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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 60 of 530

Hasselt University

Changes in Cardiac and Pulmonary Hemodynamics as Predictor of Outcome in Hospitalized COVID-19 Patients

Conditions: COVID-19

The primary objective of the study is to evaluate cardiac and pulmonary hemodynamicchanges over time as predictor of disease progression and outcome in COVID-19 patientsadmitted to ICU.The primary endpoint is the occurrence of a major event predefined as either: death(all-cause mortality) or discharge from ICU (limit of 4 months).This is a uni-center prospective observational cohort study with an inclusion period of 2months. The end of the study is foreseen in 6 months.

Fundacion Miguel Servet

Outcomes of Covid-19 Protective Measures in Endoscopy

Conditions: COVID-19 Disease, Endoscopy Unit

Prospective study evaluating the outcomes of implementation of a protective protocol forCovid-19 for patients and staff in a large endoscopy unit.

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.

Jessa Hospital

Minimal Invasive Autopsies to Investigate Changes in Deceased COVID-19 Patients

Conditions: COVID-19

Rationale In a very short time corona virus disease 2019 (COVID-19) has become a pandemicwith high morbidity and mortality. The main cause of death is respiratory failureincluding acute respiratory distress syndrome, however the exact mechanisms and otherunderlying pathology is currently not yet known. In the current setting of the COVID-19pandemic complete autopsies seem too risky due to the risk of SARS CoV-2 transmission.Yet, as so little is known, additional histopathological, microbiological and virologicstudy of tissue of deceased COVID-19 patients will provide important clinical andpathophysiological information. Minimal invasive autopsy combined with postmortem imagingseems therefore an optimal method combining safety on the one hand yet provingsignificant information on the other.This study aims to determine the cause of death and attributable conditions in deceasedCOVID-19 patients. This will be performed using post-mortem CT-scanning plus CT-guidedMIA to obtain tissue for further histological, microbiological and pathologicaldiagnostics. In addition, the pathophysiology of COVID-19 will be examined by furthertissue analysis.

Duke University

Duke COVID-19 Shared Data and Specimen Repository

Conditions: COVID-19

The purpose of this data repository is to provide a secure and centralized storagelocation and resource for the collection of essential data and medical specimens, acrossCOVID-19 related protocols at Duke.

Centre Hospitalier Universitaire, Amiens

COVID-19 Infection in Patients With Hepatocellular Carcinoma

Conditions: HepatoCellular Carcinoma, COVID-19

Since December 2019, a new disease named COVID-19 linked to a new coronavirus, SARS-CoV2has emerged in China in the city of Wuhan, Hubei province, spreading very quickly to all5 continents, and responsible for a pandemic. France is the third most affected countryin Europe after Italy and Spain. Groups of patients at a higher risk of developing asevere form of COVID-19 have been defined: this include patients with immunosuppressivedisease as cancer or patients with advanced cirrhosis of the liver. Coronavirus liverinjury had been described with SARS-CoV 1 and MERS-CoV. There is no data on liver damageassociated with COVID-19 infection for compensated or decompensated cirrhotic patients.The objectives of this project are to estimate the incidence of COVID-19 inhepatocellular carcinoma population, both hospital and ambulatory, and to study theimpact on the frequency of severe forms, the prognosis, but also liver function, and themanagement of hepatocellular carcinoma, in this context of pandemic

Johan Normark

Host-pathogen Interactions, Immune Response, and Clinical Prognosis at COVID-19 - the CoVUm Trial

Conditions: COVID-19

The project aims to clarify how immunity to SARS-CoV2 develops in humans and toinvestigate the possibility of finding patients with a particularly effective,neutralizing antibody response for future treatment. The project also aims to detail thevirus's damage mechanisms in tissue.

Healios K.K.

MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)

Conditions: ARDS

Multicenter investigation featuring an open-label lead-in followed by a double blinded,randomized, placebo-controlled Phase 2/3 part to evaluate the safety and efficacy ofMultiStem therapy in subjects with moderate to severe Acute Respiratory Distress Syndrome(ARDS) due to pathogens including COVID-19.

Maastricht University Medical Center

European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID-19 Patients in ECMO

Conditions: COVID, SARS-CoV-2, ARDS, Human, Refractory Hypoxemia, Cardiogenic Shock, Septic Shock, Extracorporeal Membrane Oxygenation

In the last 10 years, severe acute respiratory infection (SARI) was responsible ofmultiple outbreaks putting a strain on the public health worldwide. Indeed, SARI had arelevant role in the development of pandemic and epidemic with terrible consequences suchas the 2009 H1N1 pandemic which led to more than 200.000 respiratory deaths globally.In late December 2019, in Wuhan, Hubei, China, a new respiratory syndrome emerged withclinical signs of viral pneumonia and person-to-person transmission. Tests showed theappearance of a novel coronavirus, namely the 2019 novel coronavirus (COVID-19). Twoother strains, the severe acute respiratory syndrome coronavirus (SARS-CoV) and MiddleEast respiratory syndrome coronavirus (MERS-CoV) have caused severe respiratoryillnesses, sometimes fatal. In particular, the mortality rate associated with SARS-CoVand MERS-CoV, was of 10% and 37% respectively.Even though COVID-19 appeared from the first time in China, quickly it spread worldwideand cases have been described in other countries such as Thailand, Japan, South Korea,Germany, Italy, France, Iran, USA and many other countries. An early paper reported 41patients with laboratory-confirmed COVID-19 infection in Wuhan. The median age of thepatients was 49 years and mostly men (73%). Among those, 32% were admitted to the ICUbecause of the severe hypoxemia. The most associated comorbidities were diabetes (20%),hypertension (15%), and cardiovascular diseases (15%). On admission, 98% of the patientshad bilateral multiple lobular and sub-segmental areas of consolidation. Importantly,acute respiratory distress syndrome (ARDS) developed in 29% of the patients, while acutecardiac injury in 12%, and secondary infection in 10%. Invasive mechanical ventilationwas required in 10% of those patients, and two of these patients (5%) had refractoryhypoxemia and received extracorporeal membrane oxygenation (ECMO). In a laterretrospective report by Wang and collaborators, clinical characteristics of 138 patientswith COVID-19 infection were described. ICU admission was required in 26.1% of thepatients for acute respiratory distress syndrome (61.1%), arrhythmia (44.4%), and shock(30.6%). ECMO support was needed in 11% of the patients admitted to the ICU. During theperiod of follow-up, overall mortality was 4.3%.The use of ECMO in COVID-19 infection is increasing due to the high transmission rate ofthe infection and the respiratory-related mortality.Therefore, the investigators believe that ECMO in case of severe interstitial pneumoniacaused by COVID could represent a valid solution in order to avoid lung injuries relatedto prolonged treatment with non-invasive and invasive mechanical ventilation. Inaddition, ECMO could have a role for the systemic complications such as septic andcardiogenic shock as well myocarditis scenarios. Potential clinical effects and outcomesof the ECMO support in the novel coronavirus pandemic will be recorded and analyzed inour project.The researchers hypothesize that a significant percentage of patients with COVID-19infection will require the utilize of ECMO for refactory hypoxemia, cardiogenic shock orseptic shock. This study seeks to prove this hypothesis by conducting an observationalretrospective/prospective study of patients in the ICU who underwent ECMO support anddescribe clinical features, severity of pulmonary dysfunction and risk factors ofCOVID-patients who need ECMO support, the incidence of ECMO use, ECMO technicalcharacteristics, duration of ECMO, complications and outcomes of COVID-patients requiringECMO support.

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.

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Status

  • Unknown status (254)
  • Recruiting (129)
  • Active, not recruiting (116)
  • Enrolling by invitation (14)
  • Not yet recruiting (11)
  • Approved for marketing (3)
  • Available (3)

Intervention Type

  • Other (159)
  • Drug (134)
  • Biological (75)
  • Diagnostic Test (51)
  • Behavioral (24)
  • Device (16)
  • Procedure (11)
  • Dietary Supplement (8)
  • Radiation (7)
  • Combination Product (5)
  • Genetic (1)

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© Reagan-Udall Foundation for the FDA