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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 530

Genentech, Inc.

An Expanded Access Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic

Conditions: HER2-positive Breast Cancer

This single arm, multicenter study provides the pertuzumab and trastuzumab fixed-dosecombination formulation for subcutaneous injection (PH FDC SC) administered at home by ahome health nursing provider for patients with human epidermal growth factor receptor2-positive (HER2+) breast cancer who have completed concurrent chemotherapy withpertuzumab (Perjeta) and trastuzumab (Herceptin) by intravenous administration (P+H IV)and are currently receiving or will be receiving maintenance therapy with P+H IV, PH FDCSC, or trastuzumab SC in the clinic. The main objective is to enable continuity of careduring the COVID-19 pandemic.This study will enroll approximately 200 patients in the United States.Participants with early or metastatic HER2+ breast cancer will be enrolled in this study.Participants with metastatic HER2+ breast cancer will receive treatment every 3 weeks andcontinue treatment unless early cessation is necessary due to disease recurrence, diseaseprogression, unacceptable toxicity, participant withdrawal of consent, or per physician'srecommendation. Participants with early HER2+ breast cancer will receive PH FDC SC tocomplete 1 year (up to 18 cycles) of dual blockade, including the P+H IV, PH FDC SC, ortrastuzumab SC they received prior to enrolling in this study, unless early cessation isnecessary due to disease recurrence, disease progression, unacceptable toxicity,participant withdrawal of consent, or per physician's recommendation.A remote cardiac surveillance substudy will be optional for patients enrolled at selectsites.The Sponsor may decide to terminate the study when the COVID-19 pandemic is no longer arisk for this patient population.

Jewish General Hospital

First Level Socio-geriatric Evaluation: ESOGER Databank

Conditions: COVID, Social Isolation, Anxiety, Frailty

Coronavirus disease 2019 (COVID-19) is an infectious disease. Physical distancing is oneof the most effective ways to reduce the spread of COVID-19, but this key preventionintervention may have adverse consequences on older adults living at home. Screeningolder adults living at home and at risk for adverse consequences of physical and socialdistancing is, therefore, a priority in order to prevent their occurrence. ESOGER("Evaluation Social et GERiatrique") is a clinical tool designed to: 1) screen therisk-levels for adverse consequences related to COVID-19 physical distancing and 2) tocontinue appropriate preventive interventions in older adults living at home includingfrail older patients and older community dwellers. Experience cumulated during the pasttwo weeks revealed that ESOGER could be improved, in order to be more effective andefficient for the prevention of adverse consequences related to COVID-19 physicaldistancing. This improvement is based on two key components: 1) Comments of MontrealESOGER users and 2) Analysis of data. Because at this time no information is saved andstored, there is a need to save and store ESOGER information and create the ESOGERdatabank.

Imperial College London

COVID-19 and Cancer Patients

Conditions: Cancer, SARS-COV2

Routinely collected data will be used to assess the morbidity and mortality of cancerpatients following a positive COVID-19 infection.

University of Maryland, Baltimore

Trial of Imatinib for Hospitalized Adults With COVID-19

Conditions: COVID-19

This study is a randomized Double-Blind Placebo-Controlled Trial on the Safety andEfficacy of Imatinib for Hospitalized Adults with COVID-19

Hampshire Hospitals NHS Foundation Trust

SINUS WASH Pilot Study in Adults Testing Positive for COVID-19

Conditions: Coronavirus Infection

COVID-19 is highly infectious and transmission of the virus is thought to be similar tothat of influenza which can be transferred through droplets released when a personcoughs, sneezes or talks. Studies have shown that nasal rinsing and mouth washes may bean important way to deliver treatments that could reduce the amount of a virus that ispresent in the nose and mouth. This also could mean that there is less virus available topass on to others. We want to see if the use of nose rinses and mouth washes usingPovidone-Iodine will reduce the the amount of virus in the nose and throat of people whohave tested positive for COVID-19 disease and also reduce the spread of infection withintheir household.

Shirley Ryan AbilityLab

Wearable Sensor to Monitor COVID-19 Like Signs and Symptoms

Conditions: COVID-19, Healthy Control

1. Develop a wearable sensor package to gather data on COVID-19-like signs and symptoms such as elevated body temperature, respiratory parameters, heart rate ,cough and gait. 2. Create algorithms to monitor and track changes to COVID19-like signs and symptoms for developing a better care and isolation strategies for COVID-19 pandemic.

University of California, San Francisco

Assessing the Safety of Pregnancy In the CoRonavirus (COVID-19) pandEmic

Conditions: Corona Virus Infection, COVID, Pregnancy Related, Early Pregnancy

Prospective nationwide cohort study of pregnant women enrolled early in gestation andfollowed for Covid-19 exposure and infection, with follow up of obstetrical outcomes andinfant development through the first year of life.

Imperial College London

Mechanisms of Multi-organ Failure in COVID-19

Conditions: COVID

In the United Kingdom, there are currently 138,000 confirmed patients with coronavirus,causing 18,738 deaths. Whilst the disease may be mild in the majority of patients, asignificant proportion of patients require intensive care therapy and a ventilator due tolung injury. In addition to lung injury/failure (acute respiratory distress syndrome(ARDS)), around 50% of patients admitted to intensive care develop acute kidney injury(AKI) (requiring advanced support via haemofiltration) and multi-organ failure.It is unclear why patients suffering from COVID-19 develop such severe lung injury(requiring life support or ventilation) or indeed why patients develop other organdysfunction such as kidney injury. The investigators hypothesis that this may due to anover-reaction of the immune system particularly in the lungs. This then results in therelease of various mediators and biological messengers which can be pushed into the bloodbloodstream (exacerbated by positive pressure generated by the ventilator). Thesemediators then travel, via the blood, to other organs such as the kidney where they causeinflammation and injury of cells, resulting in organ failure.The investigators would like to apply their well-established laboratory methods tofurther the scientific community's knowledge of this severe and deadly viral conditionand we hope that this would lead to the development of medication that would treat thisdeadly virus.

Centre Hospitalier Intercommunal Creteil

Use of PCR-Sars-CoV-2 in Children

Conditions: COVID-19

The VIGIL study was set up at the beginning of the pandemic, in the spring of 2020, at atime when diagnostic testing for SARS-CoV-2 had to be performed according to specificclinical criteria (even if no clinical picture suggestive of COVID had been clearlyidentified). The management of sick young children (with respiratory tract infection thatcould be attributed to COVID) by pediatricians (infectious diseases specialists,emergency physicians, general practitioners, and outpatients) was facilitated by analgorithm whose objective was to help define the indications for SARS-CoV-2 PCR andsubsequently for antigenic testing. The current technique of deep nasopharyngeal swabbing(for PCR or antigenic testing) is delicate and difficult in children, and is therefore aserious handicap for community-based screening, especially since infectious episodes arefrequent in children. Since then, nasal self-tests that can be easily used in childrenhave been commercialized and have facilitated screening.Because of the similarity between the clinical signs of respiratory tract infections inchildren, it is often impossible to distinguish between different viral respiratoryinfections and epidemics may overlap in time. However, the identification of the pathogenis the key to improve management of these infectious diseases. The VIGIL study istherefore continuing, still facilitated by the existence of an active pediatric networkexisting for 20 years. ACTIV AFPA and GPIP have created networks of hospital andambulatory pediatricians who actively participate in various observatorieshttps://www.jpeds.com/article/S0022-3476(17)31606-2/fulltext To date, these observatorieshave resulted in the publication of more than 80 articles in international journals(https://www.activ-france.com/fr/publications).

Egyptian Military Medical Services

Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory in Treating COVID-19 Disease

Conditions: Corona Virus Infection, Middle East Respiratory Syndrome (MERS), Acute Respiratory Distress Syndrome, Coronavirus Infection, COVID-19, SARS-CoV 2

The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant fortreatment and to assess the potential in reducing mortality and morbidity rates inCOVID-19 patients. The study was approved by the ethical committee of the Egyptian Centerfor Research and Regenerative Medicine in 11-5-2020.

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Status

  • Unknown status (254)
  • Recruiting (129)
  • Active, not recruiting (116)
  • Enrolling by invitation (14)
  • Not yet recruiting (11)
  • Approved for marketing (3)
  • Available (3)

Intervention Type

  • Other (159)
  • Drug (134)
  • Biological (75)
  • Diagnostic Test (51)
  • Behavioral (24)
  • Device (16)
  • Procedure (11)
  • Dietary Supplement (8)
  • Radiation (7)
  • Combination Product (5)
  • Genetic (1)

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© Reagan-Udall Foundation for the FDA