Skip to main content
Home
  • About
    • Board of Directors
    • Our Staff
    • Annual Reports
    • Policies
    • Fellowship
    • Careers
  • Projects
    • Column 1
      • Advancing Regulatory Science
        • Oncology Multi-Regional Clinical Trials
        • Rare Disease Innovation Roundtable
      • Animal Health & Veterinary Medicine
        • Antimicrobial Use in Food Animals
        • Cross-Sectoral Health Threats
        • Industry SWOT Analysis
      • Expanded Access
        • E-request App
        • Navigator
        • Resources for COVID-19
      • FDA Patient Listening Sessions
    • Column 2
      • Food & Nutrition
        • About
        • Food Traceability
        • Healthy Rule Roundtables
        • Nutrition Facts Label
        • Produce Safety Stakeholder Dialogue
        • Retail Dietitian Toolkit
      • Improving Access to FDA Information
        • Understanding FDA & FDA-Regulated Products
        • Improving Access to Publicly Available FDA Information
      • Research
        • About
        • IMEDS
          • IMEDS Inquiry
        • Post Market Research
        • RAISE
        • Real World Data
        • Regulatory Science Accelerator
    • Substance Use Disorders
  • News and Events
    • Innovations in Regulatory Science & Policy Awards
    • Events
    • News
    • Publications
    • 2026 Annual Public Meeting
  • Expanded Access eRequest
  • facebook
  • twitter
  • linkedin
  • youtube
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 30 of 51

Lahore General Hospital

Waxing and Waning of Serum SARS CoV-2-IgG Level in COVID-19 Exposed Population

Conditions: COVID19

This study will define the kinetics of IgG responses to both N and S proteins in thesubjects who suffered from COVID 19 and then had recovered and those who were previouslyundiagnosed but were seropositive. These subjects will be followed for four months toevaluate the levels of antibodies in these people.

Henry Ford Health System

Sustained Immunity to COVID-19 as Measured by SARS-CoV-2 Serology Assays

Conditions: COVID19

The primary objective is to assess the ability of COVID-19 IgG and IgM assays to detectan immune response in COVID-19 patients in the Henry Ford Health System (HFHS), bothduring hospitalization and over the following 12 months.

Centre Hospitalier Universitaire de Nīmes

CT Biomarkers Identification by Artificial Intelligence for COVID-19 Prognosis

Conditions: COVID-19

The study hypothesis is that low-dose computed tomography (LDCT) coupled with artificialintelligence by deep learning would generate imaging biomarkers linked to the patient'sshort- and medium-term prognosis.The purpose of this study is to rapidly make available an early decision-making tool(from the first hospital consultation of the patient with symptoms related to SARS-CoV-2)based on the integration of several biomarkers (clinical, biological, imaging by thoracicscanner) allowing both personalized medicine and better anticipation of the patient'sevolution in terms of care organization.

Universidade Nova de Lisboa

COVID-19 and Pregnancy Outcomes

Conditions: Coronavirus Infection, Pregnancy Complications, Vertical Transmission of Infectious Disease, Breastfeeding, Neonatal Infection

This is a multicenter prospective study that aims to investigate the clinical impact ofSARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.

Cambridge University Hospitals NHS Foundation Trust

RASCALS: Rapid Assay for Sick Children With Acute Lung Infection Study

Conditions: Lower Respiratory Tract Infection, Ventilator Associated Pneumonia, COVID19

Lower Respiratory Tract infections are a common cause of admission to the intensive careunit. Children routinely receive antibiotics until the tests confirm whether theinfection is bacterial or viral. The exclusion of bacterial infection may take 48 hoursor longer for culture tests on biological samples to be completed. In many cases, theresults may be inconclusive or negative if the patient has already received antibioticsprior to the sample being taken.A rapid assay to detect the most likely cause of infection could improve the speed withwhich antibiotic therapy is rationalised or curtailed.This study aims to assess whether a new genetic testing kit which can identify thepresence of bacteria and viruses within hours rather than days is a feasible tool inimproving antibiotic prescribing and rationalisation of therapy in critically illchildren with suspected lower respiratory tract infection.

Sheba Medical Center

Daily Home Spirometry for Early Detection of Pulmonary Complications in Patients With COVID19

Conditions: COVID 19

The aim of this preliminary study is to describe the potential decline in forcedexpiratory volume in 1 second (FEV1) or forced vital capacity (FVC) as measured by homespirometry in high-risk subjects infected with COVID-19. We hypothesize that themagnitude of such a decline in FEV1 and/or FVC may be associated with clinicaldeterioration and hospitalization. The study will ultimately inform a larger subsequentRCT that will evaluate the efficacy of home spirometry in the early detection (prerespiratory symptoms) of respiratory complications and therefore prompt early medicalattention which is a key for improving outcome.

Richmond Pharmacology Limited

Serological and PCR Testing for COVID-19

Conditions: COVID-19

Richmond Research Institute (RRI) is applying existing and new COVID-19 PCR and antibodytests to help develop methodologies which provide fast and accurate results. Infectionwith coronavirus (SARS-CoV-2) is currently a worldwide pandemic and reliable testing forCOVID-19 is crucial to understand who is infected and therefore a risk to others byspreading the infection. RRI are currently carrying out the following tests:A. Using a membrane-based immunoassay to detect IgG and IgM antibodies to SARS-CoV-2 inwhole blood, serum or plasma specimens helps to assess whether an individual haspreviously had the virus and is potentially immuneB. Polymerase Chain Reaction (PCR) testing using an established method to check foractive SARS-CoV-2 infections.C. Quantification of anti-SARS-CoV-2 IgG and IgM antibodies in whole blood samples.The above tests are being used by RRI to follow infections (PCR) and immunity (IgG) intheir workforce, as well as their families (including children) and visitors to theirsite.Collecting this data allows the gathering of epidemiological data on SARS-CoV-2 includingincidence, prevalence, information on asymptomatic carriers and efficacy of vaccination.Furthermore, identifying individuals that are infected with SARS-CoV-2 has greatpotential to improve health outcomes by allowing infected individuals to seek the correctmedical treatment as well as self-isolate and reduce transmission.

LumiraDx UK Limited

Research & Evaluation of LumiraDx SARS-CoV-2 (COVID-19) Point of Care Ab Test

Conditions: COVID19

Evaluation of the agreement between fingerstick samples, venous blood, serum and plasmasamples when using the LumiraDx SARS-CoV-2 Ab Test against the reference method, usingstandard qualitative comparison techniques.

Ankara University

Comparison of Cardiopulmonary Fitness Level With Normal Values After COVID-19

Conditions: COVID 19

COVID-19 (Coronavirus disease 2019) is a new infectious disease caused by a virus namedas SARS-CoV2 (Severe Acute Respiratory Syndrome Coronavirus-2). Although it can have adevastating effect on many organs, the respiratory tract is particularly affected. In thecourse of the disease, a wide clinical spectrum is observed, from flu-like illness tolung failure. Some of the patients who survived the disease continue to have problemssuch as shortness of breath, fatigue, decrease in walking distance, decrease inparticipation in daily life activities. These problems suggest that the effects onrespiratory and cardiac functions continue even after the disease ends. This study wasdesigned to demonstrate the effects and extent of COVID-19 on cardiopulmonary capacity.

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.

Pagination

  • First page « First
  • Previous page ‹‹
  • Page 1
  • Page 2
  • Current page 3
  • Page 4
  • Page 5
  • Page 6
  • Next page ››
  • Last page Last »

Status

  • Unknown status (29)
  • Active, not recruiting (14)
  • Recruiting (8)

Intervention Type

  • (-) Diagnostic Test (51)
  • Other (6)
  • Biological (1)

Subscribe for updates from the Reagan-Udall Foundation for the FDA

Subscribe
(202) 849 - 2075
1333 New Hampshire Ave, NW
Suite 420
Washington, DC 20036
admin@reaganudall.org
  • facebook
  • twitter
  • linkedin
  • youtube

© Reagan-Udall Foundation for the FDA
© Reagan-Udall Foundation for the FDA