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 90 of 330Amarin Corporation
MITIGATE is a prospective, open-label, parallel-group, randomized, pragmatic clinical trial. The MITIGATE Study has been designed to evaluate the real-world clinical effectiveness of pre-treatment with icosapent ethyl (IPE), also known as Vascepa®, compared to usual standard of care to prevent and reduce the sequelae of laboratory-confirmed viral upper respiratory infection (URI)-related (i.e., COVID-19, influenza, and other known viral respiratory pathogens) morbidity and mortality in a high-risk cohort of adults with established atherosclerotic cardiovascular disease (ASCVD).
University of Utah
The purpose of this study is to explore the effectiveness of processed human amniotic fluid as a treatment for COVID-19.
National Institute of Allergy and Infectious Diseases (NIAID)
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.
Climate Foundation
At least 1 in 6 COVID-19 patients admitted to hospital to receive extra oxygen will die of complications. In patients with COVID-19, invasive treatment such as mechanical ventilation (e.g. breathing with a machine) is associated with a 50% increased risk of death. Invasive treatments use a lot of healthcare resources in intensive care units and may lead to further deaths if patients do not have access to care. The investigators aim to improve outcomes for COVID-19 patients by implementing hyperbaric oxygen therapy (HBOT). HBOT allows patients to breathe 100% oxygen in a special chamber at a pressure higher than sea level. It is approved by Health Canada for 14 conditions. HBOT is safe when administered by experienced teams. There are two main causes of death in severe COVID-19 respiratory infections: (i) a decreased diffusion of oxygen from the lungs to the blood and (ii) an increased inflammatory response (also called a "cytokine storm"). HBOT leads to increased oxygen level in blood, has strong anti-inflammatory effects, and may destroy the virus responsible for COVID-19 disease. The initial experience with HBOT and COVID-19 from China, France and the United States is promising in that it prevents further worsening of the condition and need for intensive care. The investigators propose to test the effectiveness of HBOT for COVID-19 patients who are admitted to hospital to receive extra oxygen. Using the most rigorous and innovative research methods, this Canadian-led international study will operate at 5 centers across 3 countries (Canada: Ottawa, Toronto, Edmonton; Switzerland: Geneva; UK: Rugby/London). The investigators anticipate that when treated by HBOT, COVID-19 patients needing extra oxygen to breathe will see significant health improvements as well as a decrease in complications, inflammation in the blood, need for invasive care, death, and cost of care.
Institute of Progressive Medicine
Preliminary reports have been received from several sources that the periodic inhaling of the nebulized mist from water that has a heightened level of kinetic activity has quickly (less than 2 days) lessened the severity of symptoms in Covid-19 infected patients. On at least several occasions, a repeat PCR test performed several after inhaling a particular water-based product was negative. There are no perceived adverse effects from inhaling the water mist by using a nebulizer or humidifier. It is important, however, to validate these preliminary findings and to include the inhaling of the mist from water, which does not have an elevated level of kinetic activity. This will be by performed in a patient-blinded manner by sequentially inhaling the two types of water over consecutive 2-day periods with Covid-19 testing at the end of each of the two day periods. Participants will be randomized as to whether they are to inhale the mist from the test or the control water.
Restem, LLC.
ULSC-CV-01 is a clinical trial that comprises both Phase 1 and Phase 2a, which will be conducted sequentially. This trial will evaluate the safety and potential efficacy of allogeneic Umbilical Cord Lining Stem Cells (ULSC), which are a type of umbilical cord tissue derived mesenchymal stem cells (MSC), with intravenous (IV) administration in hospitalized patients with acute respiratory distress syndrome (ARDS) due to COVID-19.
French Society of Rheumatology
Accurate knowledge of the humoral immune responses induced by SARS-CoV-2 in patients undergoing immunosuppressive therapy is essential to guide recommendations for infected patients and for vaccination policy for uninfected immunosuppressed patients.
Imperial College London
TITLE EARSATS-19: In-ear measurement of blood oxygen saturation in COVID-19 follow up DESIGN Non-inferiority study AIMS To evaluate qualitative and quantitative performance of in-ear SpO2 monitoring against the gold standard right finger-clip pulse oximeter -- towards validation for use in COVID-19 in the acute ambulatory and long-term monitoring setting OUTCOME MEASURES In-ear SpO2 compared with gold-standard finger-clip pulse oximeter: Correlation between SpO2 measurements at rest Correlation between SpO2 measurements during 6 minute walk test Signal quality during 6 minute walk test Qualitative evaluation of clinical and patient user acceptability using questionnaires POPULATION 30 patients attending COVID-19 follow-up clinic and 30 patients with chronic lung disease attending routine outpatient investigations ELIGIBILITY Aged 18 and above, no upper age limit Able to give informed consent No abnormal ear anatomy. DURATION 12 months
ClinAmygate
Time to recover of Anosmia and / or ageusia and early corticosteroid use
Nature Cell Co. Ltd.
This study is an open-label, single-arm study to evaluate the safety and efficacy of Astrostem-V, allogenic adipose tissue derived mesenchymal stem cells (AdMSC), in patients with COVID-19 pneumonia. After each subject completes 12-Weeks visit (Visit 12) and the data management team confirms all individual data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.