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Home
  • About
      1. Board of Directors
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      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 14

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.

Luxembourg Institute of Health

Luxembourg Cohort of Positive Patients for COVID-19: a Stratification Study to Predict Patient Prognosis

Conditions: COVID19

Predi-COVID is a prospective cohort study composed of people positively tested forCOVID-19 in Luxembourg, followed digitally for monitoring participants' health evolutionand symptoms at home. Participants will be actively followed for 14 days from the time ofconfirmation of diagnosis, whether they are at the hospital or at home in isolation orquarantine. Short evaluations will be also performed at week 3 and week 4 and thenmonthly for a period up to 12 months to assess potential long term consequences ofCOVID-19. A subsample of 200 participants will be contacted to integrate complementaryclinical data and collect samples.The study aims at identifying factors associated with the COVID-19 disease severity.COVID-19 patients with severity criteria will be compared to patients with mild diseasemanaged at home.A deep phenotyping related to the symptoms of the disease as well as biosampling allowingfor laboratory-based and computational analytics will be performed.

University of Oxford

Randomised Evaluation of COVID-19 Therapy

Conditions: Severe Acute Respiratory Syndrome

RECOVERY is a randomised trial of treatments to prevent death in patients hospitalisedwith pneumonia.The treatments being investigated are:COVID-19: Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin,Colchicine, IV Immunoglobulin (children only), Convalescent plasma,Casirivimab+Imdevimab, Tocilizumab, Aspirin, Baricitinib, Empagliflozin, Sotrovimab,Molnupiravir, Paxlovid or Anakinra (children only)Influenza: Baloxavir marboxil, Oseltamivir, Low-dose corticosteroids - DexamethasoneCommunity-acquired pneumonia: Low-dose corticosteroids - Dexamethasone

University of Edinburgh

DEFINE - Evaluating Therapies for COVID-19

Conditions: COVID-19

COVID-19 is a community acquired pneumonia caused by infection with a novel coronavirus,SARS CoV2 and is a serious condition with high mortality in hospitalised patients, forwhich there is no currently approved treatment other than supportive care. Urgentinvestigation of potential treatments for this condition is required.This protocol describes an overarching and adaptive trial designed to provide safety,pharmacokinetic (PK)/ pharmacodynamic (PD) information and exploratory biologicalsurrogates of efficacy which may support further development and deployment of candidatetherapies in larger scale trials of COVID-19 positive patients receiving normal standardof care.Given the spectrum of clinical disease, community based infected patients or hospitalisedpatients can be included. Products requiring parenteral administration will only beinvestigated in hospitalised patients. Patients will be divided into cohorts, a)community b) hospitalised patients with new changes on a chest x-ray (CXR) or a computedtomography (CT) scan or requiring supplemental oxygen and c) hospitalised requiringassisted ventilation. Participants may be recruited from all three of these cohorts,depending on the experimental therapy, its route of administration and mechanism ofaction. The relevant cohort(s) for any given therapy will be detailed in thetherapy-specific appendix.Candidate therapies can be added to the protocol and previous candidates removed fromfurther investigation as evidence emerges. The trial will be monitored by an independentData Monitoring Committee (DMC) to ensure patient safety.Each candidate cohort will include a small cohort of patients randomised to candidatetherapy or existing standard of care management dependent on disease stage at entry.Cohort numbers will be defined in the protocol appendices.This is a Phase IIa experimental medicine trial and as such formal sample sizecalculations are not appropriate.

QuantumLeap Healthcare Collaborative

I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients

Conditions: COVID-19

The goal of this project is to rapidly screen promising agents, in the setting of anadaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase2 platform design, agents will be identified with a signal suggesting a big impact onreducing mortality and the need for, as well as duration, of mechanical ventilation.

University of Liege

Mesenchymal Stromal Cell Therapy for Severe Covid-19 Infection

Conditions: Coronavirus Infection

The overall objective of the study is to evaluate the safety and efficacy of MSC therapycombined with best supportive care in hospitalized patients with COVID-19.

National Cancer Institute (NCI)

Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment of Moderate, Severe or Critical Pneumonia

Conditions: Covid-19 Infection, COVID-19-Associated Acute Respiratory Distress Syndrome, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Symptomatic COVID-19 Infection Laboratory-Confirmed

This is a phase I trial followed by a phase II randomized trial. The purpose of phase Istudy is the feasibility of treating patients with acute respiratory distress syndrome(ARDS) related to COVID-19 infection (COVID-19) with cord blood-derived mesenchymal stemcells (MSC). The purpose of the phase II trial is to compare the effect of MSC withstandard of care in these patients. MSCs are a type of stem cells that can be taken fromumbilical cord blood and grown into many different cell types that can be used to treatcancer and other diseases. The MSCs being used for infusion in this trial are collectedfrom healthy, unrelated donors and are stored and grown in a laboratory. Giving MSCinfusions may help control the symptoms of COVID-19 related ARDS.

Chinese University of Hong Kong

Lung Function, Exercise Capacity, and Serology Responses in Patients With COVID-19

Conditions: Lung Function, Exercise Capacity, Quality of Life, COVID19

(a) Objectives 1. To assess the full lung function, exercise capacity, quality of life in patients with COVID-19 over 2 years. 2. To assess the longevity of the serology response to SARS-CoV2. 3. To investigate the association of the neutralization titer in plasma from different vaccinated cohorts to its protection of infection using in vivo model 4. To investigate the SARS-CoV-2 specific cellular and humoral immunities as well as their determinant factors from community subjects who have received different types of COVID-19 vaccines. 5. To assess the third booster dose for subjects who have poor antibody response despite having received two doses of CoronaVac (Sinovac)

Haukeland University Hospital

Comparison of the Immune Response to Natural COVID-19 Infection and Vaccination

Conditions: COVID19

The ongoing Coronavirus Disease 2019 (COVID-19) pandemic has been intensified by nopopulation-based immunity to the severe acute respiratory disease coronavirus 2(SARS-CoV2) and initially lack of effective treatments or vaccines available to mitigatethe pandemic. Currently, two COVID-19 vaccines are available for vaccination in Europethrough conditional marketing authorisation granted by the European Medicines Agency andfurther vaccine will be licensed. These vaccines have shown good vaccine efficacy inphase 3 vaccine trials. We will recruit subjects who will be prioritised for vaccinationwith the primary aim of comparing the immune responses after COVID-19 vaccination andnatural SARS-CoV-2 infection. In Western Norway we have recruited cohorts of health careworkers and patients infected with SARS-CoV-2 and will extend to COVID-19 vaccinees.Demographic, clinical data and repeated blood samples will be collected to evaluate thecomplications and kinetics, duration and breadth of the immune responses comparingnatural infection to vaccination.

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Status

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Intervention Type

  • (-) Biological (14)
  • Other (5)
  • Drug (3)

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© Reagan-Udall Foundation for the FDA