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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 70 of 75

Imperial College London

A Study to Determine Safety and Immunogenicity of the Candidate COVID-19 Vaccine AZD1222 Delivered by Aerosol in Healthy Adult Volunteers

Conditions: COVID19, SARS-CoV-2 Infection

This study will test the COVID-19 vaccine candidate AZD1222 to investigate its safety,tolerability and capability of boosting immune responses both in the blood and the lungwhen administered to the respiratory tract, in volunteers previously vaccinated byintramuscular COVID-19 vaccination. Using standardised methods, we will measure immuneresponses in the blood, nose and lower airway and compare with data from ongoing clinicaltrials of intramuscular vaccination. Thus, we will show the effect of the delivery methodand provide the critical information required to begin further clinical trials to showthe efficacy of this needle-free vaccination strategy for booster vaccination.

The Second Affiliated Hospital of Chongqing Medical University

Safety and Immune Response of COVID-19 Vaccination in Patients With Chronic Liver Diseases

Conditions: Liver Diseases, COVID19, Adverse Reaction to Vaccine

On 11 February 2020, the International Committee for the Classification of Viruses namedthe disease caused by SARS-CoV-2 infection in humans as the new coronavirus pneumonia(coronavirus disease 2019, COVID-19). Due to the characteristics of livermicrocirculation disturbance and immune function disorder in patients with chronic liverdiseases (such as immune liver disease, chronic hepatitis C, liver cirrhosis, livercancer, etc.), those patients has a higher risk of infection than the general populationduring the epidemic period. More attention should be paid to personal protection anddisease prevention. Vaccination of COVID-19 vaccine can effectively prevent COVID-19virus infection and delay or prevent patients from developing into critical illness andreduce mortality. To evaluate the safety and effectiveness of COVID-19 vaccine in thosepatients with chronic liver diseases, and to guide the COVID-19 vaccination morescientifically, reasonably and effectively, this study was carried out.

Fundación Huésped

Phase IIb Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV) in Adults 18 Years of Age and Older.

Conditions: COVID19

A randomized, double-blind, placebo -controlled, phase IIb clinical trial to evaluate theefficacy, safety and immunogenicity of one or two doses of Recombinant Novel CoronavirusVaccine (Adenovirus Type 5 Vector) in adults 18 years of age and older, living with HIV,on stable treatment, and virologically suppressed for at least 6 monthsProtocol number: FH-58

Shenzhen Kangtai Biological Products Co., LTD

Clinical Trial of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Population Aged 3 to 17 Years(COVID-19)

Conditions: COVID-19

This study is a randomized, double-blinded, and placebo controlled phase Ⅰ clinical trialof the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of theexperimental vaccine in healthy population aged 3 to 17 years.

Shenzhen Kangtai Biological Products Co., LTD

Study of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 3 to 17 Years(COVID-19)

Conditions: COVID-19

This study is a randomized, double-blinded, and placebo controlled phase Ⅱ clinical trialof the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of theexperimental vaccine in healthy population aged 3 to 17 years.

International AIDS Vaccine Initiative

A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core)

Conditions: HIV

A Phase 1, Randomized, First-in-human, Open-label Study to Evaluate the Safety andImmunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNAVaccine (mRNA-1644v2-Core) in HIV-1 Uninfected Adults in Good General Health

International Vaccine Institute

Mix and Match Heterologous Prime-Boost Study Using Approved COVID-19 Vaccines

Conditions: COVID19

This is an observer-blind, randomized study which aims to assess the immune response andthe safety of two different approved vaccines for first and second dose in healthyadults.

Universidad del Desarrollo

Reactogenicity, Safety, and Immunogenicity of Covid-19 Vaccine Booster

Conditions: COVID19

Preliminary data suggest that inactivated vaccine-induced neutralizing antibodies againstSARS-CoV-2 decrease at six months after vaccination. Observational, unpublished data alsoindicate that vaccine effectiveness against Covid-19 wanes over time. Thus, theinvestigators aimed to determine the reactogenicity, safety, and immunogenicity of ahomologous or heterologous booster of SARS-CoV-2 vaccines among people already immunizedwith an inactivated SARS-CoV-2 vaccine. The study focuses on the elderly population andhealthcare workers.

Walvax Biotechnology Co., Ltd.

Phase II 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 assessimmunogenicity and safety of 202-CoV at multiple dose levels, administered as 2injections (i.m) at 28 days apart in adult subjects 18 years of age and above.

Russian Direct Investment Fund

Collaborative Study to Evaluate Heterologous Vaccination Against Covid-19 in Argentina

Conditions: COVID-19 Vaccine, COVID19

Randomized, open, multicenter, collaborative and adaptive non-inferiority trial toevaluate the immunogenicity and reactogenicity of the heterologous vaccination schedulesmade up of the combination of vaccines available in Argentina (Sputnik-V, AstraZeneca,Sinopharm and Moderna); and to compare the immunogenicity and reactogenicity ofheterologous and homologous vaccination schedules.

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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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