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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 80 of 254

InCor Heart Institute

Mechanical Ventilation Strategy for Coronavirus Disease 2019 (COVID-19)

Conditions: Respiratory Distress Syndrome, Mechanical Ventilation, SARS (Severe Acute Respiratory Syndrome)

This is a prospective, randomized, single-center, open-label controlled trial, designedto compare the efficacy of two ventilation strategies (Low Tidal Volume and positiveend-expiratory pressure (PEEP) based on the Acute Respiratory Distress Syndrome (ARDS)Network low PEEP-fraction of inspired oxygen inspired oxygen fraction (FIO2) Table versusLow Driving Pressure and PEEP guided by Electrical Impedance Tomography (EIT) in reducingdaily lung injury score in patients with acute respiratory distress syndrome caused byCOVID-19. The two strategies incorporate different prioritizations of clinical variables.The PEEP-FIO2 table strategy aims to reduce lung overdistension, even if it requirestolerating worse gas exchange. EIT-guided strategy prioritizes mechanical stressprotection, avoiding alveolar overdistension and collapse.

Surgical Systems Research Group

Western Kenya Integrated COVID-19 Response

Conditions: COVID19

To respond to the COVID-19 pandemic, investigators will be deploying community healthworkers, equipped with mobile technology, and accompanied by youth to visit householdsdoor to door to screen for symptoms of COVID-19, isolate, test, and manage suspectedcases of COVID-19. The community health workers and youth will educate households aboutpreventive measures including frequent handwashing and home management of mild cases.Simultaneously, investigators will work with nurses, doctors, and clinical officers, totest and treat more severe cases of COVID-19 in health facilities. Our goals are: tovisit every household in Siaya county covering a population of close to 1 million, and totrain and support health workers working in 32 health facilities with oxygen capacity inSiaya to reduce the morbidity and mortality related to COVID19 and other conditions.

University of Roma La Sapienza

Sex-Informed Data in the COVID-19 Pandemic.

Conditions: COVID19

Sex and gender matter to health equity, especially in a pandemic. Sex (a biologicalattribute) and gender (a social construct) may influence an individual's susceptibility,vulnerability and exposure to infectious disease. In previous coronavirus epidemics (SARSand MERS), male sex was associated with worse outcomes. Both immune and the hemostaticresponse display ample sexual dimorphism.The primary aim of the study is to determine whether sex differences in biomarkers ofplatelet and immune function, gut microbiome, clinical characteristics, therapy, clinicalcost sensitive outcomes (i.e. in-hospital transition of care, case severity, andmortality due to COVID-19) exist in patients affected by COVID-19.

Climate Foundation

Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients

Conditions: COVID19

At least 1 in 6 COVID-19 patients admitted to hospital to receive extra oxygen will dieof complications. In patients with COVID-19, invasive treatment such as mechanicalventilation (e.g. breathing with a machine) is associated with a 50% increased risk ofdeath. Invasive treatments use a lot of healthcare resources in intensive care units andmay lead to further deaths if patients do not have access to care.The investigators aim to improve outcomes for COVID-19 patients by implementinghyperbaric oxygen therapy (HBOT). HBOT allows patients to breathe 100% oxygen in aspecial chamber at a pressure higher than sea level. It is approved by Health Canada for14 conditions. HBOT is safe when administered by experienced teams.There are two main causes of death in severe COVID-19 respiratory infections: (i) adecreased diffusion of oxygen from the lungs to the blood and (ii) an increasedinflammatory response (also called a "cytokine storm"). HBOT leads to increased oxygenlevel in blood, has strong anti-inflammatory effects, and may destroy the virusresponsible for COVID-19 disease. The initial experience with HBOT and COVID-19 fromChina, France and the United States is promising in that it prevents further worsening ofthe condition and need for intensive care.The investigators propose to test the effectiveness of HBOT for COVID-19 patients who areadmitted to hospital to receive extra oxygen. Using the most rigorous and innovativeresearch methods, this Canadian-led international study will operate at 5 centers across3 countries (Canada: Ottawa, Toronto, Edmonton; Switzerland: Geneva; UK: Rugby/London).The investigators anticipate that when treated by HBOT, COVID-19 patients needing extraoxygen to breathe will see significant health improvements as well as a decrease incomplications, inflammation in the blood, need for invasive care, death, and cost ofcare.

University of Sao Paulo

Evaluation of Systemic and Oral Conditions of Pregnant Women and Their Babies, With Exposure to COVID-19 Infection

Conditions: Exposure During Pregnancy, Corona Virus Infection

This research aims to investigate the incidence, clinical condition, mode of transmissionand laboratory data of women and their babies, who were exposed to COVID-19 infectionduring pregnancy. This project will consist of 4 subprojects, being that Subprojects 1and 2, will be of the observational, longitudinal type of prospective Cohort; Subproject3 will be of prevalence; Subproject 4 will be case-control. Subproject 1- This study aimsto assess periodontal condition and quality of life before and after delivery of womenwith excess weight gain or not, with exposure to coronavirus-sars-cov2. Subproject 2-Identify the proteins differentially expressed in saliva associated with COVID-19infection during the 3rd trimester of pregnancy in obese and eutrophic patients.Subproject 3- Assess the prevalence of congenital syndrome in babies associated with thepresumed maternal infection with SARS-CoV-2. Subproject 4- Case-control study in whichnewborns are submitted to clinical examination, being a group with congenitalmalformations and their respective controls and an interview with the mother was carriedout.

Centre Chirurgical Marie Lannelongue

Predicting the Progression to Chronic Fibrosis of Lung Lesions Related to Covid-19 Infection From Chest CT Images

Conditions: CoV2 SARS Pneumonia

The main differences observed between SARSCoV-2 pneumonia and other epidemic viralpneumopathies (e.g., seasonal influenza) are the greater infectivity of SARSCoV-2, theclinical severity of the disease, particularly in young patients without co-morbidities,and the observation of radiological images related to significant parenchymal aggressionin a large number of patients.The lesions in the acute phase correspond essentially to bilateral ground glass opacitymore or less associated with condensations which would be markers of more severeinfections.The major scope of the lesions in the acute phase raises the question of whether or notthe scanning anomalies are completely resolved over time, and the possible impact on lungfunction. This risk of sequelae is very important to study given the large number ofpatients affected by SARSCoV-2, especially since these are often young patients whoappear to be "healthy".In the current context of the CoV-2 SARS pandemic, the improved quality and availabilityof diagnostic scanners provides a wealth of information on the semiology and progressionof lung disease with minimal exposure to ionizing radiation. A majority of hospitalizedpatients with SARSCoV-2 received a CT scan in the early phase of the disease. Indeed, theFrench Society of Radiology has recommended the performance of a CT scan withoutinjection in thin sections in case of suspicion or for confirmation of the diagnosis inpatients presenting initial or secondary clinical signs of severity and justifyinghospital management due to the initial lack of reagents for performing biological tests(RT-PCR) and the high sensitivity of the CT scan and its specificity in epidemic periods.The present study aims to study the kinetics of lung involvement in SARS CoV 2, to studythe predictive character of the chest CT scan performed at the patient's discharge on theexistence of radiological sequelae at 3 months but also at 1 year in order not tomisunderstand the constitution of late fibrosis after partial resolution of the CTimages. The investigatos will study the correlation between possible radiologicalabnormalities and the clinical presentation (patient symptoms and lung function). Therigorous follow-up of these patients will allow us to set up, if necessary, earlytreatment of the detected abnormalities (inhaled corticoids in case of bronchial orbronchiolar damage, study of the place of an anti-fibrosis treatment in case offibrosis,...).

TMC HealthCare

Investigation of Antibody and Immune Responses to SARS-CoV-2 Proteins in COVID-19 Patients

Conditions: COVID-19, SARS-CoV-2 Infection

SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has negativelyimpacted global health and requires more research to develop better tests and to improvedisease treatment.The purpose of this research is to aid in the testing effort by collecting samples frompeople who have been diagnosed with COVID-19 or are suspected of having COVID-19. Samplesyou provide will be used investigationally by INanoBio to develop a test to determinewhen antibodies against various SARS-CoV-2 proteins are detectable.Up to approximately 80 subjects of all ages with either a suspected or lab-confirmeddiagnosis of COVID-19 will take part in this research.

INSERM, Epopé team

Covid-19 in Pregnancy: a French Population-based Cohort of Women and Newborns

Conditions: COVID19 Infection, Pregnancy Complications, Neonatal Complications

The purpose of this study is to characterize the incidence and clinical features of thematernal COVID 19 infection, as well as the associated morbidity of the mother and thechild, in the French context

University of California, Los Angeles

Covid-19 Convalescent Plasma as Prevention and Treatment for Children With Underlying Medical Conditions

Conditions: Corona Virus Infection

This study will provide access to investigational anti-SARS-CoV-2 human convalescentplasma for pediatric patients with underlying medical conditions (cardiovascular disease,lung disease, immunosuppression) who are either infected with SARS-CoV-2 or who have hada high-risk exposure. Study participants will be transfused once with compatibleconvalescent plasma obtained from an individual who has recovered from documentedinfection with SARS-CoV-2. Safety information and pharmacokinetic data will be collected.

Chelsea and Westminster NHS Foundation Trust

PHenotyping patiENts Admitted to Hospital With cOvid-19 Infection and idenTifYing Prognostic markErs

Conditions: Coronavirus, Corona Virus Infection, COVID-19, 2019nCoV, 2019 Novel Coronavirus Infection

PHENOTYPE is an investigator-led, observational cohort study which aims to explore thelong-term outcomes of patients with COVID-19 infection and to identify potential riskfactors and biomarkers that can prognosticate disease severity and trajectory.

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Status

  • (-) Unknown status (254)

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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