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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 110 of 134

ClinAmygate

Timing of Corticosteroids in COVID-19, II. Post COVID-19 Follow-up

Conditions: COVID19, Corticosteroids

Timing of of corticosteroids administration is very important in COVID19 cases for therecovery and decrease the mortality.

Case Western Reserve University

S-Nitrosylation Therapy of COVID-19

Conditions: SARS-CoV2 Infection, COVID19

The primary objective of this study is to provide expanded access of S-nitrosylationtherapy for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2)infection.

ClinAmygate

Anosmia and / or Ageusia and Early Corticosteroid Use

Conditions: COVID19, Anosmia

Time to recover of Anosmia and / or ageusia and early corticosteroid use

Nature Cell Co. Ltd.

Study to Evaluate the Efficacy and Safety of AstroStem-V in Treatment of COVID-19 Pneumonia

Conditions: COVID19 Pneumonia

This study is an open-label, single-arm study to evaluate the safety and efficacy ofAstrostem-V, allogenic adipose tissue derived mesenchymal stem cells (AdMSC), in patientswith COVID-19 pneumonia. After each subject completes 12-Weeks visit (Visit 12) and thedata management team confirms all individual data have no issue, the individual databasewill be locked and the blinding will be open for the statistical analysis.

Karolinska Institutet

Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma

Conditions: Multiple Myeloma

Prospective, single center, randomized, open label, parallel group, 2-arm study assessingthe clinical benefit in term of enhancement of overall response rate of Isatuximab incombination with CellProtect as compared to Isatuximab for the treatment of patients withnewly diagnosed multiple myeloma who are eligible for stem cell transplantation (SCT) asmaintenance after SCT.

Australian National University

Nebulised Heparin in Patients With Severe COVID-19

Conditions: COVID19, Respiratory Failure

The Can nebulised HepArin Reduce morTality and time to Extubation in Patients withCOVID-19 Requiring mechanical ventilation Meta-Trial (CHARTER-MT) is a prospectivecollaborative individual patient data analysis of randomised controlled trials and earlyphase studies. Individual studies are being conducted in multiple countries, includingAustralia, Ireland, the USA, and the UK.Mechanically ventilated patients with confirmed or strongly suspected SARS-CoV-2infection, hypoxaemia and an acute pulmonary opacity in at least one lung quadrant onchest X-ray, will be randomised to nebulised heparin 25,000 Units every 6 hours orstandard care (open label studies) or placebo (blinded placebo controlled studies) for upto 10 days while mechanically ventilated. All trials will collect a minimum core dataset.The primary outcome for the meta-trial is ventilator-free days during the first 28 days,defined as being alive and free from mechanical ventilation. Individual studies may haveadditional outcomes.

Dr. Negrin University Hospital

Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions

Conditions: Acute Hypoxemic Respiratory Failure

Background: There are no proven therapies specific for pulmonary dysfunction in patientswith acute hypoxemic respiratory failure (AHRF) caused by infections (includingCovid-19). The full spectrum of AHRF ranges from mild respiratory tract illness to severepneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. Theefficacy of corticosteroids in AHRF and ARDS caused by infections remains controversial.Methods: This is a multicenter, randomized, controlled, open-label clinical trial testingdexamethasone in mechanically ventilated adult patients with established AHRF (includingARDS) caused by confirmed pulmonary or systemic infections, admitted in a network ofSpanish ICUs. Eligible patients will be randomly assigned to receive dexamethasone:either 6 mg/d x 10 days or 20 mg/d x 5 days followed by 10 mg/d x 5 days. The primaryoutcome is 60-day mortality. The secondary outcome is the number of ventilator-free daysat 28 days. All analyses will be done according to the intention-to-treat principle.

Boehringer Ingelheim

Nintedanib for the Treatment of SARS-Cov-2 Induced Pulmonary Fibrosis

Conditions: SARS-Cov-2 Induced Pulmonary Fibrosis

Currently, there is no approved treatment for COVID-19 in France, either for the acutephase, nor for the late chronic phase. the investigator suggest that nintedanib has thepotential to block the development of lung fibrosis when initiated early enough toinhibit the activation of mesenchymal cells and the progression of virus-inducedpulmonary fibrosis. Computerized Tomography (CT) manifestations of fibrosis or fibrousstripes are described in COVID-19 (Ye, Eur Radiol 2020). Pan et al observed fibrousstripes in 17% patients in the early phase of the disease (Pan, Eur Radiol 2020). Ye etal observed bronchiectasis in 2 patients (15.4%) and evidence of pulmonary fibrosis in 3patients (23.7%) at HRCT performed at 4 weeks (Ye, Eur Radiol 2020). Long term data arestill lacking in patients with COVID-19 and the investigators do not know how manypatients will have fibrotic sequelae from the acute illness.

CMN "20 de Noviembre"

Estrogen Therapy in Non-severe COVID-19 Patients

Conditions: COVID-19

The primary objective of this study is to evaluate the effect of additional estradiolestrogen therapy on clinical response and mortality in non-severe COVID-19 patients

Institut de Recherches Cliniques de Montreal

Study of Isoquercetin (IQC-950AN) Plus Standard of Care Versus Standard of Care Only for the Treatment of COVID-19

Conditions: COVID-19

This is an open-label, randomized, multi-centre study where hospitalized subjects will berandomized in a 2:1 ratio to receive Isoquercetin (IQC-950AN) in addition to standard ofcare or standard of care only for 28 days following confirmation of a COVID-19 infection.

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Status

  • Unknown status (64)
  • Active, not recruiting (37)
  • Recruiting (19)
  • Enrolling by invitation (5)
  • Not yet recruiting (4)
  • Available (3)
  • Approved for marketing (2)

Intervention Type

  • (-) Drug (134)
  • Other (17)
  • Biological (11)
  • Dietary Supplement (4)
  • Combination Product (3)
  • Device (1)
  • Procedure (1)
  • Radiation (1)

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