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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 10 of 48

ProgenaBiome

A Study to Explore the Role of Gut Flora in COVID-19 Infection

Conditions: Gut Microbiome, Gastrointestinal Microbiome, COVID, COVID-19, Corona Virus Infection, Coronavirus, Coronaviridae Infections, Coronavirus 19, Coronavirus-19, COVID 19

This study seeks to determine whether the virus which causes COVID-19, SARS-CoV-2, isshed in the stools of patients who are infected.

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.

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.

Centre Hospitalier Universitaire de Besancon

Study of Specific Viral Immune Responses Induced by SARS-CoV-2 (COVID-19)

Conditions: SARS-CoV-2 Infection

SARS-CoV-2, has caused an international outbreak of respiratory illness termed Covid-19.The investigators used peptides derived from SARS-CoV-2 virus, to study viral-specificimmune responses. COV-CREM is a French prospective monocentric study that will evaluateviral-specific cell responses in positive patients for SARS-CoV-2 on the basis of(RT-PCR) assay performed in respiratory tract sample tested by our local Center forDisease Control.

West Virginia University

Convalescent Plasma Collection and Treatment in Pediatrics and Adults

Conditions: COVID19, Coronavirus Infection, Coronavirus, Virus Diseases, RNA Virus Infections

This is a prospective study, involving contacting potential plasma donors and the use oftheir plasma to help fight off infections of those suffering from COVID19 in accordanceto collection guidelines for plasma and FDA IND requirement. This study will include upto 240 participants potentially receiving convalescent plasma and up to 1000 potentialdonors.There are 3 basic arms to the study: mild, moderate and severe/critical severity. All 3severity groups are eligible for enrollment, but mild severity will not be given plasmaunless there is progression. Moderate severity will given up to 1 unit of plasma andsevere/critical severity up to 2 units. There is no placebo group, however given theexcepted issues of shortages of plasma, intention to treat will be used for analysis.

Centre Hospitalier Universitaire, Amiens

Thrombo Embolic Events in Hospitalized Patients With Covid-19 Serious Acute Pneumopathy

Conditions: COVID-19, Hemostasis, Coagulation

The understanding of haemostasis and inflammation cross-talk has gained considerableknowledge during the past decade in the field of arterial and venous thrombosis. Complexand delicately balanced interaction between coagulation and inflammation involve allcellular and humoral components.Elements of the coagulation system such as activated thrombin, fibrinogen or factor Xamay increase inflammation by promoting the production of proinflammatory cytokines,chemokines, growth factors and adhesion molecules that lead to a procoagulant stateamplifying the pathological process. Recent evidence supports inflammation as a commonpathogenic contributor to both arterial and venous thrombosis, giving rise to the conceptof inflammation induced thrombosis.Patients with infection of COVID-19 and severe pneumoniae seem to have higher risk ofthromboembolism. The purpose of this project is to analyze hemostasis and coagulation ofevery hospitalized patient with infection of COVID-19.Blood sample for coagulation and hemostasis analysis will be collected on every patienthospitalized in Amiens hospital for COVID-19 infection. Thrombin time, factors V and II,fibrin/fibrinogen degradation products, antithrombin will be assessed every week.Anticardiolipin, anti-beta2 glycoprotein I and anti-annexin A2 antibodies IgG and IgM atday of admission and at fourth week after admission will be assessed. SARS-CoV2 viralload and serodiagnosis will be performed at the same time. At the same time venousultrasound to diagnose thrombosis will be performed.

Universitaire Ziekenhuizen KU Leuven

In-depth Immunological Investigation of COVID-19.

Conditions: Coronavirus Infections

The COntAGIouS trial (COvid-19 Advanced Genetic and Immunologic Sampling; an in-depthcharacterization of the dynamic host immune response to coronavirus SARS-CoV-2) proposesa transdisciplinary approach to identify host factors resulting in hyper-susceptibilityto SARS-CoV-2 infection, which is urgently needed for directed medical interventions.

Mayo Clinic

Viral Infection and Respiratory Illness Universal Study[VIRUS]: COVID-19 Registry

Conditions: Coronavirus

Researchers are creating a real time COVID-19 registry of current ICU/hospital carepatterns to allow evaluations of safety and observational effectiveness of COVID-19practices and to determine the variations in practice across hospitals.

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.

University Hospital, Bordeaux

COVID-19 Biological Samples Collection

Conditions: Infection Viral

The coronavirus disease 2019 (COVID-19) outbreak is now considered as a public healthemergency of international concern by the World Health Organization.In the context of the health emergency, research on the pathogen (the SARS-CoV-2coronavirus), the disease and the therapeutic care is being organized. Research projectsrequire the use of biological samples. This study aims at setting up a collection ofbiological samples intended for application projects in any discipline.The main objective of the study is to collect, process and store biological samples frompatients and caregivers infected with SARS-CoV-2 (COVID-19) at the biological ressourcescenter of the Bordeaux University Hospital.

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Status

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Intervention Type

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  • Biological (5)
  • Drug (3)
  • Behavioral (2)
  • Diagnostic Test (1)

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