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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 40 of 116

Institute of Progressive Medicine

Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals

Conditions: COVID19

Preliminary reports have been received from several sources that the periodic inhaling ofthe nebulized mist from water that has a heightened level of kinetic activity has quickly(less than 2 days) lessened the severity of symptoms in Covid-19 infected patients. On atleast several occasions, a repeat PCR test performed several after inhaling a particularwater-based product was negative. There are no perceived adverse effects from inhalingthe water mist by using a nebulizer or humidifier. It is important, however, to validatethese preliminary findings and to include the inhaling of the mist from water, which doesnot have an elevated level of kinetic activity. This will be by performed in apatient-blinded manner by sequentially inhaling the two types of water over consecutive2-day periods with Covid-19 testing at the end of each of the two day periods.Participants will be randomized as to whether they are to inhale the mist from the testor the control water.

Centre Hospitalier Victor Dupouy

Pathogens Involved in Secondary Infections During Severe Forms of Covid-19 Pneumonia:

Conditions: COVID19, Ventilator Associated Pneumonia, Nosocomial Pneumonia

A Respiratory infection with the SARS-CoV2 virus is associated with a major risk of viralpneumonia that can lead to respiratory distress requiring resuscitation. In the mostsevere forms, it may require mechanical ventilation or even lead to an acute respiratorydistress syndrome with a particularly poor prognosis. The SARS-CoV2 is a single-strandedRNA virus of positive polarity and belongs to the beta genus of Coronaviruses. SARS-CoV2is responsible for the third epidemic in less than twenty years secondary to aCoronavirus (SARS-CoV then MERS-CoV) and if the mortality associated with it is lowerthan that of previous strains, notably MERS-CoV, its spread is considerably big. As aresult, the number of patients developing respiratory distress requiring invasivemechanical ventilation is high, with prolonged ventilation duration in these situations

University of Melbourne

Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial

Conditions: SARS-CoV-2 Infection (COVID-19)

An International Multi-Centre Randomised Adaptive Platform Clinical Trial to Assess theClinical, Virological and Immunological Outcomes in Patients with SARS-CoV-2 Infection(COVID-19).

Johns Hopkins University

Decitabine for Coronavirus (COVID-19) Pneumonia- Acute Respiratory Distress Syndrome (ARDS) Treatment: DART Trial

Conditions: COVID-19

This is a a randomized double blind placebo controlled Phase 2 trial with a 12 patientlead-in to evaluate safety, prior to full enrollment to an additional 28 patients (for atotal of 40 patients) to assess efficacy of decitabine in the treatment of critically illpatients with COVID-ARDS. The patients will be randomized in a 1:1 ratio to receivestandard of care plus Decitabine or standard of care plus saline based placebo. Theprimary objective is to determine safety and efficacy of decitabine for COVID-19 ARDSbased on clinical improvement on a 6-point clinical scale.

University of Chicago

Low-dose Tocilizumab Versus Standard of Care in Hospitalized Patients With COVID-19

Conditions: COVID-19

Tocilizumab is an effective treatment for severe coronavirus disease 2019 (Covid-19)pneumonia and related inflammation. Given limited global supplies, clarification of theoptimal tocilizumab dose is critical. We conducted an open-label, randomized, controlledtrial evaluating two different dose levels of tocilizumab in Covid-19 (40mg and 120mg).Randomization was stratified on remdesivir and corticosteroid at enrollment. The primaryoutcome was the time to recovery. The key secondary outcome was 28-day mortality.

University Hospital Southampton NHS Foundation Trust

SafeFit Trial: Virtual Clinics to Deliver Universal Interventions in People With Cancer

Conditions: Cancer, COVID

Trial Phase: Phase III: Interventional Trial: Virtual clinics to deliver universalinterventions to maintain and improve physical health, nutritional state andpsychological wellbeing in people with cancer who are following social distancingguidance: A COVID-19 targeted trial.Indication: Male or female participants, aged over 18 years old with suspicion orconfirmed diagnosis of cancer (does not require histological confirmation)Objective: To investigate the efficacy of remote multimodal universal interventionsdelivered via virtual clinics to improve physical function as measured by theEORTC-QLQ-C30.Secondary Objective:To investigate the efficacy of remote multimodal universal interventions delivered viavirtual clinics to improve emotional function, quality of life, participant activation(PAM), behaviour change and the effect it has on health economics (EQ-5D-5L).Exploratory Objective:Overall Survival and adherence to the intervention/advice using validated tools ordevelopment of a web-based toolkit.

Varian Medical Systems

Low-Dose Radiotherapy For Patients With SARS-COV-2 (COVID-19) Pneumonia

Conditions: COVID-19, SARS-COV2, Pneumonia

Low doses of radiation in the form of chest x-rays has been in the past to treat peoplewith pneumonia. This treatment was thought to reduce inflammation and was found to beeffective without side effects. However, it was an expensive treatment and was eventuallyreplaced with less expensive treatment options like penicillin.The COVID-19 virus has emerged recently, causing high rates of pneumonia in people. Theauthors believe that giving a small dose of radiation to the lungs may reduceinflammation and neutralize the pneumonia caused by COVID-19. For this study, the x-raygiven is called radiation therapy. Radiation therapy uses high-energy X-ray beams from alarge machine to target the lungs and reduce inflammation. Usually, it is given at muchhigher doses to treat cancers.The purpose of this study is to find out if adding a single treatment of low-dose x-raysto the lungs might reduce the amount of inflammation in the lungs from COVID-19infection, which could reduce the need for a ventilator or breathing tube.

Oslo University Hospital

"NORPLASMA" Covid-19 Convalescent Plasma Treatment Monitoring Study

Conditions: COVID

NORPLASMA COVID-19 includes both the production of convalescent plasma from approvedblood donors who have recovered from covid-19 (coronavirus disease 2019), and clinicalstudies to evaluate efficacy and safety of the treatment, as recommended by Europeanhealth authorities. Patients who receive convalescent plasma in a clinical setting willbe invited to participate in the monitoring study NORPLASMA MONITOR, where clinical dataabout safety and effect on clinical parameters including virus load and recovery timewill be collected and compared to european patients in a common database for the Europeancountries. The treated patients can be compared to a historical control group.

Instituto Materno Infantil Prof. Fernando Figueira

Northeast COVID-19 and Pregnancy Study Group

Conditions: COVID19, Coronavirus Infection, Pregnancy Disease, Severe Acute Respiratory Syndrome

A prospective and retrospective cohort study. The objective will to determine thefrequency of COVID-19 in pregnant and postpartum women hospitalized with flu syndrome, toevaluate clinical and laboratory predictors of COVID-19 progression and to determine thefactors associated with adverse maternal and perinatal outcomes in healthcare centers intwo states of Northeast Brazil.The study will be conducted including pregnant andpostpartum women with clinical or laboratorial diagnosis of COVID-19, admitted in sixhealthcare centers in the Northeast of Brazil. All pregnant and postpartum women withclinical and/or diagnosis of COVID-19, attended in prenatal care, in emergency (maternitytriage), high-risk pregnancy ward, obstetric intensive care unit and rooming-in ward willbe included. The data will be collected in specific forms. The exams will be carried outby trained professionals within each institution.

Sanofi

Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)

Conditions: Primary Progressive Multiple Sclerosis

Primary Objective:To determine the efficacy of SAR442168 compared to placebo in delaying disabilityprogression in primary progressive multiple sclerosis (PPMS)Secondary Objectives:To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magneticresonance imaging (MRI) lesions, cognitive performance, physical function, and quality oflife To evaluate safety and tolerability of SAR442168 To evaluate populationpharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety Toevaluate pharmacodynamics of SAR442168

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Status

  • (-) Active, not recruiting (116)

Intervention Type

  • Drug (37)
  • Other (27)
  • Biological (17)
  • Diagnostic Test (14)
  • Behavioral (5)
  • Procedure (5)
  • Device (2)
  • Dietary Supplement (2)
  • Radiation (2)

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