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 890 of 1143Kine Kinesiologia Deportiva y Funcional
Research describing training load management during COVID-19 enforced home training in professional tennis players is lacking. Therefore, the main objective of this case series is to describe in detail the training load management and progression of three professional tennis players before, during and after COVID-19 pandemic lockdown.
University of British Columbia
This study is a randomized controlled trial of an online, evidenced-based intervention (the ENHANCE program) that was modified to address the health and well-being challenges of COVID-19. Eligible participants will be randomized into the ENHANCE or Wait-List Control group over a 12-week period. ENHANCE participants will be introduced, and asked to practice, 10 evidenced-based principles and skills of happiness and well-being. Participants will complete an online survey about their health and well-being at baseline, midway (or 6 weeks), post-assessment (or at the end of the 12-week study), and 3-months following the end of the study.
Vastra Gotaland Region
Paroxysmal atrial fibrillation (AF) induce, in the affected patient, a prominent negative effect on health-related quality of life (HR-QoL) and physical fitness. The health care utilisation is high and the patient does never know when the next attack of atrial fibrillation occurs. Therefore, is physical exertion often avoided due to fear of new attacks. Further, are shortness of breath and fatigue often present despite of prescribed modern drugs. Paroxysmal AF per se enhance markedly the risk to develop stroke and heart failure, which both are syndromes that cause further negative effect on the patient´s HR-QoL and physical fitness. Altogether, cause the symptoms in paroxysmal AF a vicious spiral where both VO2max and muscle function deteriorate. The problems with shortness of breath might be due to dysfunction in respiratory muscles. Physiotherapy led exercise within cardiac rehabilitation (PT-X) in combination with inspiratory muscle training (IMT) has shown positive effects in patients with permanent atrial fibrillation. However, to our knowledge, not yet investigated in patients with paroxysmal AF. Aim: Primary to investigate, in a multicentre randomised controlled trial, if PT-X in combination with IMT can impact HR-QoL in patients with paroxysmal AF. Secondary to investigate the effect of PT-X in combination with IMT regarding symptoms, physical fitness, physical activity and the number of atrial fibrillation attacks and health care costs compared to the control group, asked to live their usual life, during the study period. Expected outcome: PTX in combination with IMT can improve HR-QoL, respiratory muscle function, level of symptoms, physical fitness and physical activity in patients with paroxysmal AF. In addition, a reduced number of atrial fibrillation attacks could decrease the direct cost of health care.
ContraFect
This is an open-label, expanded access study of exebacase used in addition to antistaphylococcal antibiotics in adult patients with persistent methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections (BSI), including right-sided endocarditis (R-IE), who are hospitalized with coronavirus disease 2019 (COVID-19). Patients with left-sided endocarditis (L-IE) are excluded. Patients will receive a single dose of exebacase. Patients will continue to receive antistaphylococcal antibiotics as prescribed by the treating physician. Exebacase Phase 3 study sites (Study CF-301-105) may participate in this Expanded Access study (Study CF-301-107). Exebacase, a direct lytic agent, is an entirely new treatment modality against S. aureus. Exebacase is a recombinantly-produced, purified cell wall hydrolase enzyme that results in rapid bacteriolysis, potent biofilm eradication, synergy with antibiotics, low propensity for resistance, and the potential to suppress antibiotic resistance when used together with antibiotics. Exebacase represents a first-in-field, first-in-class treatment with the potential to improve clinical outcome when used in addition to standard-of-care antibiotics to treat S. aureus BSI including IE.
AbCellera Biologics Inc.
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
NeuroBo Pharmaceuticals Inc.
Study of ANA001 in Moderate and Severe COVID-19 Patients
AgelessRx
Study into the effects of daily use of metformin and low-dose naltrexone (LDN) for 4 weeks to reduce symptoms, disease severity, and recovery time from COVID-19.
Ohio State University
Researchers know that the virus that causes COVID-19 has been found in the saliva (spit) of individuals who exhibit signs of the disease. Investigators would like to test the ability of three mouthwashes to reduce the levels of this virus in participants' mouths. Investigators will ask participants to use a liquid to swish around in the mouth for 30 seconds and spit it into a collection cup. Investigators will also collect spit from participants before and after participants use the mouthwash. Although participants will have no direct benefits from the study, investigators will gain a wealth of information that would benefit patients who are at risk for COVID-19.
Clinica Universidad de Navarra, Universidad de Navarra
Patients requiring hospitalization due to COVID-19 pneumonia (non-severe) will be randomized to standard prophylactic doses or full therapeutic dose of bemiparin (a LMWH) for 10 days.
Dasman Diabetes Institute
Approximately 10-15% of patients infected with COVID-19 develop severe illness characterized by respiratory distress, increased risk of clotting disease, myocardial damage, stroke and mortality. Subjects with Type 2 diabetes (T2DM) are at increased risk for severe COVID-19 disease. Exuberant inflammatory and immune responses were suggested as the etiology responsible for the development of severe COVID-19 disease. The increased chronic inflammatory state characteristic of T2DM could contribute to the increased risk of severe COVID-19 disease in T2DM patients. Therefore, its possible that anti-inflammatory therapy will reduce the risk of severe COVID-19 disease. Consistent with this assumption, a recent study has reported that steroid therapy improves the outcome in patients with severe COVID-19 disease. The medication pioglitazone is a strong insulin sensitizer that reduces plasma glucose concentrations in T2DM patients. In addition to improving insulin sensitivity, several studies have demonstrated that pioglitazone reduces chronic inflammation in T2DM patients, which is manifested in a decrease in TNF-alpha, interleukin, hs CRP, leptin and other inflammatory markers in T2DM treated with pioglitazone. Further, pioglitazone enhances the plasma level of anti-inflammatory agents. For example, the plasma level of 15-epi-lipoxin A, a lipid mediator with strong anti-inflammatory and inflammation-resolving effects that has been reported to neutralize RNA coated viruses, is significantly elevated by pioglitazone treatment in T2DM patients. Therefore, we hypothesize that administering pioglitazone to T2DM patients who have moderate-to-severe COVID-19 will improve the clinical outcome of their COVID-19 disease.