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 240 of 370Fondation Hôpital Saint-Joseph
SARS-CoV2 is responsible for a pandemic that has been evolving for approximately 18months. The virus' capacity for dissemination and its virulence are responsible forsignificant morbidity and mortality. The initial lack of knowledge of the pathogen and ofthe pathophysiology underlying the potential severity of the disease, particularly in therespiratory tract, led to numerous therapeutic attempts in this emergency context,centered on the control of an obviously exaggerated inflammatory response. A large numberof studies remained of insufficient quality to lead to relevant and applicableconclusions. Secondly, the benefit of corticosteroid therapy has been demonstrated in twotrials. Although Dexamethasone remains the only corticosteroid to improve survival, theseresults have reinforced the hypothesis of the interest of treatments reducing theinflammatory response, particularly cytokine. The widespread use, in the absence ofscientific data, of interleukin-6 receptor inhibitors (Sarilumab and Tocilizumab) hasbeen structured around studies whose results remain uncertain to this day because of theheterogeneity of the population treated and the results observed. A possible survivalbenefit seems to emerge for resuscitation patients who have not yet required invasiveventilation, the other situations being probably associated with the absence of effect oreven the potential danger of this treatment. Tocilizumab is notably associated in theliterature with the risk of secondary infections and mucosal healing abnormalities,favoring bleeding complications and digestive perforations. The objective of this studyis to evaluate the risk of digestive complications (hemorrhage, perforation,diverticulitis) and infectious complications related to the use of Tocilizumab accordingto the severity of the patients.
University of Ottawa
In March 2020, the World Health Organization (WHO) declared the novel coronavirus(COVID-19) a global pandemic. Ontario has confirmed more than 547,000 cases of COVID-19since testing began. For many of these patients, symptoms resolve within 4 weeks ofonset. However, it is becoming apparent that a significant number of individuals areexperiencing symptoms that persist long after the acute infection, known as Long COVID.These individuals have a wide constellation of presenting symptoms, often varying frominitial presentation. For this study, we will be enrolling individuals receiving care atThe Ottawa Hospital for Long COVID. This study aims to determine the following fourthings: 1) will adding electronic case management improve quality of life three monthsafter coming to hospital with Long COVID; 2) is the electronic case management platformcost effective; 3) is there any factors that predict outcomes at 3 months; 4) todetermine how a personalized rehabilitation program supported by a digital platform couldbe implemented for individuals with Long COVID. We will enroll individuals from TheOttawa Hospital who will then be randomly assigned to receive either usual care or usualcare plus electronic case management, through a platform called NexJ Connected Wellness.Participants will also complete questionnaires every 4 weeks for 3 months. We will belooking at quality of life, mental and physical health, cognitive symptoms, fatigue andpain.
Medical University Innsbruck
Wider research context: Since the recognition of SARS-CoV-2 outbreak in 2019, there arenow over 126 million COVID-19 cases worldwide with more than 2.7 million deaths. Reportson neurological manifestations vary in prevalence rates (6-84%) and range from mild(headache, hyposmia, myalgia) to severe (encephalopathy, strokes, seizures). Little isknown about long-term neurological outcomes of COVID-19 patients. The investigatorspropose a structured protocol to capture persistent and delayed neurologicalmanifestations, neurocognitive deficits and quality of life (QoL) 3 and 12 months afterCOVID-19. Objectives: The investigators hypothesize that neurological manifestations andneuropsychological/cognitive deficits can be detected after COVID-19, substantiallyimpact on patients' QoL and can be correlated with structural neuroimaging findings. Mainobjectives are to assess firstly long-term prevalence rates and natural history ofneurological manifestations, secondly neuropsychological/cognitive deficits afterCOVID-19, thirdly the impact of COVID-19 on measures of mental health, QoL and functionaloutcome, fourthly to correlate neurological manifestations and distinct neurocognitivedeficits with structural MRI abnormalities, and Fifthly to compare these results to age-and sex matched controls hospitalized with pneumonia (Cpneum) and to healthy controls forMRI-data (Chealthy). Approach: The investigators aim to enrol at least 225 patients withCOVID-19, in addition to 50 Cpneum and 80 Chealthy. COVID-19 patients will include (groupOóne) outpatients presenting to the hospital, (group two) in-patients not requiring ICUadmission, and (group three) patients admitted to the ICU. The investigators will notinclude asymptomatic patients, patients not presenting to the hospital, and those who donot consent to participate. The standardized protocol includes a firstly a structuredneurological examination, secondly olfactory testing, thirdly assessment of QoL, mentalhealth and functional outcome at 3 and 12 months, and fourthly screening for cognitivedeficits (at 3 months) and a structured neuropsychological testing (at 12 months) inCOVID-19 patients and controls. In a subset of at least 120 COVID-19 patients and 50controls (Cpneum) high field MRI will be performed at 3 and 12 months. Innovation: Theinvestigators aim to quantify COVID-19 related and specific neurological manifestationsand their impact on the individual health condition. The novelty lies in the prospectivedesign, the longitudinal follow-up including and the inclusion of a control group whichallows us to explore the natural history of COVID-19 related neurological manifestations.Preliminary analysis of our ongoing 3-month follow-up suggests persistent neurologicalmanifestations and a significant impact of COVID-19 on mental health, cognition and QoL.The investigators believe that our study results likely influence the long-term care ofCOVID-19 patients and help to identify those, who need further neuro-rehabilitativesupport
Nemours
This is a prospective cohort study of pregnant patients at an urban academic centerdiagnosed with perinatal COVID-19 infection, followed up to 6 weeks postpartum.
University of Kansas Medical Center
The purpose of this study is to evaluate pulmonary function of patients recovering frommild, moderate, and severe COVID-19 disease using hyperpolarized 129Xe MRI.
Corporacion Parc Tauli
The purpose of this study is to characterize microvascular reactivity on the forearmmuscle using non-invasive near-infrared spectroscopy in critically ill COVID-19 patients,and to correlate its alterations with 28-day mortality in ICU COVID-19 patients.
Memorial Sloan Kettering Cancer Center
The purpose of this study is to collect information that will help the reasearchers learnmore about COVID-19 infections in cancer patients, and to find out about the effects ofthese infections on cancer treatment and outcomes. The research study involves askingpeople to complete a series of online questionnaires that include questions about theirmedical history, lifestyle, and risk factors related to the COVID-19 infection. The studywill enroll both MSK patients and their household family members.
McGill University Health Centre/Research Institute of the McGill University Health Centre
To evaluate if omalizumab is effective in decreasing mortality in severe hospitalizedCOVID-19 cases.
Cold Spring Harbor Laboratory
The overall objective of this study is to evaluate the clinical efficacy of oralfamotidine in symptomatic non-hospitalized patients with confirmed COVID-19. This studyis expected to enroll up to 84 patients with mild to moderate symptoms divided into eachof the two study arms. Clinical outcomes of the two treatment arms will be compared. Thisstudy will be conducted virtually/remotely.
Department of Health and Human Services
This is a prospective single-center study for the follow-up of SARS-CoV-2 positivepatients in the district of Konstanz (LKN). As part of the coronavirus pandemic, patientswith SARS-CoV-2 infection are currently being treated in the clinics of the LKN's healthnetwork at the Singen (Hegau-Bodensee Clinic) and Konstanz (Konstanz Clinic) locations.So far, there is little data on the long-term effects of SARS-CoV-2 infection. As part ofthis study, the disease progression of these patients will be monitored. Study objective:Prospective, controlled follow-up observation of SARS-CoV-2 positive patients regardingtheir secondary diseases and quality of life.