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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 134 of 134

Sanofi

Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma

Conditions: Plasma Cell Myeloma

Primary Objectives: - Safety run-in Part: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) - Randomized Phase 3 Part: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMMSecondary Objectives:Safety run-in Part: - To assess overall response rate (ORR) - To assess duration of response (DOR) - To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR) - To assess time to diagnostic (SLiM CRAB) progression or death - To assess time to first-line treatment for multiple myeloma (MM) - To assess the potential immunogenicity of isatuximab - Impact of abnormal chromosomal subtype on participant outcomeRandomized Phase 3 Part:Key Secondary Objectives:To compare between the arms - MRD negativity - Sustained MRD negativity - Second progression-free survival (PFS2) - Overall survivalOther Secondary Objectives:To evaluate in both arms - CR rate - ORR - DOR - Time to diagnostic (SLiM CRAB) progression - Time to biochemical progression - Time to first-line treatment for MM - Impact of abnormal chromosomal subtype on participant outcome - Safety and tolerability - Pharmacokinetics (PK) - Potential of isatuximab immunogenicity - Clinical outcome assessments (COAs)

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.

University of Alabama at Birmingham

Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19

Conditions: Coronavirus Infections, Pneumonia, Viral, Acute Respiratory Distress Syndrome

The scientific community is in search for novel therapies that can help to face theongoing epidemics of novel Coronavirus (SARS-Cov-2) originated in China in December 2019.At present, there are no proven interventions to prevent progression of the disease. Somepreliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could havebeneficial effects on SARS-CoV-2 due to the genomic similarities between this twocoronaviruses. In this study we will test whether inhaled NO therapy prevents progressionin patients with mild to moderate COVID-19 disease.

Qilu Hospital of Shandong University

Bevacizumab in Patients With Severe Covid-19

Conditions: COVID-19 Pneumonia

The novel coronavirus (SARS-CoV-2) is a new strain of coronavirus found in human in 2019,which causes epidemic worldwide. Novel coronavirus disease (COVID-19) causes acute lunginjury (ALI) and acute respiratory distress syndrome (ARDS) in patients with severeCOVID-19. Pulmonary edema is the key detrimental feature of ALI/ARDS. Autopsy of patientsdied from COVID-19 reported that, pulmonary mucus exudation was more severe and obviousthan SARS infection. Pulmonary CT scanning and pathological findings also suggest thatpulmonary edema caused by inflammatory exudation is a distinguished feature of COVID-19.Vascular endothelial growth factor (VEGF), also known as vascular permeability factor(VPF), is known as the most potent factor to increase vascular permeability, with theinduction effect 50,000 times stronger than histamine. Bevacizumab is an anti-VEGFrecombinant humanized monoclonal antibody, which has been used in anti-tumor treatmentsince 2004, with considerable reliability and clinical safety. This trial will providehigh level evidence to answer whether bevacizumab is efficacy and safe medication forpatients with severe COVID-19.

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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