplementation (6000 IU vitamin D3/day) vs. standard of care. Those individuals ≥50 years of age or older who test positive for COVID-19 at baseline will be randomized to bolus vitamin D (20,000 IU/day for 3 days) followed by high dose (6000 IU vitamin D/day) vs. standard of care for 12 months. All participants will receive a multivitamin containing vitamin D.
Brigham and Women's Hospital
Ultomiris (Ravulizumab), is a monoclonal antibody that specifically targets terminal complement products and is proposed for the treatment of COVID-19 induced microvasculature injury and endothelial damage leading to thrombotic microangiopathy (TMA) causing acute kidney injury (AKI). Ravulizumab is to be used for participants with a confirmed diagnosis of COVID-19 who clinically or diagnostically present with deteriorating renal function. Ravulizumab causes immediate and sustained inhibition of the terminal complement cascade. The use of ravulizumab could ameliorate COVID-19 induced kidney injury due to TMA, shorten hospital stay, and improve the overall survival.