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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 75 of 75

International Vaccine Institute

Efficacy, Immunogenicity and Safety of BBIBP-CorV Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection.

Conditions: COVID-19 Disease

To expand the access and delivery of COVID-19 Vaccines in Africa (ECOVA), theinvestigators will conduct a phase 3, individually randomized, observer-blind, controlled(influenza vaccine) trial to evaluate the safety and efficacy of the BBIBP-CorV vaccineagainst any severe acute respiratory syndrome 2 (SARS-CoV- 2) infection among adults 18years and older. The BBIBP-CorV vaccine is an inactivated SARS-CoV-2 vaccine (Vero cell)manufactured by the Beijing Institute of Biological Products (BIBP), China NationalBiotec Group (CNBG), Sinopharm, Beijing, People's Republic of China and receivedemergency use authorization (EUA) from World Health Organization (WHO).

Walvax Biotechnology Co., Ltd.

Phase I Clinical Trial of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19

Conditions: COVID-19

The purpose of this double-blind, randomized, controlled study is to assess safety,reactogenicity, and preliminary immunogenicity of 202-CoV at multiple dose levels,administered as 2 injections (i.m) at 28 days apart in adult subjects 18 years of age andabove.

GeoVax, Inc.

SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer

Conditions: Covid-19 Infection, Hematopoietic and Lymphoid System Neoplasm, Leukemia, Lymphoma, Plasma Cell Myeloma

This phase 2 trial studies the immune response to GEO-CM04S1 (previously designated asCOH04S1) compared to standard of care (SOC) mRNA SARS-COV-2 vaccine in patients withblood cancer who have received stem cell transplant or cellular therapy.GEO-CM04S1 belongs to a category called modified vaccinia Ankara (MVA) vaccines, createdfrom a new version of MVA, called synthetic MVA. GEO-CM04S1 works by inducing immunity(the ability to recognize and fight against an infection) to SARS-CoV-2. The immunesystem is stimulated to produce antibodies against SARS-CoV-2 that would block the virusfrom entering healthy cells. The immune system also grows new disease fighting T cellsthat can recognize and destroy infected cells. Giving GEO-CM04S1 after cellular therapymay work better in reducing the chances of contracting coronavirus disease 2019(COVID-19) or developing a severe form of COVID-19 disease in patients with blood cancercompared to SOC mRNA SARS-CoV-2 vaccine.

Shenzhen Geno-Immune Medical Institute

Immunity and Safety of Covid-19 Synthetic Minigene Vaccine

Conditions: Pathogen Infection Covid-19 Infection

In December 2019, viral pneumonia caused by a novel beta-coronavirus (Covid-19) broke outin Wuhan, China. Some patients rapidly progressed and suffered severe acute respiratoryfailure and died, making it imperative to develop a safe and effective vaccine to treatand prevent severe Covid-19 pneumonia. Based on detailed analysis of the viral genome andsearch for potential immunogenic targets, a synthetic minigene has been engineered basedon conserved domains of the viral structural proteins and a polyprotein protease. Theinfection of Covid-19 is mediated through binding of the Spike protein to the ACEIIreceptor, and the viral replication depends on molecular mechanisms of all of these viralproteins. This trial proposes to develop and test innovative Covid-19 minigenesengineered based on multiple viral genes, using an efficient lentiviral vector system(NHP/TYF) to express viral proteins and immune modulatory genes to modify dendritic cells(DCs) and to activate T cells. In this study, the safety and efficacy of this LV vaccine(LV-SMENP) will be investigated.

Shenzhen Geno-Immune Medical Institute

Safety and Immunity of Covid-19 aAPC Vaccine

Conditions: Treat and Prevent Covid-19 Infection

In December 2019, viral pneumonia (Covid-19) caused by a novel beta-coronavirus(SARS-CoV-2) broke out in Wuhan, China. Some patients rapidly progressed and sufferedsevere acute respiratory failure and died, making it imperative to develop a safe andeffective vaccine to treat and prevent severe Covid-19 pneumonia. Based on detailedanalysis of the viral genome and search for potential immunogenic targets, a syntheticminigene has been engineered based on conserved domains of the viral structural proteinsand a polyprotein protease. The infection of Covid-19 is mediated through binding of theSpike protein to the ACEII receptor, and the viral replication depends on molecularmechanisms of all of these viral proteins. This trial proposes to develop universalvaccine and test innovative Covid-19 minigenes engineered based on multiple viral genes,using an efficient lentiviral vector system (NHP/TYF) to express viral proteins andimmune modulatory genes to modify artificial antigen presenting cells (aAPC) and toactivate T cells. In this study, the safety and immune reactivity of this aAPC vaccinewill be investigated.

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Status

  • Unknown status (35)
  • Active, not recruiting (17)
  • Recruiting (14)
  • Not yet recruiting (6)
  • Approved for marketing (1)
  • Available (1)
  • Enrolling by invitation (1)

Intervention Type

  • (-) Biological (75)
  • Other (15)
  • Drug (11)
  • Behavioral (2)
  • Combination Product (1)
  • Device (1)
  • Diagnostic Test (1)

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