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 30 of 68Genentech, Inc.
This single arm, multicenter study provides the pertuzumab and trastuzumab fixed-dose combination formulation for subcutaneous injection (PH FDC SC) administered at home by a home health nursing provider for patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer who have completed concurrent chemotherapy with pertuzumab (Perjeta) and trastuzumab (Herceptin) by intravenous administration (P+H IV) and are currently receiving or will be receiving maintenance therapy with P+H IV, PH FDC SC, or trastuzumab SC in the clinic. The main objective is to enable continuity of care during the COVID-19 pandemic. This study will enroll approximately 200 patients in the United States. Participants with early or metastatic HER2+ breast cancer will be enrolled in this study. Participants with metastatic HER2+ breast cancer will receive treatment every 3 weeks and continue treatment unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity, participant withdrawal of consent, or per physician's recommendation. Participants with early HER2+ breast cancer will receive PH FDC SC to complete 1 year (up to 18 cycles) of dual blockade, including the P+H IV, PH FDC SC, or trastuzumab SC they received prior to enrolling in this study, unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity, participant withdrawal of consent, or per physician's recommendation. A remote cardiac surveillance substudy will be optional for patients enrolled at select sites. The Sponsor may decide to terminate the study when the COVID-19 pandemic is no longer a risk for this patient population.
Kaohsiung Kai-Suan Psychiatric Hospital
The Coronavirus disease 2019 (COVID-19) had its outbreak in late 2019 in China and is considered a biological disaster. With medical organizations and staff on the frontline, the investigators should conduct assessments, for the different tiers of medical staff, patients, and community residents, on the short- term psychological and mental disabilities or danger factors that they might have faced. As such, the investigators can design and establish a set of evaluative indicators of the risks of biological disasters, and strategies to manage guide and cope, and internal/ external testing strategies. These work in guaranteeing quality and performance, and as such, establishing "Digital Platform for Integrated Research of Coronavirus disease 2019 (COVID-19)".
Egyptian Military Medical Services
The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant for treatment and to assess the potential in reducing mortality and morbidity rates in COVID-19 patients. The study was approved by the ethical committee of the Egyptian Center for Research and Regenerative Medicine in 11-5-2020.
Duke University
CovIdentify is a research initiative to promote early detection of COVID-19 infections from wearable device data. CovIdentify will primarily be a feasibility study to explore the potential of wearables to detect COVID-19 infection. The investigators will refine our previous statistical and machine learning-based anomaly detection algorithms toward COVID-19 detection using personalized models of health and detect deviations indicative of infection. The investigators will validate and test specificity and sensitivity of the models for detecting COVID-19 infection vs. non-infection against symptom surveys and COVID-19 test results and hospital admissions data.
Regeneron Pharmaceuticals
Compassionate Use requests will be considered for individuals who test positive for SARS-CoV-2 and where there is reasonable basis to believe that the patient is infected with a susceptible variant.
Larkin Community Hospital
The purpose of this study is to assess the efficacy of Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray as an adjunct treatment of COVID-19.
The Alfred
Patients who are critically ill in intensive care with moderate to severe acute respiratory infection often require mechanical ventilation. Prolonged ventilation increases the risk of lung damage and other side effects as a result of long term use of sedation medications. Extracorporeal membrane oxygenation therapy (ECMO), is a relatively new technology that uses a pump to remove blood from the body and return it back to the body after adding oxygen and removing carbon dioxide. ECMO can be used on patients who require mechanical ventilation and can function without the need for ongoing mechanical ventilation, thus reducing risk of side effects. Participants will be randomised into either the early ECMO therapy group or will continue standard treatment involving mechanical ventilation. This pilot study aims to determine if a phase 3 Randomised Control Trial (RCT) is feasible for the use of early ECMO therapy to treat patients with Severe Acute Respiratory Infection (SARI). The success of the study will be determined by the successful recruitment of adult patients, that there is a difference between ECMO utilisation between groups and that there are no safety issues.
Iran University of Medical Sciences
The aim of this study is to investigate efficacy of internet based pulmonary rehabilitation and progressive muscle relaxation program on functional capacity, depression and anxiety, dyspnea, fatigue, sleep quality and quality of life in covid19 patients after hospital discharge
International Centre for Diarrhoeal Disease Research, Bangladesh
COVID -19, first reported in Wuhan, China, strikes the world hard as a pandemic by spreading up to 213 countries. Bangladesh is also facing its havoc with the death of 3000 among 229,185 cases at its 141st day. Most are mild cases presenting with influenza-like illness with expected recovery. According to World Health Organization, the overall global case fatality rate is currently estimated to be 2.9%. However, patients having severe or critical illness presenting with severe respiratory distress, ARDS or shock suffer most with mortality rates of 49.0-61.5%. Studies suggest that there are mild or severe cytokine storms in severe patients, which is an important cause of death. An exaggerated and uncontrolled release of pro-inflammatory mediators by an overly activated immune system is known as cytokine storms (CS) or cytokine release syndrome (CRS) which has an important role in the hemodynamic insults seen in very ill COVID-19 patients. This aberrant release of pro-inflammatory cytokines causes lung damage, myocarditis, acute kidney injury, etc. In this study, the investigators aim to estimate the burden of cytokines and their correlation with the magnitude of the severity of COVID-19 illness in Bangladeshi adults.
University of Florida
This is a phase II study to test adenosine efficacy for down-regulation of the overwhelming inflammation of COVID-19 in the lungs as reflected by clinical recovery of lung function; resolution of clinically relevant markers of lung function, and resolution of systemic markers of inflammation and coagulation.