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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 10 of 76

Saglik Bilimleri Universitesi

PAI-1 Levels and Predicting Covid-19 Patients' Prognosis

Conditions: Covid-19 Positivity Confirmed With PCR Positivity in the Nasopharyngeal Swab, Symptomatic Covid -19 Positive Patients Who Require Hospitalization, Patients Who Did Not Vaccinate Against Covid-19, Patients Among 20 to 90 Years of Age, Healthy Control Patients of the Same Age

The primary aim of our study is to understand the effects of Covid-19 disease on vascularinflammation and coagulation cascade, and secondarily, to investigate its utility inpredicting disease prognosis by analyzing serum PAI-1 levels in patients with differentseverity. The study is planned as a prospective, cross-sectional study that will includepatients admitted to Covid-19 services between January 18, 2021, and August 30, 2021. Atotal of 80 volunteers will be enrolled in the trial whose age, gender, and BMI areplanned to be matched.The study will be conducted on four groups. Group 1 (n=20; withmild symptoms), Group 2 (n=20; with moderate symptoms), Group 3 (n=20; with severesymptoms) and Group 4 (n=20; Control group).All participants who accepted the study will have their sociodemographic data, medicalhistory, and vital signs (respiratory rate, saturation, temperature, and blood pressurevalues) recorded at the start of the study. The pulmonologist in the study will alsoclassify the patient group's chest X-ray and chest tomography findings and the thymusgland dimensions. After all four groups of patients have given their consent for thestudy, a sample of 5cc blood will be obtained once for the PAI-1 analysis.

Universita di Verona

RESPOND: Improving the Preparedness of Health Systems to Reduce Mental Health and Psychosocial Concerns Resulting From the COVID-19 Pandemic

Conditions: Psychological Distress

This randomized controlled trial will evaluate the implementation and(cost-)effectiveness of the culturally and contextually adapted Doing What Matters intimes of stress (DWM) and Problem Management Plus (PM+) stepped-care programs amongstasylum seekers, refugees, and/or migrants living in Italy. Outcomes include mentalhealth, resilience, wellbeing, health inequalities, and costs to health systems.

Afyonkarahisar Health Sciences University

Pain, Fatigue and Life Quality in COVID-19 Patients

Conditions: COVID-19 Pneumonia, Pain, Fatigue, Quality of Life

The aim in this study is to evaluate pain, fatigue and quality of life in patients withCovid-19 pneumonia in long-term follow-up and to investigate their relationship withpneumonia severity, age, presence of comorbidity and depression level.

Cumhuriyet University

The Effect of Virtual Reality Exercises on Patients With Post-SARS-CoV-2 Syndrome

Conditions: COVID19

The aim of this study is to investigate the effectiveness of virtual reality exercises onpain, cardiopulmonary capacity, mood and quality of life in patients with post-COVIDsyndrome.

Jesús R. Requena

Echinacea Drug for Covid-19

Conditions: COVID19

The main objectives of ECCO-2 are: 1) Efficacy: to study whether EQUINACEA ARKOPHARMA,hard caplets containing cryogenized root of the plant Echinacea purpurea, show animprovement of the clinical manifestations and disease course in ambulatory patients withcovid-19 with a respiratory presentation and not requiring hospitalization (i.e., mildcovid-19). The drug being evaluated will be added as a supplement of the standardtreatment, with its current recommended dose for treatment of the common cold. 2) Safety:to determine that the incidence of adverse events is not higher than that seen with thestandard treatment applied in each case.

University of Geneva, Switzerland

Medical Triage in a Time of Scarce Resources.

Conditions: Morals, COVID19, Ethics, Narrative

The XPHI-COVID-2 randomized study aims to investigate the moral choices in a context ofscarce resources.The participants are asked to complete the questionnaire of the Oxford UtilitarianismScale and are exposed to medical triage dilemmas.Participants are randomized between a group with reading of ethical guidelines and agroup without reading of ethical guidelines, before they are asked to complete thequestionnaire and being exposed to triage dilemmas.

McMaster University

COVID-19 Related Lung Ventilation and Perfusion Injury

Conditions: COVID-19, Asthma, Healthy

Little is currently known about the immediate and long-term effect of COVID-19 on lungventilation (delivery of air to the lungs) and lung perfusion (delivery of blood to thelungs). Some people who survive COVID-19 may have lung ventilation and/or perfusioninjury that persists following COVID-19 recovery. This lung injury may be related toinflammation in the lung, breathlessness, exercise limitation and reduced quality oflife. Therefore, towards the goal of understanding the effects of COVID-19 on lunghealth, the purpose of this study is to characterize and understand the clinicalrelevance of COVID-19 related lung ventilation and perfusion injury and associatedinflammatory status, ≤4 weeks and 6-months following COVID-19 recovery in an asthmaticand healthy population. To do this, an asthmatic and healthy population who have, andhave not, been previously diagnosed with COVID-19 will be studied.

Centre Hospitalier Universitaire, Amiens

Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients

Conditions: COVID19, Neurological Manifestations, Brain Damage

Viral pandemics, such as HIV and SARS-Cov-V1, have shown that they can lead to acute and/ or delayed neurological complications. At the actual context of the pandemicCoronavirus disease 2019 (COVID-19), neurological manifestations seem to be confirmedsince in 85% of COVID-19 patients, present neurological symptoms, including anosmia,ageusia, periorbital pain, dizziness, fatigue, even moderate headache, moderate memoryand/or behavioral disorders.However, these neurological manifestations are not well studied and their radiologicalfeatures are not well described. It is therefore important to assess these potentialneurological complications in COVID-19 patients. To the investigator knowledge, there isno previous study in the literature describing spectral brain changes in COVID +patients. Thus, the goal of this work is to describe the radiological semiology using MRIand particularly Magnetic Resonance Spectroscopic (MRS) biomarkers in the evaluation ofacute and / or delayed brain damage in COVID + patients presenting a neurologicalmanifestations that are initially related to the cranial nerves damage.

University Hospital, Strasbourg, France

COVID-19 Prevalence in HIV-infected Patients

Conditions: HIV Infections

North-east area of France was hit in February 2020 by the new coronavirus disease, moreseverely than other French regions. Factors affecting the evolution of the disease andits severity have been quickly identified, among them figuring different kinds of immunedeficiency. Even if nowadays HIV infection is usually well controlled by ARV drugs, thosepatients with uncontrolled viral load and/or low CD4 cell counts, remain at higher riskof severe COVID infection. In this context, the primary objective of our study is aimedat evaluating the prevalence of SARS-CoV-2 antibodies in a cohort of HIV-infectedpatients followed-up in an HIV-infection care center. Secondary objectives are:evaluating whether the antibodies are protective or not, the kinetic of these antibodies,and HIV associated factors with the presence of antibodies.

M.D. Anderson Cancer Center

Novel Point-of-Care Diagnostic Test for SARS-CoV-2 (COVID-19)

Conditions: Covid-19 Infection

This study investigates a new diagnostic test in detecting SARS-CoV-2, the virus thatcauses the disease COVID-19. This may help to improve testing for COVID-19.

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Status

  • (-) Unknown status (76)
  • Recruiting (48)
  • Active, not recruiting (27)
  • Not yet recruiting (5)
  • Enrolling by invitation (3)

Intervention Type

  • (-) Other (76)
  • Drug (64)
  • Biological (35)
  • Diagnostic Test (29)
  • Behavioral (10)
  • Device (8)
  • Procedure (6)
  • Combination Product (5)
  • Dietary Supplement (4)
  • Radiation (3)

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