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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 254

King's College London

COVID-19 Symptom Tracker

Conditions: COVID-19

The viral Covid-19 outbreak is now considered a pandemic according to the World HealthOrganisation (WHO). A free monitoring app 'COVID-19 Symptom Tracker' has been developedto record and monitor the symptoms of the COVID-19 coronavirus infection; tracking inreal time how the disease progresses. The app also records how measures aimed atcontrolling the pandemic including self-isolation and distancing are affecting the mentalhealth and well-being of participants. The data from the study will reveal importantinformation about the symptoms and progress of COVID-19 infection in different people,and why some go on to develop more severe or fatal disease while others have only mildsymptoms do not.

Target PharmaSolutions, Inc.

An Observational Study of Patients With Coronavirus Disease 2019

Conditions: COVID-19, Coronavirus

This is an observational study of patients with COVID-19 designed to specifically addressimportant clinical questions that remain incompletely answered for coronavirus disease2019.

Sunnybrook Health Sciences Centre

Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial

Conditions: COVID-19

This study is an adaptive, randomized, open-label, controlled clinical trial, incollaboration with countries around the world through the World Health Organization.

BioMérieux

COVID-19 - Study of the Kinetics of the Immune Response During the Intensive Care Unit Stay in Adult Patients Infected With SARS-CoV-2: Multicentric Non Interventional Study

Conditions: Intensive Care Unit, SARS-CoV-2

Infection with the SARS-CoV-2 coronavirus (COVID-19) has recently been identified as apandemic due to the speed and global scale of its transmission. In Auvergne-Rhône-Alpesregion (AURA), the epidemic began in February 2020 and the number of infected people isstill important. Between 15 and 20% of COVID-19 patients develop an acute respiratorydistress syndrome (ARDS) leading to their hospitalization in intensive care. Theirclinical progression can be rapidly harmful with the development of severe ARDSassociated with an increased risk of death.Preliminary data on the immune response of COVID-19 patients describe the induction of amoderate inflammatory response and the occurrence of major progressive lymphopenia overtime associated with potential immunosuppression. Up to 50% of secondary infections arereported in deceased COVID-19 patients. However, no prospective study has exhaustivelydescribed the kinetics of the immune response of COVID-19 patients in intensive care.The precise description of the immune response over time in adult patients with a proveninfection with the SARS-CoV-2 virus and the study of the relation between this responseand the increased risk of organ failure (severe ARDS), death or nosocomial infection willallow us to better understand the pathophysiology of the immune response induced byCOVID-19 in order to (i) identify new therapeutic strategies targeting the host responsein patients in intensive care (ii) to develop biological markers to stratify patients forfuture clinical trials evaluating these immunoadjuvant treatments in COVID-19.

Kaohsiung Kai-Suan Psychiatric Hospital

The Impact and Coping Strategy of COVID-19 Among Taiwan Society and Medical and Nursing Institutes

Conditions: The Psychological Impact of COVID-19

The Coronavirus disease 2019 (COVID-19) had its outbreak in late 2019 in China and isconsidered a biological disaster. With medical organizations and staff on the frontline,the investigators should conduct assessments, for the different tiers of medical staff,patients, and community residents, on the short- term psychological and mentaldisabilities or danger factors that they might have faced. As such, the investigators candesign and establish a set of evaluative indicators of the risks of biological disasters,and strategies to manage guide and cope, and internal/ external testing strategies. Thesework in guaranteeing quality and performance, and as such, establishing "Digital Platformfor Integrated Research of Coronavirus disease 2019 (COVID-19)".

McGill University

The Covid-19 Outpatient Symptom Montelukast Oximetry Trial

Conditions: COVID-19

Primary care physicians face limited availability of therapeutic options for thetreatment of COVID-19 in the outpatient setting. Furthermore, monoclonal antibodies andantiviral therapies that are currently approved for use in the outpatient setting byHealth Canada have excluded pregnant women and older adults from their clinical trials,are contraindicated for many patients, and most are prohibited for use by pregnant women.Identification of a safe, COVID-19 outpatient therapeutic with 20-year safety recordremains urgently needed.

Centre Hospitalier Intercommunal Creteil

Covid-19 Pediatric Observatory

Conditions: COVID-19

In early December 2019, cases of pneumonia of unknown origin were reported in Wuhan,Hubei Province in the People's Republic of China. The disease spreads rapidly and thenumber of sick people is increasing. On January 3, 2020 a new virus of the coronavirusfamily is identified in samples of bronchoalveolar lavage fluid from a patient in Wuhanand subsequently confirmed as the cause of these pneumonias. On 7 January 2020, the WorldHealth Organization (WHO) designated it as the new coronavirus 2019 (i.e. 2019-nCoV). On11 February 2020, the WHO designated the disease associated with 2019-nCoV as coronavirus2019 disease (COVID-19). On 12 March, WHO announced that the COVID-19 outbreak is apandemic.As of March 24, 2020, more than 375,000 cases of COVID-19 had been diagnosed with morethan 16,000 deaths attributed to this virus. (Ref WHOhttps://www.who.int/emergencies/diseases/novel-coronavirus-2019 ).In France, the number of cases rose from 105 cases at the end of February to 19615confirmed cases on March 24. (Source Public Health France). Most of the cases are adults.However, children are not completely spared and serious cases have been described. Thesesevere cases can be respiratory or extra-respiratory (e.g. myocarditis). We also knowthat pediatric and adult cases differ in terms of clinical, biological and imagingfindings, particularly chest CT scans. However, the description of paediatric pictures,especially severe forms and the involvement of children suffering from co-morbidities,remains poorly reported. Finally, the risk factors for serious cases in children remainlargely unknown.This observatory aim to describe the clinical phenotypes of hospitalized pediatricpatients with Covid19 in France, according to age groups. Moreover for a subgroup ofpatients, informations regarding the long covid will be reported.

Ola Blennow, MD, PhD

Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)

Conditions: COVID-19, Pneumonia, Viral, SARS-COV2

Randomized open label clinical trial carried out at study centers in Sweden, includingKarolinska University Hospital, S:t Göran Hospital, Danderyd Hospital and VästmanlandsHospital. Patients with COVID-19 who are hospitalized with oxygen therapy are eligiblefor inclusion. Subjects are randomized to 14 days of inhalation with ciclesonide 360 µgtwice daily or to standard of care. Primary outcome is duration of received supplementaloxygen therapy. Key secondary outcome is a composite outcome of death and receivedinvasive mechanical ventilation within 30 days.

Centre Hospitalier Universitaire de la Réunion

HDL Target of CoViD19 ? Analysis on the Caregivers of the Reunion University Hospital

Conditions: SARS-CoV Infection

Since December 2019, the Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2)pandemic has spread around the world. The people most exposed to this virus remain thehealthcare personnel who are on the front line in the fight against this pandemic. Due tothe delayed nature of the pandemic in Reunion island and its insular geographicalsituation, the study of the voluntary medical personnel will allow the investigators toestablish a longitudinal follow-up of the anomalies of the lipidic balance in relation tothe exposure to the SARS-Cov virus. 2. During bacterial infections, the lipid profilesare profoundly modified with very significant reductions in plasma cholesterol levels,LDL-C but especially HDL-C whose concentrations are particularly low. Lipid profiles arealtered during viral infections, for example, the severity of dengue is inverselycorrelated with total cholesterol and LDL-C but not with HDL-C levels, according to arecent meta-analysis. The hepatitis C virus circulates in serum linked to lipoproteinsrich in triglycerides and HDL can facilitate its entry into cells via Scavenger receptorclass B type 1 (SRB1). Likewise, it has been shown that apoA1 can bind to the denguevirus and increase its infectivity by promoting its entry into cells, also via SRB1. Atthe moment, nothing is known about the lipid profiles in subjects with SARS-CoV-2. Theinvestigator hypothesize that a drop in plasma HDL-C levels and a change in their sizeduring infection could justify future therapeutic approaches aimed at supplementing thesubjects most at risk of pulmonary complications. In a model of Pseudomonas aeruginosapneumonia in mice, investigators have shown that the injection of reconstituted HDLallowed to limit the pulmonary inflammation and the deleterious consequences of theinfection. The investigator propose to study not only the lipid profiles in subjects whoare infected with SARS-CoV-2 but also the polymorphisms of genes involved in theregulation of lipoprotein levels like that of Cholesterol Ester-Transfer Protein (CETP)depending on the developed forms, symptomatic or not.

European Leukemia Net

Myeloproliferative Neoplasms (MPN) and COVID-19

Conditions: Myeloproliferative Neoplasm, COVID

An increased risk of both venous and arterial thromboembolism was noted in reports fromSARS-CoV-2-infected patients in China and has been confirmed in autopsy findings frompatients who experienced sudden death. Myeloproliferative Neoplasms (MPNs), whichencompass polycythemia vera, essential thrombocythemia and primary myelofibrosis, arethrombophilic disorders with a natural propensity to thrombosis that is fuelled by theintrinsic activation of inflammatory cytokines. It therefore follows that an underlyingdiagnosis of MPN may increase the risk of worse clinical outcomes and death duringperiods of active Covid-19 disease. This ambispective, observational study aims toelucidate the key factors which affect the clinical course of patients with MPN whodevelop Covid-19 disease.

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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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