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 120 of 889Centre Hospitalier Universitaire, Amiens
On January 9, 2020, a new emerging virus was identified by WHO as being responsible for grouped cases of pneumonia in China. It is a coronavirus, SARS-CoV-2, responsible for the disease COVID-19 (Coronavirus disease). The disease is mild in 85% of cases but the proportion of serious cases requiring hospitalization or intensive care (15%) puts stress on health structures and systems around the world. To limit the influx of patients and avoid overstretching Health systems, containment and social distancing strategies are widely adopted. It appears crucial to propose the easiest possible therapeutic strategy taking into account the ambulatory nature of the patients. Therefore azithromycin (AZM) is an antibiotic known to have an antiviral effect but also which has anti-inflammatory activity in addition to its antimicrobial effect. Azithromycin targets preferentially pulmonary cells (and particularly of the lines apparently affected in COVID-19 positive cases). The aim of this study is to demonstrate that AZM decreases symptom duration in COVID19 patients and diminishes the viral carriage.
Erasme University Hospital
The outbreak linked to SARS-CoV-2 pandemic resulted in lock-down measures in almost all European countries. This online survey assesses these measures implications on Mental Health in emerging adults. The questionnaires evaluate two psychometric variables (Resilience and Loneliness) and Mental Health status (mental health professional help-seeking, use of psychotropic drugs, or possible diagnosis) before and during Lock-down Measures. At least 600 healthy participants aged form 18 to 25 years old will be attended to fill the survey during the SARS-CoV2 Pandemic Lock-down Measures.
University Hospital, Toulouse
This research aims to improve knowledge of the epidemiology of patients consulting in the COvid Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID19 affects France and impacts its health system. The reception of all intermediate patients will be on the Emergency Structures (SU). Indeed, the French healthcare system centralizes unscheduled urgent care on the ER. The aspecific respiratory symptomatology in "intermediate" patients indicates them all the more at an admission to SU or the diagnostic approach to respiratory difficulty may be carried out. It will be necessary to identify the diagnosis of the dyspneic patient and to define his virological status COVID before referring him to the appropriate units. The investigatory propose an original strategy of dedicating entire care sectors to the care of patients admitted for dyspnea in our ER. These units will be named RECOP units. This study would improve epidemiological knowledge of COVID-19 and ability to receive these patients within the SU.
Université Catholique de Louvain
The project US3R is a general population survey that will measure the magnitude of utilised, postponed and foregone medical care in relation with other health care needs than coronavirus symptoms during the confinement period in Belgium. The study aims to describe the magnitude of unsatisfied health care needs for various types of care. It will also identify the reasons for these postponed and foregone care according to gender, health and socioeconomic status.
Icahn School of Medicine at Mount Sinai
The mortality rate in SARS-CoV-2-related severe ARDS is high despite treatment with antivirals, glucocorticoids, immunoglobulins, and ventilation. Preclinical and clinical evidence indicate that MSCs migrate to the lung and respond to the pro-inflammatory lung environment by releasing anti-inflammatory factors reducing the proliferation of pro-inflammatory cytokines while modulating regulatory T cells and macrophages to promote resolution of inflammation. Therefore, MSCs may have the potential to increase survival in management of COVID-19 induced ARDS. The primary objective of this phase 3 trial is to evaluate the efficacy and safety of the addition of the mesenchymal stromal cell (MSC) remestemcel-L plus standard of care compared to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2. The secondary objective is to assess the impact of MSCs on inflammatory biomarkers.
FGK Clinical Research GmbH
At present there is no approved drug treatment for Covid-19. In this study we plan to investigate if an experimental drug called IMU-838 (vidofludimus calcium) can improve your symptoms, prevent worsening that would initiate further treatments such as ventilation, and can lower your virus number if given in addition to your doctor's choice of standard therapy. We will also test if IMU-838 has any side effects and measure the level of IMU 838 in your blood. Experimental drug means that it is not yet authorized for marketing in your country. To date approximately 600 individuals have received IMU-838 (or a drug similar to IMU-838 that contains the same active substance as IMU-838) in research studies.
TASK Applied Science
A novel betacoronavirus, SARS-CoV-2, is spreading rapidly throughout the world. A large epidemic in South Africa may overwhelm available hospital capacity and healthcare resources which would be worsened by absenteeism of healthcare workers and other frontline staff (HCW). Strategies to prevent morbidity and mortality of HCW are desperately needed to safeguard continuous patient care. Bacillus Calmette-Guérin (BCG) is a vaccine against tuberculosis (TB), with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, with reported morbidity and mortality reductions as high as 70%. We hypothesize that a BCG vaccination may reduce the morbidity and mortality of healthcare workers during the COVID-19 outbreak in South Africa.
Mayo Clinic
It is unclear how COVID19 can be passed from mother to infant. The study investigators aim to collect maternal and neonatal samples from COVID19-infected pregnant women and compare them to pregnant women who have clinical indications for COVID 19 testing at the time of hospital admission but end up being COVID19 negative. Pregnant women who are either COVID19 positive or COVID19 negative with respiratory symptoms will be enrolled and followed during this study.
National Cancer Institute (NCI)
This phase I/IIa trial studies the best dose and side effects of rintatolimod and interferon (IFN) alpha-2b in treating cancer patients with COVID-19 infection. Interferon alpha is a protein important for defense against viruses. It activates immune responses that help to clear viral infection. Rintatolimod is double stranded ribonucleic acid (RNA) designed to mimic viral infection by stimulating immune pathways that are normally activated during viral infection. Giving rintatolimod and interferon alpha-2b may activate the immune system to limit the replication and spread of the virus.
University of Pittsburgh
The purpose of this study is to perform a secondary analysis of pre-existing de-identified limited datasets obtained from sites participating in Tier 1 (STUDY20040154: Neurologic Manifestations of COVID 19 in Children) and Tier 2 (STUDY20040278: Neuro COVID - Outcomes). The data will be used to determine the prevalence and severity of neurological symptoms among patients requiring critical care admission for confirmed or suspected novel coronavirus (COVID-19) and to determine the predictors for limitation of care in the study population, as well as, the prognosis of neurologically injured patients admitted to the ICU during the COVID-19 crisis. This study is sponsored by the Pediatric Neurocritical Care Research Group (PNCRG) and sponsored and funded in part by the Neurocritical Care Society.