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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 100 of 134

ZEO ScientifiX, Inc.

Expanded Access to Zofin for Patients With COVID-19

Conditions: COVID19, Corona Virus Infection, SARS (Severe Acute Respiratory Syndrome), Acute Respiratory Distress Syndrome

This expanded access protocol will provide access to the investigational product Zofinfor patients in outpatient facilities infected with SARS-CoV-2 who have mild to moderateCOVID-19, or who are judged by a healthcare provider to be at high risk of progression tomoderate disease.

Qurient Co., Ltd.

Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor in Patients with Advanced Solid Tumor

Conditions: Solid Tumor, Advanced Cancer, Metastatic Cancer

This is a Phase 1, open-label, multicenter, dose-escalation, safety, tolerability,pharmacokinetic and pharmacodynamic study with cohort expansion at the RP2D to evaluatesafety and anti- tumor activity of Q702 administered orally.

MedRegen LLC

MRG-001 as an Immunoregulatory and Regenerative Therapy for COVID-19 Patients

Conditions: COVID-19, ARDS, Human, Stem Cells, Regeneration

This study consists of two parts.Part A (Phase I):A Phase I Double-blind Randomized Placebo-controlled Study in Healthy Subjects to Assessthe Safety, Pharmacokinetics, Pharmacodynamics of MRG-001Part B (Phase 2):A Phase IIa, Adaptive, Double-Blind, Randomized, Placebo-controlled, Multi-center Studyin Hospitalized Patients Infected with Severe and Critical SARS-CoV-2 to Assess theSafety, Pharmacokinetics, Pharmacodynamics and Efficacy of MRG-001

Sanofi

Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

Conditions: Plasma Cell Myeloma Refractory

The purpose of this umbrella study is to evaluate isatuximab when combined with novelagents with or without dexamethasone in participants with relapsed or refractory myeloma.Substudy 01 is the control Substudy. Substudies 02, 03, and 06 are controlledexperimental substudies. Substudies 04 and 05 are independent experimental substudies.

Op-T LLC

1a/1b Study of OPT101 First in Human Study Assessing Safety and Tolerability of 15-mer Peptide.

Conditions: Healthy

This is a first-in-human study, Phase 1, randomized, placebo-controlled, double blindedstudy that will be conducted in 2 parts.

GeneOne Life Science, Inc.

GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19)

Conditions: Pneumonitis, SARS-CoV Infection

This clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 inthe prevention of severe pneumonitis caused by SARS-CoV-2 infection

Ottawa Heart Institute Research Corporation

The COVID-RASi Trial (COVID-19)

Conditions: COVID-19, Cardiovascular Diseases

The COVID-RASi study is an international randomized clinical trial that will evaluate thepotential benefit of angiotensin modulators on clinical outcomes, in COVID-19 patients.The purpose of this study is to determine if renin-angiotensin system inhibitors (RASi),with angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers(ARB), has a beneficial effect in patients with COVID-19 infections, by reducing ICUadmission, ventilator requirement or death. We would also like to determine if there aredifferences between ACEi and ARB therapeutic treatments. With the increasing potential oflong COVID symptoms, at the 1 year follow up, a primary endpoint will be the quality oflife of study participants, as assessed by ongoing symptoms and/or the standardizedquestionnaires.

National Institute on Aging (NIA)

A Phase 2 Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Older Adults

Conditions: COVID19

The proposed trial will obtain preliminary data on the feasibility of studying RTB101 ascompared to placebo for COVID-19 post-exposure prophylaxis in adults age ≥ 65 years toinform the design of a subsequent pivotal trial.

Imperial College London

Inflammatory Signal Inhibitors for COVID-19 (MATIS)

Conditions: Coronavirus, COVID19, Pneumonia

The Multi-arm trial of Inflammatory Signal Inhibitors for COVID-19 (MATIS) study is atwo-stage, open-label, randomised controlled trial assessing the efficacy of ruxolitinib(RUX) and fostamatinib (FOS) individually, compared to standard of care in the treatmentof COVID-19 pneumonia. The primary outcome is the proportion of hospitalised patientsprogressing from mild or moderate to severe COVID-19 pneumonia. Patients are treated for14 days and will receive follow-up assessment at 7, 14 and 28 days after the first studydose. Patients with mild or moderate COVID-19 pneumonia will be recruited. Initially,n=171 (57 per arm) patients will be recruited in Stage 1. Following interim analysis toassess the efficacy and safety of the treatments, approximately n=285 (95 per arm) willbe recruited during Stage 2.

Soroka University Medical Center

Pegylated Interferon Lambda for Treatment of COVID-19 Infection

Conditions: COVID-19

A randomized, open-label, 2 arm, pilot trial of Lambda 180 mcg administeredsubcutaneously once weekly, for up to two weeks (2 injections at most), in addition tostandard supportive care, compared to standard supportive care alone, in a population ofCOVID-19 infected patients.patients will be randomized according to 1:1 ratio to one of the 2 trial arms: Lambda 180mcg S.C + standard care (intervention arm) or standard care only (control arm).

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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