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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Displaying 110 of 224Obafemi Awolowo University
Since the outbreak of the novel coronavirus disease in 2019 (COVID-19), an unprecedented global search for potential therapeutics and vaccines is ongoing. In this study, a combination of two drugs that have been shown to be effective against the germ that causes COVID-19 in the laboratory will be tested in patients diagnosed with moderate to severe COVID-19. One of the drugs is called nitazoxanide and the second is atazanavir/ritonavir. Nitazoxanide has been used for the treatment of diarrhea since 2004 while atazanavir/ritonavir was approved for HIV treatment in 2003. They are known to be safe in humans. In this pilot study, 98 COVID-19 patients will be recruited into two groups. The 49 patients in group 1 will receive the standard of care determined by their primary care providers while the 49 patients in group 2 will receive both the standard of care combined with the two study drugs. Patients in group 2 will receive the study drugs for 14 days and all patients will be monitored for a total of 28 days. The time it takes for the germ that causes COVID-19 to be completely removed from the body (in nasal secretions) and the time to clinical improvement will be monitored in all patients and compared between the two groups.
United States Department of Defense
- This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications. - Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first. - Subjects will be randomized to receiving convalescent plasma or best supportive care. - Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. - The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.
Instituto de Medicina Regenerativa
This is a pilot phase, open label, non-randomized study for the treatment of ARDS in patients infected with COVID-19. Subjects will be enrolled and treated with one dose of mesenchymal stem cells and follow-up will occur 90 days post-treatment.
Deborah O'Connor
The Canadian Paediatric Society recommends breastfeeding during COVID-19 infection. Human milk is the best form of infant nutrition providing significant protection against many illnesses for term and preterm infants. When mothers of hospitalized infants are unable to supply their milk, the recommended supplement is human donor milk. The impact of a pandemic on human milk banking is unknown. This study seeks to address this public health issue. Donor milk will be collected from the Rogers Hixon Ontario Human Milk Bank at Sinai Health System in Toronto. Samples will be analyzed for the COVID-19 virus specific nucleic acid and antibody in real-time and results will be immediately disseminated to relevant organizations to inform local, national and international guidelines surrounding donor milk banking to protect the health of infants.
Deborah O'Connor
The Canadian Paediatric Society recommends breastfeeding during COVID-19 infection. Human milk is the best form of infant nutrition providing significant protection against many illnesses for term and preterm infants. The impact of a pandemic on breastfeeding is unknown. This study seeks to address this public health issue. Breastmilk will be collected from mothers positive for COVID-19. Samples will be analyzed for the COVID-19 virus specific nucleic acid and antibody in real-time and results will be immediately disseminated to relevant organizations to inform local, national and international guidelines surrounding breastfeeding to protect the health of infants.
Oslo University Hospital
This is a research study to see how safe and effective decidual stromal cells are in treating patients with respiratory failure (breathing problem where not enough oxygen is passed from the lungs into the blood) caused by COVID-19.
Notitia Biotechnologies Company
This open-label, randomized, and controlled clinical trial aims to determine the feasibility and effectiveness of using NBT-NM108, a novel botanical-based fixed-combination drug, to modulate the gut microbiota and treat early-stage suspected or confirmed symptomatic COVID-19 patients.
VA Office of Research and Development
The purpose of this study is to determine if treatment with convalescent plasma improves the clinical outcomes of Veterans who are hospitalized and require supplemental oxygen due to COVID-19.
National Cancer Institute (NCI)
This phase I/II trial investigates the best dose and side effects of leflunomide and how well it works in treating patients with COVID-19 and a past or present cancer. Leflunomide has been used since the 1990s as a treatment for rheumatoid arthritis. Experiments done with human cells that were given severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing COVID-19, showed that leflunomide was able to reduce the ability of the virus to make copies of itself. The coronavirus uses ribonucleic acid (RNA), a very long molecule that contains genetic information that is like a blueprint for making more copies of itself. Leflunomide inhibits the formation of RNA. The information gained from this study may help researchers to learn whether leflunomide is safe for use in treating patients with COVID-19, and whether it is potentially effective against the disease.
West Virginia University
Our overarching goal is to improve the outcomes of critically ill COVID-19 patients with or at risk for development of acute kidney injury (AKI). The objective of this study is to determine the role of a protocol to manage urine alkalization using a simple medication that has been used for a very long time, is safe, and without significant side-effects. We aim to determine the feasibility and safety of a urine alkalinization protocol for the prevention of AKI in patients testing positive for COVID-19.