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Home
  • About
      1. Board of Directors
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      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 40 of 75

E-MO Biology Inc

Polio Vaccine (IPV) for SARS-CoV-2 and Prevention of Coronavirus Disease (COVID-19)

Conditions: SARS-CoV-2

A total of 300 healthy volunteers between the ages of 18 and 80 with no previous historyof COVID-19 will be entered into the study and will receive IPV by injection on Day 1.Blood specimens collected pre-inoculation will be tested for cross-reactivity topoliovirus and SARS-CoV-2 by Western blot. An additional specimen will be collected onDay 28 post-inoculation and, likewise tested for cross-reactivity to poliovirus andSARS-CoV-2.The number of subjects with an immune response to SARS-CoV-2 antigens followinginoculation with IPV will be summarized.

GeoVax, Inc.

A Synthetic MVA-based SARS-CoV-2 Vaccine, GEO-CM04S1, for the Prevention of COVID-19 Infection

Conditions: Covid-19 Infection

This phase I trial evaluates the side effects and best dose of GEO-CM04S1 (previouslydesignated as COH04S1), a synthetic modified vaccinia Ankara (MVA)-based SARS-CoV-2vaccine, for the prevention of COVID-19 infection. COVID-19 infection is caused by theSARS-CoV-2 virus. SARS-CoV-2 has demonstrated the capability to spread rapidly, leadingto significant impacts on healthcare systems and causing societal disruption. GEO-CM04S1was created by placing small pieces of SARS-CoV-2 DNA (the chemical form of genes) intosynthetic MVA, which may be able to induce immunity (the ability to recognize and fightagainst an infection) to SARS-CoV-2. The purpose of the Phase 1 study is to determine thesafety and the optimal dose of the GEO-CM04S1 vaccine.The Phase 2 study is designed as a multi-center, double-blind, randomized, parallel,study to evaluate the safety profile of 2 dose levels of GEO-CM04S1 as a single boostershot to assess the immune response measured by the fold-increase in antibody againstSARS-CoV-2 Spike protein at day 28 post-injection among healthy adult volunteers.

Medicago

Study of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults

Conditions: SARS-CoV-2 Infection

This Phase 2/3 study is a multi-portion design to confirm that the chosen formulation anddosing regimen of CoVLP has an acceptable immunogenicity and safety profile.The Phase 3 portion is an event-driven, randomized, observer blinded, placebo-controlleddesign that will evaluate the efficacy and safety of the CoVLP formulation compared toplacebo.Subjects will be followed for safety and immunogenicity for a period of 12 months afterthe last vaccination.

Jiangsu Province Centers for Disease Control and Prevention

Phase I Trial of a Recombinant COVID-19 Vaccine (CHO Cell)

Conditions: COVID-19

This is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safetyand immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthypopulation aged 18 years and older. After randomization, the trial for each subject willlast for approximately 13 months. Screening period is 1 week prior to randomization (Day-7 to Day -1), and each dose of either SARS-CoV-2 vaccine (CHO Cell) or placebo will begiven intramuscularly (IM) on Day 0 and Day 14 for a two-dose regimen, or on Day 0, Day14, and Day 28 for a three-dose regimen. Subjects who are ≥18 years old and ≤ 59 yearsold will be enrolled in adult group, and healthy elderly population who are >59 years oldwill be enrolled in elderly group. After adult group completes the follow-up 7 days afterfirst vaccination, elderly group will be recruited.

Longeveron Inc.

Regenerative Medicine for COVID-19 and Flu-Elicited ARDS Using Lomecel-B (RECOVER)

Conditions: ARDS, Human, COVID19

A Phase I, double- blinded, randomized, placebo- controlled study to test the safety ofLomecel-B in Adults suffering from mild to severe acute respiratory distress syndrome(ARDS) due to COVID-19 resultant from 2019-nCoV coronavirus infection, or resultant frominfluenza virus infection.

Cristina Avendaño Solá

Clinical Trial to Assess the Efficacy of MSC in Patients With ARDS Due to COVID-19

Conditions: Acute Respiratory Distress Syndrome, COVID-19 Pneumonia

A double-blind, randomized, controlled, clinical trial to evaluate the efficacy andsafety of MSC (mesenchymal stromal cells) intravenous administration in patients withCOVID-induced ARDS compared to a control arm.

Chinese University of Hong Kong

Lung Function, Exercise Capacity, and Serology Responses in Patients With COVID-19

Conditions: Lung Function, Exercise Capacity, Quality of Life, COVID19

(a) Objectives 1. To assess the full lung function, exercise capacity, quality of life in patients with COVID-19 over 2 years. 2. To assess the longevity of the serology response to SARS-CoV2. 3. To investigate the association of the neutralization titer in plasma from different vaccinated cohorts to its protection of infection using in vivo model 4. To investigate the SARS-CoV-2 specific cellular and humoral immunities as well as their determinant factors from community subjects who have received different types of COVID-19 vaccines. 5. To assess the third booster dose for subjects who have poor antibody response despite having received two doses of CoronaVac (Sinovac)

SK Bioscience Co., Ltd.

Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With or Without AS03 (COVID-19)

Conditions: COVID-19 (Healthy Volunteers)

This is a first-in-human, Phase I/II, randomized, placebo-controlled, observer-blinded,age-escalating study to assess the safety, reactogenicity and immunogenicity of a SKSARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with or withoutAS03 in healthy younger and older adults.

University of Campania Luigi Vanvitelli

Cellular-Mediated Immunity in COVID-19

Conditions: COVID19, Thromboembolism

In order to prevent reinfection, it is needed to detect the cellular-mediated immuneresponse to the Sars-CoV-2 infection. The first goal of this study will be to detect thecellular-mediated immune response in patients affected by COVID-19 (with or withoutvaccination) and healthy subjects who undergone vaccination program. The second goal ofthis study will be to identify the genetic and epigenetic biomarkers that influenceindividual immunological response and clinical evolution to the severe manifestations ofthe COVID-19.

National and Kapodistrian University of Athens

Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System

Conditions: COVID-19, Healthy Volunteers, Chronic Disease, Hematological Malignancies, Solid Tumor

Determination of both the degree and duration of the immunity provided after receivingthe BNT162b2 vaccine against SARS-Cov-2.

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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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