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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 60 of 116

Imperial College London

Evaluation of Humoral Immunity Following COVID-19 in Pregnancy

Conditions: COVID-19, Pregnancy Related, Influenza, Human

The proposed study is designed to investigate if and how pregnant women infected withCoronavirus Disease-19 (COVID-19) infection go on to develop long-term immunity. InDecember 2019, a group of people in Wuhan, China presented with symptoms of a pneumoniaof an unknown cause that led to the discovery of a new coronavirus called COVID-19.COVID-19 has caused a global pandemic with 7,140,000 confirmed cases and 418,000 deathsas of 13th June 2020. In the United Kingdom (UK), there have been 294,000 cases and41,662 deaths as of 13th June 2020. In humans, this infection primarily involves theupper part of the lungs, but it can also affect other organs. It causes mild symptoms inthe majority of people affected but some people can have severe infections, with someeven requiring critical care in hospital. During Severe acute respiratory syndrome(SARS), a previous coronavirus epidemic, pregnant women were disproportionately affectedwith severe illness. Understanding how the immune system responds long-term to thisinfection may hold the key to developing better vaccines and efficient treatment plans.Specialised immunity develops when individuals are infected by this and other viruses.The investigators of this study propose that, in pregnancy, this specialised immunity maynot behave effectively. This may affect their ability to develop long lasting immunityand make them more vulnerable to re-infection. In this study, the investigators aim torecruit patients across 6 groups including COVID-19 newly infected pregnant women, andpeople with differing illness severity, mild to moderate, severe/critical, no infection(controls), as well as pregnant women with influenza and those receiving influenzavaccine. The study team will compare COVID-19 in pregnancy with non-pregnant infected andwith influenza infected and vaccinated pregnant women. The study team will consentpatients in all of these groups to provide a series of blood samples at different timepoints in a 12-month period.

National Institute on Aging (NIA)

Identification and Characterization of SARS-CoV-2 Specific CD8 T Cells in Humans

Conditions: COVID-19

Background:The higher death rate from COVID-19 in the older population is associated with low CD8 Tcell counts in the blood. Researchers want to learn the status of CD8 T cells specific toSARS-CoV-2 and their changes with aging and in COVID-19. This may help to identify whyCOVID-19 is particularly lethal in the elderly and help to create an effective vaccineagainst SARS-CoV-2 in the elderly.Objective:To identify SARS-CoV-2 specific CD8 T cells in humans, and to determine their quantityand quality in people who have recovered from COVID-19.Eligibility:Maryland residents age 18 and older who have tested positive for and recovered fromCOVID-19.Design:Participants will be screened by phone. They must be able to provide a copy of theirpositive COVID-19 test result.Participants will visit the NIA/Clinical Research Unit. The visit will take about 1 hour.Laboratory tests showing a positive COVID-19 result will be verified.Participants vital signs will be checked. This will include blood pressure, temperature,pulse, and respiration. Height and weight will be measured.Participants will have a medical history and medicine review. They will complete aCOVID-19 questionnaire.Participants will have blood drawn. They will give a urine sample.Participants will give a saliva sample. They will rinse their mouth with water. Afterabout 3 minutes, they will let saliva pool in the base of their mouth and then spit intoa sterile container.Participants may be asked if they would be willing to return for optional visits at about4 months and 1 year later. They will repeat the same laboratory sampling performed at thefirst visit....

Centre Hospitalier Universitaire, Amiens

COVID-19 Serology and Immunosenescence

Conditions: COVID19, Geriatric Medicine, Seroconversion, Immunosenescence

This study aims to determine how long COVID-19 neutralizing antibodies can be detected inan elderly institutionalized population presenting fragility factors.This study also aims to stratify seroconversion by immunological profiles of the elderlypatients residing in the EHPAD. This stratification requires the measurement ofimmunological marker levels already described in immunosenescence and also involved inthe development of certain chronic infectious diseases more common in the elderlypopulation. This analysis will enable the investigators to describe an immunological,clinical and biological profile representing a patient who has developed an immunityagainst COVID 19. It will also help the investigators to understand the differentmechanisms leading to a reduced immune response after a potential administration of avaccine. Finally, it will help describe the immune profiles of elderly residents whopresented with non-severe forms of COVID-19.

University of Oxford

Investigating a Vaccine Against COVID-19

Conditions: Coronavirus

A phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidateCoronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in healthy UK volunteers.

Sanofi

First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL

Conditions: Neoplasm Malignant

Primary Objective:To determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agentin patients with relapsed and refractory multiple myeloma (RRMM) and relapsed andrefractory non-Hodgkin lymphoma (RR-NHL), and determine the recommended Phase 2 dose(RP2D)Secondary Objectives: - To characterize the safety profile of SAR442257 - To characterize the pharmacokinetics (PK) profile of SAR442257 - To assess preliminary evidence of antitumor activity

Medical University of Graz

Synbiotic Therapy of Gastrointestinal Symptoms During Covid-19 Infection

Conditions: COVID

We hypothesize that the intake of Omni-Biotic® 10 AAD can reduce intestinal inflammationand improves dysbiosis in Covid-19 disease. We further hypothesize that Omni-Biotic® 10AAD can reduce the duration of diarrhea, stool frequency, improve stool consistency,improve other gastrointestinal symptoms of Covid-19, reduce disease duration andseverity.The investigators aim to perform a randomized, double blind, placebo-controlled studyusing telemedicine in patients with Covid-19 disease.

Canadian Cancer Trials Group

Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure

Conditions: Cancer, COVID-19

The purpose of this study is to find out if immunization with IMM-101 will reduce theincidence of severe respiratory and COVID-19 infections in cancer patients.

National Cancer Institute (NCI)

Best Supportive Care With or Without Low Dose Whole Lung Radiation Therapy for the Treatment of COVID-19

Conditions: Pneumonia, Severe Acute Respiratory Syndrome, Symptomatic COVID-19 Infection Laboratory-Confirmed

This phase III trial compares low dose whole lung radiation therapy to best supportivecare plus physicians choice in treating patients with COVID-19 infection. Low dose wholelung radiation therapy may work better than the current best supportive care andphysician's choice in improving patients' clinical status, the radiographic appearance oftheir lungs, or their laboratory blood tests.

Sahlgrenska University Hospital

COPE - COVID-19 in Pregnancy and Early Childhood

Conditions: SARS-COV2, COVID-19, Pregnancy Complications, Pregnancy Preterm, Pregnancy in Diabetic, Neonatal Infection

Purpose: The emergence of a new coronavirus SARS-CoV-2 causing a novel infection in thehuman race resulting in a world-spanning pandemic came as a surprise and at a tremendouscost both for individual human lives as well as for the society and the health caresector. The knowledge on how this new infection affects both the mother and the unbornchild as well as the outcomes for the mother and the child in the long run are unknown.What is known is based on case-reports and small case-series solely. Both thecoronaviruses causing Middle East Respiratory Syndrome (MERS) and Severe AcuteRespiratory Syndrome (SARS) can cause a threat to pregnant women and their offspring,which leads to the question whether this could be the case also for SARS-CoV-2.Aims: To establish a biobank of biological material from infected as well as non-infectedpregnant women and their offspring. To combine this biobank with Swedish quality andhealth care registers, computerized patient charts and questionnaire data, enabling bothshort-term follow up, such as obstetric outcomes, as well as long-term outcomes both formother and child. To study how the pandemic situation affects both the mother and herpartner in their experience of pregnancy, childbirth, and early parenthood.Design: A national Swedish multicentre study. Women are included when they have apositive test for SARS-CoV-2 or a clinical suspicion of coronavirus disease 2019(COVID-19) (COVID-19 group). Pregnant women without COVID-19 symptoms will be included attheir routine visits (Screening group). Blood samples and other biological material willbe collected at different time-points. Additional predictors and outcomes are collectedfrom the Swedish Pregnancy Register as well as obligatory Swedish health registers. Thebiobank and its linkage to health registers through the Swedish personal identificationnumber will enable future research. Child development will be followed during the firstyear of life by questionnaires to the parents. Womens' and their partners' experience ofchildbirth and parenthood will be studied in form of questionnaires as well as in form ofinterviews.Conclusion: This project will help obstetricians and neonatologists better recognizeclinical manifestations of the virus, identify possible risk factors during pregnancy andtailor therapies alongside providing right level of surveillance and management duringpregnancy, delivery, and child health care.

University Hospital, Grenoble

COVID-19: Respiratory and Sleep Follow-up

Conditions: COVID-19

The current project is a prospective, multicentric cohort study aiming at amultidisciplinary assessment (pulmonary, cardiometabolic, sleep and mental health) of theconsequences of infection by SARS-CoV-2, 3 months after the diagnosis in order to bettercharacterize these complications. 400 patients with a positive diagnosis of SARS-CoV-2will be included in the study 3 months after their diagnosis: They will be followed at 6months, 1 year, 3 years, and 5 years, as function of their after-effects discovered at 3months and their evolution.

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Status

  • (-) Active, not recruiting (116)

Intervention Type

  • Drug (37)
  • Other (27)
  • Biological (17)
  • Diagnostic Test (14)
  • Behavioral (5)
  • Procedure (5)
  • Device (2)
  • Dietary Supplement (2)
  • Radiation (2)

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