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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 200 of 254

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

Centre Hospitalier de Cayenne

Comparison of Detection of SARS-CoV2 (COVID-19) Between Nasopharyngeal Swab Specimens and Those Obtained by Salivary Sputum

Conditions: COVID19

Multicenter observational study of diagnostic test validation (Research Involving theHuman Person, type 3) In addition to the diagnosis by the reference method(nasopharyngeal swab), the patient will be asked to provide a saliva sample via asalivary spit. The clinical circumstances of the diagnosis, the age of the patient, theassociated terrain (diabetes, immunodepression, pregnancy) will be noted. Thenasopharyngeal and saliva samples will be analyzed in Cayenne and the remaining sampleswill be frozen and stored at the CRB before being sent to the University Hospital of Caenfor analysis and concordance verification.The expected benefits are:Possibility of repeating tests in the same person more easily due to the absence of painand thus reduce the barriers to diagnosis and screening.Possibility of self-sampling, which could simply be sent to the laboratory, which wouldrelieve the diagnostic sites that mobilize staff and require a fairly heavy organization.Avoid long waiting lines that can be an obstacle and lead to a renunciation of thediagnosis.

Centre Hospitalier Universitaire de Nīmes

Retrospective Study of COVID-19 Vaccines in Patients Undergoing Immunotherapy for Cancer.

Conditions: Cancer, Immunotherapy

The investigators wish to set up a pharmaco-epidemiological cohort within the HospitalTerritorial Groups of the Cévennes-Gard Camargue, East-Hérault and Haute-Garonne and WestTarn on a specific population, patients undergoing immunotherapy for cancer, as currentlythere is no data available under "real life" conditions following anti-COVIDvaccination19. The hypothesis is that patients undergoing immunotherapy will not developmore vaccine-related adverse events than those observed in the efficacy and safetyvalidation studies of the BNT162b2 mRNA Covid-19, mRNA-1273 SARS CoV-2,Oxford/AstraZeneca and Ad26COV2.S, JMJ Vaccine or J & J COVID-19 Vaccine.

Beijing 302 Hospital

A Trial of Novaferon in Asymptomatic or Mild COVID-19 Patients

Conditions: SARS-CoV2 Infection

This is a phase III randomized, double blinded, placebo-controlled multi-center study toassess the efficacy and safety of aerosolized Novaferon for the treatment of asymptomaticor mildly patients infected with SARS-CoV-2.

Michal Chudzik

Early and Late Complications of COVID-19

Conditions: COVID19, LONG-COVID

Coronavirus disease 2019 (COVID-19) is a serious respiratory disease that results frominfection with a newly discovered coronavirus (SARS-COV-2). Unfortunately, COVID-19 isnot only a short-term infection. Patients (pts) recovering from SARS-COV2 infectioncomplain of persisting symptoms including: fatigue, diffuse myalgia and weakness, whichmay lead to chronic fatigue syndrome and as well as many other complications.The vast majority of COVID-19 patients remaining in isolation/quarantine, due to the mildcourse of the disease, do not require hospitalization. In this group of patients, thecourse of COVID-19 is very different - from asymptomatic patients to very severe and longlasting symptoms also with a decrease in saturation.There are many studies describing the course and complications of patients hospitalizeddue to COVID-19. There is little published data on how non-hospitalized patients get sickand what are the early and late complications of SARS-CoV-2 infection. In addition, manypatients remain ill even many months after COVID-19, entering what is known asLONG-COVID.Therefore, the STOP-COVID Registry was established. The purpose of the Registry is toassess the course of COVID-19 infection, early and late cardiovascular complications ofCOVID-19 in patients with and without hospitalization. In addition, the purpose of theSTOP-COVID Registry is to assess the incidence of LONG-COVID with all other complicationsand to identify predictive factors.

Ministry of Health, Thailand

Andrographis Paniculata vs Boesenbergia Rotunda vs Control in Asymptomatic COVID-19

Conditions: COVID19

The purpose of this study is to examine the effect of Andrographis Extract, BoesenbergiaExtract compared to standard treatment in asymptomatic COVID patients.

Azienda Sanitaria-Universitaria Integrata di Udine

Diaphragm Ultrasound Evaluation During Weaning From Mechanical Ventilation in the Positive COVID-19 Patient

Conditions: COVID-19 Pneumonia, Diaphragm Disease

Hypoxemic acute respiratory failure is one of the main COVID-19 patients complicationthat lead to in intensive care hospitalization.This complication determines a variable mortality from 25 to 30%. To correct hypoxemia(often severe) is often needed non-invasive or invasive mechanical ventilation.Mechanical ventilation is not a therapeutic strategy, but it allows to extend thetime-to-recovery necessary to solve COVID-19 respiratory failure cause.Calibration of ventilatory support is essential to ensure adequate time-to-recoverywithout contributing to onset lung and / or diaphragmatic damage.Basal diaphragmatic activity assessment, device for administering the oxygenation supportchoice and setting ventilatory support parameters are decisive.Ultrasound is the best method for measuring diaphragmatic work. The aim of this study isto evaluate the diaphragmatic thickening fraction in COVID-19 patients admitted toIntensive Care Unit (ICU) for acute respiratory failure and to record its function onweaning.

National Institute of Allergy and Infectious Diseases (NIAID)

Long-term Neurocognitive and Psychiatric Consequences in Severe COVID-19 Survivors.

Conditions: COVID19, Neurocognitive Dysfunction

Long-term neurocognitive and psychiatric consequences of COVID-19 remain mostly unknownto date. It has been reported that coronaviruses cause direct central nervous systeminfection (Needham et al. 2020). Besides that, new or worsening cognitive impairmentcommonly occurs and persists in survivors of intensive care unit (ICU) stay (Hosey &Needham. 2020). The purpose of our study is to search and describe the cognitive andpsychiatric long-term consequences of COVID-19 on patients who have been discharged fromcritical care units. This is an ambidirectional cohort study, that attempts to followadults discharged from critical Care Units Adults due to COVID-19 up to 12 months afterdischarge, to evaluate the presence of cognitive impairment, linguistic and phonationfunction, depression, fatigue, functional gastroenterological symptoms, anxiety, or posttraumatic disorder, and performance in activities of daily living and physical responseto exercise as well.

Ohio University

Acceptability/Feasibility of COVID-19 Intervention

Conditions: Social Isolation, Emotional Disorder

The coronavirus (COVID-19) pandemic is a significant psychological stressor thatthreatens the onset of a mental health crisis in the US. Fear and anxiety about COVID-19and its economic impact, as well as loneliness due to the required social isolation, aredriving the mental health impacts of COVID-19; in a recent Kaiser Family Foundation poll,45% of respondents reported that the coronavirus has had a negative impact on theirmental health. This is reflected in Southeastern Ohio. In data that the investigatorscollected from 317 Ohio University faculty, staff, and students from late May to earlyJune, 39% reported moderate-to-severe levels of anxiety, 41% reported moderate-to-severelevels of depression and 57% reported the COVID-19 outbreak was impacting their sense ofsocial connection much or very much. Despite the significant community need foraccessible and affordable care, there are currently no evidence-based interventions forindividuals coping poorly with coronavirus-related distress. The investigators havedeveloped a virtual group-based intervention targeting cognitive biases that amplify theexperience of stress and anxiety (i.e., amplifying cognitions; Coping withCoronavirus-Related Emotion and Worry [COPING CREW]). The next step in developing thisintervention in a scientifically rigorous manner is to refine the manual and proceduresand conduct a pilot test of the intervention.

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Status

  • (-) Unknown status (254)

Intervention Type

  • Other (76)
  • Drug (64)
  • Biological (35)
  • Diagnostic Test (29)
  • Behavioral (10)
  • Device (8)
  • Procedure (6)
  • Combination Product (5)
  • Dietary Supplement (4)
  • Radiation (3)

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© Reagan-Udall Foundation for the FDA