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.
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A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized with COVID-19
King Hussein Cancer Center
This is a pilot, randomized, single-center, parallel group, open-label controlled study to evaluate the feasibility, safety, efficacy, and pharmacokinetics of nebulized HCQ01 plus Standard of Care (SOC) versus SOC alone in hospitalized cancer patients with COVID-19. King Hussein Cancer Center (KHCC) is the study sponsor, and the study will be conducted at KHCC COVID-19 wards. Approximately 28 cancer patients, ≥18 years of age with a confirmed SARS-CoV-2 infection, will be enrolled and randomized 1:1 to the treatment and control arms where they will receive ten doses of Hydroxychloroquine solution via nebulizer in addition to SOC or the control arm where treatment will follow KHCC SOC.
Hospital Universitario Infanta Leonor
The main objective is to evaluate the efficacy and safety of three doses of tinzaparin (prophylactic, intermediate and therapeutic) in hospitalized patients with COVID-19 pneumonia.
Zydus Lifesciences Limited
ZYIL1 is a novel oral selective NLRP3 inflammasome inhibitor which prevents NLRP3-induced ASC oligomerization, thus inhibiting NLRP3 inflammasome pathway. ZYIL1 is expected to show benefit in patients demonstrating cytokine, like IL1β flare, including those exhibiting cytokine storm related to COVID-19 and other viral inflammatory diseases.
Sorrento Therapeutics, Inc.
This is a Phase 2, randomized controlled, multicenter study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care (SOC) treatments for COVID-19 infection in hospitalized subjects with ARD/ARDS.
Applied Biology, Inc.
The purpose of this study is to assess the efficacy and safety of Proxalutamide as a treatment for hospitalized COVID-19 male and female patients.
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Myocardial infarction (MI), as one of the many complications of COVID-19, is one of the contributing patients of patients' death. This study attempts on developing an intervention of MI by regenerating damaged cardiomyocytes due to insufficiency of oxygen in cardiac muscles, triggered by an occlusion of coronary artery (MI). Heart patch developed from amnion bilayer seeded with amnion epithelial stem cells and patient's autologous cardiomyocytes is used as a therapy. Patients who undergo bypass (CABG) surgery are given heart patch, and then patients condition are observed by ECG, Echo, blood test, and radiology (technetium-99m)
M.D. Anderson Cancer Center
This is a phase Ib trial with SAR439459, a TGF-beta inhibitor, in combination with cemiplimab, a PD-L1 inhibitor, in patients with solid tumors that have spread to other places in the body (advanced) or cannot be removed by surgery (unresectable). Inhibiting TGF-beta may interfere with the ability of cancer cells to grow and spread and may sensitize cancers to immune checkpoint inhibitor therapy. The objective of this study is to determine whether this drug combination is effective in shrinking cancers, keeping them from growing, helping patients live longer, and to see if the drug combination is safe.
Universitair Ziekenhuis Brussel
The main objective of this project is: 1. To assess the impact of COVID-19 on the brain and executive functioning. Twenty adult subjects of UZ Brussels (volunteers), who needed intensive care due to COVID-19 (n=10) or exhibited mild symptoms due to COVID-19 (n=10), will be recruited after hospital discharge. After signing an informed consent the subjects will undergo brain scans (T1, DTI, SWI, DWI, FLAIR MRI and rsfMRI), an emotion regulation task and a neurocognitive test battery. The latter test battery will be performed using an iPad and will test different neurocognitive functions such as memory, abstract thinking, spatial orientation and attention. The duration of the test battery is 18min. The total duration of one trial is estimated at one hour and a half. All tests are planned at the department of Radiology-Magnetic Resonance (UZ Brussel). After three months patients will visit the department of Radiology-Magnetic Resonance a second time for the same experimental trial. Additionally, a matched control group (n = 20; non covid or ICU patients) will be included and undergo the same tests in order to compare the results of the brain scans, emotional regulation task and neurocognitive test battery with results of both Covid-groups. Next to objective data, questionnaires will be filled out, i.e. visual analogue scales of mental and physical fatigue, Profile of Mood States and some additional return to work questions.
Astana Medical University
Retrospective Non-Randomized Analytical Cohort Study of Completed SARS-CoV2 COVID19 Cases