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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 30 of 254

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.

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.

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.

ONCO PAYS de la LOIRE

Impact of Confinement and Preventive Measures in Period of SARS-COV2 Infection on Clinical Features, Diagnostic and Therapeutic Management and Prognosis of Patients With Lung Cancer

Conditions: COVID, SARS-CoV 2, Lung Cancer

The unexpected onset of SARS-COV2 infection modified our practices, especially in routinemedicine. In order to reverse the epidemic curve of severe cases and slow the spread ofthe infection, confinement was generalized in France from March 13, 2020.Theserestrictive measures were imposed on anyone with symptoms compatible with the infection,with the exception of dyspnea and other criteria of severity. March 12, 2020 is thepivotal date when the management of COVID came to interfere with medical and healthcareorganizations. From this date, it is likely that some imaging or endoscopic exams havebeen de-scheduled for symptoms that are sometimes wrongly judged to be non-urgent andhave seen their numbers drop dramatically.Otherwise, concerning lung cancer, preventivemeasures have been extremely strengthened. For instance, it is recommended to delaysurgeries for localized tumors, to relieve or remove some chemotherapy or to deleteradiotherapy sessions deemed non-essential. However, symptoms that may initially beattributed to viral infection, such as cough, fever, fatigue, or chest pain may beclinical indicators of early-stage Lung cancer. In addition, lung cancer is likely tomake the patient more susceptible to pneumopathy, due to a weakened of immune response toviruses and bacteria. Consequently, as necessary as the restriction measures are, a riskof slowing down in the management of the Lung cancer pathology exists.The CBP-COVID Study intends to assess consequences of restrictive measures linked to theSARS-COV2 epidemic, by comparing clinical characteristics at diagnosis, treatment timesand treatments, regarding to 2 distinct time periods identical to the calendar, but onein 2019, the other in 2020.

Bristol-Myers Squibb

Safety and Efficacy of Therapeutic Anticoagulation on Clinical Outcomes in Hospitalized Patients With COVID-19

Conditions: Cardiovascular Diseases, COVID-19

The coronavirus disease 2019 (COVID-19) global pandemic caused by the severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2) has caused considerable morbidity andmortality in over 170 countries. Increasing age and burden of cardiovascularcomorbidities are associated with a worse prognosis among patients with COVID-19. Inaddition, serologic markers of more severe disease including coagulation abnormalitiesand thrombocytopenia, are not uncommon among patients hospitalized with severe COVID-19infection and are more common in patients who died in-hospital. As the COVID-19 pandemiccontinues to grow, there is a pressing need to identify safe, effective, and widelyavailable therapies that can be scaled and rapidly incorporated into clinical practice.Understanding the putative mechanism of increased mortality risk associated with abnormalcoagulation function and cardiac injury is critical to guide studies of promisingtherapeutic interventions. Published and anecdotal reports indicate that endothelialdysfunction and thrombosis are common in critically ill patients with COVID-19, includingreports of diffuse microvascular thrombosis in the lungs, heart, liver, and kidneys.Patients with cardiovascular disease (CVD) and CVD risk factors are known to haveendothelial dysfunction and a heightened risk of thrombosis. A recent study of COVID-19inpatients from Wuhan, China observed that an elevated D-dimer level greater than 1 ug/mLwas associated with an 18 times higher risk of in-hospital death, underscoring theimportance of increased coagulation activity as a potential modifiable risk marker thatmay drive end-organ injury. Given the established link between endothelial dysfunctionand thrombosis in patients with cardiovascular disease, and the association betweencoagulopathy and adverse outcomes in patients with sepsis, the association betweenincreased coagulation activity, end-organ injury, and mortality risk may represent amodifiable risk factor among COVID-19 patients with critical illness. Therefore, wepropose to conduct a randomized, open-label trial of therapeutic anticoagulation inCOVID-19 patients with an elevated D-dimer to evaluate the efficacy and safety.

Cambia Health Solutions

Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Adults With Polypharmacy Using Data From Large Medicare and Commercially Insured Populations

Conditions: COVID, Drug Effect, Drug Interaction, Adverse Drug Event

This retrospective study aims to perform a medication risk stratification using drugclaims data and to simulate the impact of the addition of various repurposed drugs on theMedication Risk Score (MRS) in a health insurance population. Our clinical tool wouldenable us to identify potential multi-drug interactions and potentially reduce the riskof adverse drug events (ADE) developing in these patients infected with COVID-19.

University Hospital Tuebingen

Mesenchymal Stem Cells (MSCs) in Inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS)

Conditions: ARDS, COVID-19

To evaluate the safety, toxicity and immunological effects of infusion of allogeneic bonemarrow-derived human mesenchymal stem (stromal) cells (MSCs) and whether this therapy hasan influence on the resolution processes in ARDS patients infected with Severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2).

University of California, Irvine

Harnessing Online Peer Education Online Support Intervention for COVID-19 (HOPE COVID-19)

Conditions: COVID-19 Vaccination

The Harnessing Online Peer Education COVID-19 (HOPE COVID-19) intervention will assesswhether a peer-led online support community can improve behavioral health outcomesrelated to COVID-19.

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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)
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  • Radiation (3)

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© Reagan-Udall Foundation for the FDA