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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. Animal Health & Veterinary Medicine
          1. Antimicrobial Use in Food Animals
          2. Industry SWOT Analysis
        2. Expanded Access
          1. E-request App
          2. Navigator
          3. Resources for COVID-19
        3. FDA Patient Listening Sessions
        4. 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. Column 2
        1. Improving Access to FDA Information
          1. Understanding FDA & FDA-Regulated Products
          2. Improving Access to Publicly Available FDA Information
        2. Research
          1. About
          2. Cross-Sectoral Health Threats
          3. IMEDS
          4. Post Market Research
          5. RAISE
          6. Real World Data
          7. Regulatory Science Accelerator
        3. Substance Use Disorders
  • News and Events
      1. Innovations in Regulatory Science & Policy Awards
      2. 2024 Annual Public Meeting
      3. Events
      4. News
      5. Publications
  • 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 4 of 4

Weill Medical College of Cornell University

Accelerated TMS for Depression and OCD

Conditions: Depression, OCD

Repetitive transcranial magnetic stimulation (rTMS) is a FDA-approved treatment fordepression and Obsessive Compulsive Disorder (OCD). The goal of the study is to learn howto optimize the treatment to improve symptoms of depression and OCD. This researchproject will test a new accelerated 5-day accelerated rTMS protocol for treating symptomsof depression and OCD.A second goal of this study is to identify biomarkers of depression and OCD in the brainusing functional magnetic resonance imaging (fMRI). This approach will predict who willbenefit from TMS, determine the optimal treatment target, and improve treatment outcomes.Subjects will receive a clinical assessment of symptoms and an fMRI brain scan before andafter each treatment course to measure the effect of treatment on symptom severity and onfMRI measures of functional connectivity.Participants will be randomized to receive rTMS targeting either the lateral prefrontalcortex (LPFC) or the dorsomedial prefrontal cortex (DMPFC). Participants will complete a5-day course of rTMS delivered hourly for 10 hours per day. Participants who show apartial response to treatment but not a full response will then receive a second 5-daycourse. Treatment non-responders will be crossed over to receive rTMS targeting theopposite brain area.The primary hypothesis is that accelerated rTMS treatment will yield rapid improvement insymptoms for patients with depression and OCD in just 5 days, and that response rates canbe further improved by adding a second 5-day treatment course.

Nanowear Inc.

The Nanowear Wearable Covid-19 Observational and Analysis Trend

Conditions: COVID19

The NanoCOAT study is a multi-center, prospective, non-randomized, feasibility,observational, non-significant risk study. The NanoCOAT study will enroll a minimum of 10and a maximum of 100 subjects in a potential for a multi-site in order to collect dataand analyze physiological and biometric trends due to Covid-19.

Instituto Nacional de Perinatologia

Local Thermotherapy for Patients With Mild-to-moderate COVID-19

Conditions: COVID-19, Thermotherapy

The etiological agent of the current pandemic is a (+)ssRNA virus. SARS-CoV-2 isinfecting thousands of people in the world with a fatality rate that varies from 0.1 to5% in affected countries, thereby causing enormous economic losses. Few antibiotics haveshown any efficacy in their combat, but have not yet proven adequate to stop the spreadof the disease, nor are there any approved vaccines at the moment. From experiments inplants ongoing infections by RNA viruses, using thermotherapy, which is the applicationof heat at a temperature between 35-43 °C, the investigators know that raising thetemperature affects the transcription of viral proteins due to the formation of small RNAmolecules that interrupt the replication process by grouping in specific regions of theRNA molecule, preventing and inhibiting transcription. These small molecules are calledsmall interfering RNAs (siRNAs). This feature has been used through thermotherapy inhumans to combat the rapid replication of cells (i.e. cancer cells), attack cellsinfected by RNA viruses, and in the treatment of some parasitic infections.There arevarious commercially available devices for thermotherapy use in humans; they are mainlybeing used to ease muscle pain. They work by increasing the temperature in the rangerecommended for thermotherapy in humans 39-43 ° C. Therefore, the investigators considerthis treatment modality can be used to aid in the elimination of SARS-CoV-2 from thehuman body, decreasing viral load, which could allow the immune system time for itscontrol and elimination.

University of Giessen

Low-flow Extracorporeal Carbon Dioxide Removal in COVID-19-associated Acute Respiratory Distress Syndrome

Conditions: ARDS, Hypercapnic Respiratory Failure, AKI

The study aims to investigate the efficacy of extracorporeal CO2 removal for correctionof hypercapnia in coronavirus disease 19 (COVID-19)-associated acute respiratory distresssyndrome

Status

  • (-) Recruiting (4)

Intervention Type

  • (-) Device (4)

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© Reagan-Udall Foundation for the FDA