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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. Animal Health & Veterinary Medicine
          1. Antimicrobial Use in Food Animals
          2. Industry SWOT Analysis
        2. Expanded Access
          1. E-request App
          2. Navigator
          3. Resources for COVID-19
        3. FDA Patient Listening Sessions
        4. 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. Column 2
        1. Improving Access to FDA Information
          1. Understanding FDA & FDA-Regulated Products
          2. Improving Access to Publicly Available FDA Information
        2. Research
          1. About
          2. Cross-Sectoral Health Threats
          3. IMEDS
          4. Post Market Research
          5. RAISE
          6. Real World Data
          7. Regulatory Science Accelerator
        3. Substance Use Disorders
  • News and Events
      1. Innovations in Regulatory Science & Policy Awards
      2. 2024 Annual Public Meeting
      3. Events
      4. News
      5. Publications
  • 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 480 of 530

Jessa Hospital

Minimal Invasive Autopsies to Investigate Changes in Deceased COVID-19 Patients

Conditions: COVID-19

Rationale In a very short time corona virus disease 2019 (COVID-19) has become a pandemicwith high morbidity and mortality. The main cause of death is respiratory failureincluding acute respiratory distress syndrome, however the exact mechanisms and otherunderlying pathology is currently not yet known. In the current setting of the COVID-19pandemic complete autopsies seem too risky due to the risk of SARS CoV-2 transmission.Yet, as so little is known, additional histopathological, microbiological and virologicstudy of tissue of deceased COVID-19 patients will provide important clinical andpathophysiological information. Minimal invasive autopsy combined with postmortem imagingseems therefore an optimal method combining safety on the one hand yet provingsignificant information on the other.This study aims to determine the cause of death and attributable conditions in deceasedCOVID-19 patients. This will be performed using post-mortem CT-scanning plus CT-guidedMIA to obtain tissue for further histological, microbiological and pathologicaldiagnostics. In addition, the pathophysiology of COVID-19 will be examined by furthertissue analysis.

Consorci Sanitari de Terrassa

Influenza Vaccination, ACEI and ARB in the Evolution of SARS-CoV2 Infection

Conditions: COVID19, Influenza Vaccination, ACE Inhibitors, ARB, Antihistamine Allergy, Amantadine

Some authors have proposed the use of the flu vaccine to reduce the severity of COVID-19cases, while some have proposed the use of ACE Inhibitors (ACEI) or Angiotensin Receptorblockers (ARB), since this virus shares hemagglutinin as a transmission mechanism andacts on the ACE2 enzyme during infection.Other authors described how none of the elderly patients receiving antihistamines andazythromycin in two nursing homes in Toledo -Spain- during the first wave died or neededhospital admission, even considering that 100% of residents had a positive serologicaltest after that wave. Other authors have described a positive evolution in patientsreceiving amantadine for their Parkinson's disease.The aim is to evaluate whether the admitted patients who are previously vaccinated orthose who were already receiving these treatments showed a better evolution.

Columbia University

ARMOR Study: COVID-19 Seroprevalence Among Healthcare Workers

Conditions: COVID-19, Coronavirus Infection, Coronavirus

The novel coronavirus (SARS-CoV-2) has spread all around the world and testing has poseda challenge globally. Health care providers are highly exposed and are an important groupto test. On top of these concerns, health care workers are also stressed by the needs onresponders in the COVID-19 crisis. The investigators will look at different ways tomeasure how common COVID-19 is among health care workers, how common is the presence ofantibodies by serological tests (also known as serostatus). The investigators willdescribe health worker mental and emotional well-being and their coping strategies intheir institutional settings. Lastly, the investigators will describe how knowingserostatus can affect individuals' mental and emotional well-being and how to cope in themidst of the COVID-19 response. This will help to how to better test and help healthcareworkers in the COVID-19 pandemic and prepare for possible future outbreaks.

Emory University

Trans Thoracic Manipulation of Ventilation/Perfusion: the V/Q System

Conditions: Acute Respiratory Distress Syndrome, COVID-19

The purpose of this pilot study is to measure the impact of non-invasive pneumaticmanipulation of transthoracic pressure on oxygenation in patients with Acute RespiratoryDistress Syndrome (ARDS) due to Coronavirus Disease 2019 (COVID 19) who are on mechanicalventilator support. This will be achieved by a pneumatic Vest placed around the chestwall of consenting patients who meet inclusion criteria. The Vest is essentially anon-invasive segmental device placed upon the anterior and posterior right and leftaspects of the chest wall. The researchers have the ability to inflate and deflate thechambers of the Vest to achieve preset pressures as determined by the protocol andobserve the patient's physiological response. Participants will have up to four hours ofintervention with the study intervention, followed by 1 hour of post-interventionobservation.

University Medicine Greifswald

Screening for COVID-19 and Monitoring of Serological Responses to SARS-CoV-2 in Healthcare Workers

Conditions: SARS-CoV-2

The main objectives of this study are 1) to establish the prevalence of SARS-CoV-2 inasymptomatic healthcare workers (HCWs) in an early phase of community spread as well as2) to monitor the future spread of the disease by assessing serological responses toSARS-CoV-2 in symptomatic and asymptomatic HCWs over time and 3) to improve theassessment of the immune response and its protective effect as well as the assessment ofinfectivity of affected HCWs and 4) to evaluate the value and significance of antibodyformation and serological antibody tests and 5) to be able to evaluate possible futurepreventive and / or therapeutic approaches against SARS-CoV-2, e.g. to assess vaccinationeffects

University of Manchester

Immune Cells in Inflammatory Arthritis With Coronaviruses, Including COVID-19

Conditions: SARS Virus

A team at the University of Manchester are developing a test that tcould be helpful indetecting immunity to the Coronavirus (which causes the COVID-19 disease) in participantswith inflammatory arthritis. It is based on a flu assay has already developed; the teamwill replace the flu antigen with a Coronavirus antigen to see if it is effective.This project aims to develop a test to see if people who have had the virus havedeveloped immunity to it. This could help to predict who might or might not get thedisease a second time, who should stay at home to be protected from potential infectionor who will not develop any symptoms, even if exposed to the virus.When vaccination trials against the Coronavirus will be launched, this test could alsohelp to see if the vaccine is effective.

Swiss National Science Foundation

Global Mental Health of Urban Mothers

Conditions: Perinatal Depression, COVID19, Anxiety, PTSD, Pregnancy Related

Mental health disorders are common during pregnancy and the postnatal period, and canhave serious adverse effects on the well-being of woman and child. Every tenth woman hasdepressive symptoms and 5% suffer major depression during pregnancy. The consequences forglobal mental health due to the novel coronavirus disease, COVID-19, are likely to besignificant and may have long-term impact on the global burden of disease. Pregnant womenmay be particularly vulnerable due to partial immune suppression. Besides physicalvulnerability, the women could be at increased risk of mental health problems, such asanxiety, depression, and post-traumatic stress disorder (PTSD), due to social distancingleading to less support from the family and friends, and in some cases, partners notbeing allowed to be present during prenatal visits, labor and delivery. Furthermore, manypregnant women may feel insecure and worried about the effect of COVID-19 on their unbornchild, if the women get infected during pregnancy. Today, young urban women are used toutilizing internet services frequently and efficiently. Therefore, providing mentalhealth support to pregnant women via web-based support may be effective in amelioratingtheir anxiety/depression and reduce the risk of serious mental health disorders leadingto improved maternal and perinatal outcomes.

Instituto Nacional de Perinatologia

Local Thermotherapy for Patients With Mild-to-moderate COVID-19

Conditions: COVID-19, Thermotherapy

The etiological agent of the current pandemic is a (+)ssRNA virus. SARS-CoV-2 isinfecting thousands of people in the world with a fatality rate that varies from 0.1 to5% in affected countries, thereby causing enormous economic losses. Few antibiotics haveshown any efficacy in their combat, but have not yet proven adequate to stop the spreadof the disease, nor are there any approved vaccines at the moment. From experiments inplants ongoing infections by RNA viruses, using thermotherapy, which is the applicationof heat at a temperature between 35-43 °C, the investigators know that raising thetemperature affects the transcription of viral proteins due to the formation of small RNAmolecules that interrupt the replication process by grouping in specific regions of theRNA molecule, preventing and inhibiting transcription. These small molecules are calledsmall interfering RNAs (siRNAs). This feature has been used through thermotherapy inhumans to combat the rapid replication of cells (i.e. cancer cells), attack cellsinfected by RNA viruses, and in the treatment of some parasitic infections.There arevarious commercially available devices for thermotherapy use in humans; they are mainlybeing used to ease muscle pain. They work by increasing the temperature in the rangerecommended for thermotherapy in humans 39-43 ° C. Therefore, the investigators considerthis treatment modality can be used to aid in the elimination of SARS-CoV-2 from thehuman body, decreasing viral load, which could allow the immune system time for itscontrol and elimination.

BioClever 2005 S.L.

Clinical Impact of BACTEK-R in Subject With Mild Pneumonia Due to COVID-19 Infection

Conditions: COVID-19

The purpose of the study is to confirm if BACTEK-R (MV130) provides clinical benefit insubject with mild pneumonia (CURB-65≤2) by COVID-19 admitted to the Hospital.

National Cancer Institute (NCI)

Investigation of the B- and T-cell Repertoire and Immune Response in Patients With Acute and Resolved COVID-19 Infection

Conditions: COVID-19

Background:People who get infected with COVID-19 have an unpredictable risk to worsen and die. Thismakes it hard to decide who can quarantine at home and who should be treated at ahospital. Researchers think the risk may be related to how a person s B and T cellsrespond to the virus. B and T cells are the major components of a person s immuneresponse. B and T cells responding to the virus with a favorable pattern may lead torecovery, and this favorable pattern may be helpful to establish. If people in a vaccinetrial get this same favorable pattern when responding to a vaccine, this may be a usefulearly signal that the vaccine will be successful.Objective:To examine how immune cells respond to COVID-19 infection.Eligibility:Adults ages 18 and older who have a confirmed or suspected COVID-19 infection or hadCOVID-19 in the past.Also, healthy donors with no suspected COVID-19 infectionDesign:Participants will be screened with medical record review.Participants will be tested with a research assay to determine who was infected withCOVID-19 and who was not. This test will be used to understand research results, not toadvise patients.Participants with active infection must be isolated, usually in a hospital.Other participants may give blood samples at NIH or at their local doctor s office orlab.Participants may give blood samples up to three times a week for a total of ten times,and may also give blood samples after starting a vaccine trial.Participants will be contacted by phone or email every 2 months for up to 2 years.

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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