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.
Search Tips
To search this directory, simply type a drug name, condition, company name, location, or other term of your choice into the search bar and click SEARCH. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (e.g., “acute respiratory distress syndrome” or “ARDS”). You may opt to further streamline your search by using the Status of the study and Intervention Type options. Simply click one or more of those boxes to refine your search.
Displaying 250 of 383Instituto Brasileiro de Osteopatia
Background: Fatigue is among the most common symptoms of the long-term effects ofcoronavirus (long COVID). This study aims to compare the effectiveness of osteopathicmanipulative treatment (OMT) combined with physiotherapy treatment (PT) compared to PTalone on fatigue and functional limitations after two months post randomization in adultswith long COVID.Methods: This is a study protocol for a two-arm, assessor-blinded, pragmatic randomizedcontrolled superiority trial. Seventy-six participants will be randomly allocated toOMT+PT or PT. The PT includes usual care interventions including motor and respiratoryexercises targeting cardiorespiratory and skeletal muscle functions. The OMT entailsdirect, indirect, visceral, and cranial techniques. Patients will be evaluated before andafter a 2-month intervention program, and at 3-month follow-up session. Primaryobjectives comprise fatigue and functional limitations at 2-month post randomization asassessed by the fatigue severity scale and the Post-COVID Functional State scale.Secondary objectives comprise fatigue and functional limitations at 3 months, and theperceived change post-treatment as assessed by the Perceived Change Scale (PCS-patient).
Fondation 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.
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
Brno University Hospital
Administration of systemic corticosteroids for patients with severe forms of severe acuterespiratory syndrome(SARS-Co-2) infection are recommended by several guidelines. In thevery beginning of SARS-Co-2 pandemic the early recommendation by professionalorganization was against routine use of corticosteroids for patients with coronavirusdisease 2019 (COVID-19) acute respiratory distress syndrome (ARDS), despite previous dataand clinical practice for patients with refractory or severe form of ARDS.
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.
Aventyn, Inc.
Researchers are creating real-time epidemiology registry to evaluate the efficacy ofCOVID-19 subject risk assessment scores based on recording of symptoms, biomarkers,chronic illness and mental health assessments with digital technology using wearables andmobile app tools. Researchers aim to study in Phase 1, epidemiological variations inCOVID-19 presentation in both PCR positive and negative subjects in the registry.Assessment of variables, predictive modeling of variables that impact severity ofCOVID-19 positive and negative subjects and assessment of predictors for post COVID-19complications. In Phase 2, 2700 subjects with COVID-19 positive test will be studied inthe intervention group comparing ECL-19 vs placebo with primary end point of hospitaladmission assessment. Treatment strategy for PCR positive COVID-19 subjects in theregistry who are in Stage I of the disease process with ECL-19 drug compared to placeboin reducing hospital admissions
University Hospital Schleswig-Holstein
COVID-19 is a novel disease caused by SARS-CoV-2 that primarily affects the lungs butalso various other organs of the body already in early stages of the disease. Due to themultiple organ involvements in the acute phase, it is conceivable that - in a significantproportion of patients - longterm sequels in various organ systems might occur, therebyimpacting the individual's health status and quality of life; and posing a relevantburden to the resources of the health care systemAssessment of SARS-CoV-2-longterm morbidity and sequels on the population level:In order to identify and treat these sequels in a timely fashion and to get a sense ofthe prevalence of such SARS-CoV-2 sequels on the population level, it is important tocollect follow-up data and to comprehensively re-examine a population-representativesample of SARS-CoV-2 infected individuals.Within the COVIDOM study we will conduct deep clinical and biochemical phenotyping inpopulation-representative samples in Germany. This will allow novel insights into diseasepathogenesis and chronicity of virus infections.
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.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Background:Viral infections such as COVID-19 may lead to flare-ups in people with systemicautoimmune diseases (SAD). These infections may also change the function of their immunesystem and/or cause problems with their blood vessels. Researchers want to learn howpeople with SAD respond to treatments or vaccines for COVID-19.Objective:To understand how COVID-19 affects inflammation, the immune system, and blood vessels inadults and children with autoimmune diseases.Eligibility:People ages 15 and older who have been diagnosed with an autoimmune disease or are ahealthy volunteerDesign:Participants will have a screening visit. This will include:Medical history and physical examEKGChest x-rayCOVID-19 test. A swab will be put in the participant s nose or the back of their mouth.Blood and urine testsParticipants will be placed into 1 of 4 groups: 1. Those with previously documented COVID-19 infection or COVID vaccination 2. Those with a recently known COVID-19 exposure or vaccination 3. Those with no known COVID-19 exposure or vaccination 4. Those who developed an acute COVID-19 infectionDepending on their group, participants will have 1 to 5 more visits. These will occurover 12 to 18 months. Visits may include:FDG PET/CT scan. Participants will lie in a doughnut-shaped machine. The machine createspictures of the body. For the scan, they will have a radioactive substance injected intotheir arm through an IV.Kidney function testsNon-invasive vascular studies test. These tests are similar to what it feels like to haveblood pressure checked.
Pregistry
The objective of the COVID-19 Vaccines International Pregnancy Exposure Registry(C-VIPER) is to evaluate obstetric, neonatal, and infant outcomes among women vaccinatedduring pregnancy with a COVID-19 vaccine.Specifically, the C-VIPER will estimate the risk of obstetric outcomes (spontaneousabortion, antenatal bleeding, gestational diabetes, gestational hypertension,intrauterine growth restriction, postpartum hemorrhage, fetal distress, uterine rupture,placenta previa, chorioamnionitis, Caesarean delivery, COVID-19), neonatal outcomes(major congenital malformations, low birth weight, neonatal death, neonatalencephalopathy, neonatal infections, neonatal acute kidney injury, preterm birth,respiratory distress in the newborn, small for gestational age, stillbirth, COVID-19),and infant outcomes (developmental milestones [motor, cognitive, language,social-emotional, and mental health skills], height, weight, failure to thrive, medicalconditions during the first 12 months of life, COVID-19) among pregnant women exposed tosingle (homologous) or mixed (heterologous) COVID-19 vaccine brand series from 30 daysprior to the first day of the last menstrual period to end of pregnancy and theiroffspring relative to a matched reference group who received no COVID-19 vaccines duringpregnancy.