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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. Cross-Sectoral Health Threats
          3. 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. 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. 2025 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 134 of 134

Massachusetts General Hospital

NO Prevention of COVID-19 for Healthcare Providers

Conditions: Coronavirus Infections, Healthcare Associated Infection

Thousands of healthcare workers have been infected with SARS-CoV-2 and contractedCOVID-19 despite their best efforts to prevent contamination. No proven vaccine isavailable to protect healthcare workers against SARS-CoV-2.This study will enroll 470 healthcare professionals dedicated to care for patients withproven SARS-CoV-2 infection. Subjects will be randomized either in the observational(control) group or in the inhaled nitric oxide group. All personnel will observe measureson strict precaution in accordance with WHO and the CDC regulations.

National Cancer Institute, Naples

Tocilizumab in COVID-19 Pneumonia (TOCIVID-19)

Conditions: COVID-19 Pneumonia

This study project includes a single-arm phase 2 study and a parallel cohort study,enrolling patients with COVID-19 pneumonia.

University Hospital, Akershus

Norwegian Coronavirus Disease 2019 Study

Conditions: Corona Virus Infection

In the current proposal, the investigators aim to investigate the virological andclinical effects of chloroquine treatment in patients with established COVID-19 in needof hospital admission. Patients will be randomized in a 1:1 fashion to standard of careor standard of care with the addition of therapy with chloroquine.

Unity Health Toronto

COVID-19 Ring-based Prevention Trial With Lopinavir/Ritonavir

Conditions: Coronavirus Infections, Post-exposure Prophylaxis

COVID-19 has rapidly evolved into a generalized global pandemic. Post-exposureprophylaxis (PEP) against on COVID-19 was identified as an urgent research priority bythe WHO, and lopinavir/ritonavir (LPV/r) is a promising candidate for both COVID-19treatment and PEP, with a good safety profile and global availability. This is a clusterrandomized controlled trial (RCT) of oral LPV/r as PEP against COVID-19, that willaddress the immediate need for preventive interventions, generate key data on COVID-19transmission, and serve as a research platform for future vaccines and preventive agents.

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Status

  • Unknown status (64)
  • Active, not recruiting (37)
  • Recruiting (19)
  • Enrolling by invitation (5)
  • Not yet recruiting (4)
  • Available (3)
  • Approved for marketing (2)

Intervention Type

  • (-) Drug (134)
  • Other (17)
  • Biological (11)
  • Dietary Supplement (4)
  • Combination Product (3)
  • Device (1)
  • Procedure (1)
  • Radiation (1)

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© Reagan-Udall Foundation for the FDA
© Reagan-Udall Foundation for the FDA