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Home
  • About
      1. Board of Directors
      2. Our Staff
      3. Annual Reports
      4. Policies
      5. Fellowship
      6. Careers
  • Projects
      1. Column 1
        1. Advancing Regulatory Science
          1. Oncology Multi-Regional Clinical Trials
          2. Rare Disease Innovation Roundtable
        2. Animal Health & Veterinary Medicine
          1. Antimicrobial Use in Food Animals
          2. Cross-Sectoral Health Threats
          3. Industry SWOT Analysis
        3. Expanded Access
          1. E-request App
          2. Navigator
          3. Resources for COVID-19
        4. FDA Patient Listening Sessions
      2. Column 2
        1. Food & Nutrition
          1. About
          2. Food Traceability
          3. Healthy Rule Roundtables
          4. Nutrition Facts Label
          5. Produce Safety Stakeholder Dialogue
          6. Retail Dietitian Toolkit
        2. Improving Access to FDA Information
          1. Understanding FDA & FDA-Regulated Products
          2. Improving Access to Publicly Available FDA Information
        3. Research
          1. About
          2. IMEDS
          3. Post Market Research
          4. RAISE
          5. Real World Data
          6. Regulatory Science Accelerator
      3. Substance Use Disorders
  • News and Events
      1. Innovations in Regulatory Science & Policy Awards
      2. Events
      3. News
      4. Publications
      5. 2026 Annual Public Meeting
  • Expanded Access eRequest
  1. Home

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.

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 430 of 530

Quadram Institute Bioscience

COVID-19 Persistence in Stool

Conditions: SARS-CoV Infection

This is a longitudinal study in which participants that have been confirmed by a NationalHealth Service (NHS) swab test as COVID-19 positive will be asked to provide faecal andsaliva samples, and complete short health/lifestyle questionnaires at the time ofsampling (referred to as a sample set). The number of sample sets collected from anyparticipant will be dependent on how long the SARS-CoV-2 virus persists within the stool.The investigators aim to collect a minimum of 4 and a maximum of 8 sample sets, and willtarget all COVID-19-positive subjects, with the exception of those severally ill (e.g. inthe intensive care unit (ICU)). The investigators aim to recruit a minimum of 100 and upto 200 participants. To obtain the desired numbers, it may be necessary to continuerecruitment during any further United Kingdom (UK) COVID-19 infection peaks.

Centre Hospitalier Universitaire, Amiens

Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients

Conditions: COVID19, Neurological Manifestations, Brain Damage

Viral pandemics, such as HIV and SARS-Cov-V1, have shown that they can lead to acute and/ or delayed neurological complications. At the actual context of the pandemicCoronavirus disease 2019 (COVID-19), neurological manifestations seem to be confirmedsince in 85% of COVID-19 patients, present neurological symptoms, including anosmia,ageusia, periorbital pain, dizziness, fatigue, even moderate headache, moderate memoryand/or behavioral disorders.However, these neurological manifestations are not well studied and their radiologicalfeatures are not well described. It is therefore important to assess these potentialneurological complications in COVID-19 patients. To the investigator knowledge, there isno previous study in the literature describing spectral brain changes in COVID +patients. Thus, the goal of this work is to describe the radiological semiology using MRIand particularly Magnetic Resonance Spectroscopic (MRS) biomarkers in the evaluation ofacute and / or delayed brain damage in COVID + patients presenting a neurologicalmanifestations that are initially related to the cranial nerves damage.

Australian National University

Nebulised Heparin in Patients With Severe COVID-19

Conditions: COVID19, Respiratory Failure

The Can nebulised HepArin Reduce morTality and time to Extubation in Patients withCOVID-19 Requiring mechanical ventilation Meta-Trial (CHARTER-MT) is a prospectivecollaborative individual patient data analysis of randomised controlled trials and earlyphase studies. Individual studies are being conducted in multiple countries, includingAustralia, Ireland, the USA, and the UK.Mechanically ventilated patients with confirmed or strongly suspected SARS-CoV-2infection, hypoxaemia and an acute pulmonary opacity in at least one lung quadrant onchest X-ray, will be randomised to nebulised heparin 25,000 Units every 6 hours orstandard care (open label studies) or placebo (blinded placebo controlled studies) for upto 10 days while mechanically ventilated. All trials will collect a minimum core dataset.The primary outcome for the meta-trial is ventilator-free days during the first 28 days,defined as being alive and free from mechanical ventilation. Individual studies may haveadditional outcomes.

Dr. Negrin University Hospital

Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions

Conditions: Acute Hypoxemic Respiratory Failure

Background: There are no proven therapies specific for pulmonary dysfunction in patientswith acute hypoxemic respiratory failure (AHRF) caused by infections (includingCovid-19). The full spectrum of AHRF ranges from mild respiratory tract illness to severepneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. Theefficacy of corticosteroids in AHRF and ARDS caused by infections remains controversial.Methods: This is a multicenter, randomized, controlled, open-label clinical trial testingdexamethasone in mechanically ventilated adult patients with established AHRF (includingARDS) caused by confirmed pulmonary or systemic infections, admitted in a network ofSpanish ICUs. Eligible patients will be randomly assigned to receive dexamethasone:either 6 mg/d x 10 days or 20 mg/d x 5 days followed by 10 mg/d x 5 days. The primaryoutcome is 60-day mortality. The secondary outcome is the number of ventilator-free daysat 28 days. All analyses will be done according to the intention-to-treat principle.

Boehringer Ingelheim

Nintedanib for the Treatment of SARS-Cov-2 Induced Pulmonary Fibrosis

Conditions: SARS-Cov-2 Induced Pulmonary Fibrosis

Currently, there is no approved treatment for COVID-19 in France, either for the acutephase, nor for the late chronic phase. the investigator suggest that nintedanib has thepotential to block the development of lung fibrosis when initiated early enough toinhibit the activation of mesenchymal cells and the progression of virus-inducedpulmonary fibrosis. Computerized Tomography (CT) manifestations of fibrosis or fibrousstripes are described in COVID-19 (Ye, Eur Radiol 2020). Pan et al observed fibrousstripes in 17% patients in the early phase of the disease (Pan, Eur Radiol 2020). Ye etal observed bronchiectasis in 2 patients (15.4%) and evidence of pulmonary fibrosis in 3patients (23.7%) at HRCT performed at 4 weeks (Ye, Eur Radiol 2020). Long term data arestill lacking in patients with COVID-19 and the investigators do not know how manypatients will have fibrotic sequelae from the acute illness.

CMN "20 de Noviembre"

Estrogen Therapy in Non-severe COVID-19 Patients

Conditions: COVID-19

The primary objective of this study is to evaluate the effect of additional estradiolestrogen therapy on clinical response and mortality in non-severe COVID-19 patients

University Hospital, Clermont-Ferrand

Influence of the COVId-19 Pandemic on STRESS, and Screening Procedures (COVISTRESS Screening)

Conditions: COVID-19 Screening

Coronavirus has caused containment of more than a third of the world's population. Somecountries have used a major screening strategy. Screening procedures, such as waiting (orresulting) for the test, can be stressful and can attract the most stressed people.However, there is currently no data on the relationship between stress and screening forSARS-CoV2

La Tour Hospital

Impact of COVID-19 Outbreak on Non-COVID-19 Patients

Conditions: COVID-19

The Geneva Canton organized the health crisis of the COVID-19 epidemic around the care ofCOVID patients at the University Hospital (HUG), by moving the care of non-COVID patientsto private hospitals of the canton. The COVID epidemic appears to have been associatedwith a decrease in consultations and care for non-COVID patients. An excess of morbidityand mortality (non-COVID) would be possible during or after the epidemic in connectionwith this "under-medicalization" of non-COVID patients.The aim of this study is to measure and analyze the impact on the morbidity and mortalityof inpatients during and after the COVID-19 epidemic in the adult inpatient wards of HUGand township hospitals / clinics.

Institut de Recherches Cliniques de Montreal

Study of Isoquercetin (IQC-950AN) Plus Standard of Care Versus Standard of Care Only for the Treatment of COVID-19

Conditions: COVID-19

This is an open-label, randomized, multi-centre study where hospitalized subjects will berandomized in a 2:1 ratio to receive Isoquercetin (IQC-950AN) in addition to standard ofcare or standard of care only for 28 days following confirmation of a COVID-19 infection.

Medical University Innsbruck

Neurological Outcome After SARS-CoV-2 Infection

Conditions: SARS-CoV-2, Post-acute COVID-19 Syndrome

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

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Status

  • Unknown status (254)
  • Recruiting (129)
  • Active, not recruiting (116)
  • Enrolling by invitation (14)
  • Not yet recruiting (11)
  • Approved for marketing (3)
  • Available (3)

Intervention Type

  • Other (159)
  • Drug (134)
  • Biological (75)
  • Diagnostic Test (51)
  • Behavioral (24)
  • Device (16)
  • Procedure (11)
  • Dietary Supplement (8)
  • Radiation (7)
  • Combination Product (5)
  • Genetic (1)

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© Reagan-Udall Foundation for the FDA