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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 120 of 254

University of Toronto

The Açaí Berry COVID-19 Anti-Inflammation Trial

Conditions: COVID

The Açaí trial will be testing if the açaí berry extract, a safe natural product withanti-inflammatory properties, can be used as a treatment option in adult patients withCOVID-19 in the community.

Boston Children's Hospital

Pulmozyme to Improve COVID-19 ARDS Outcomes

Conditions: COVID

This is a randomized double-blind placebo-controlled Phase II trial of recombinant humandeoxyribonuclease I (rhDNase I) - Pulmozyme - in mechanically ventilated patients withCOVID-19 pneumonia.Patients admitted to the ICU with severe COVID-19 pneumonia who require mechanicalventilation will be invited to participate in this study. Potential subjects will beidentified from medical record review or from direct contact with physicians.Investigators will check medical history and confirm eligibility. Informed consent willbe obtained from either the patient or designated healthcare proxy.60 subjects will be enrolled. After obtaining informed consent, patients will berandomized 2:1 to Pulmozyme 2.5 mg BID for up to 28 days or until they are no longerreceiving mechanical ventilation, whichever is sooner plus standard of care vs. placebonormal saline 2.5 ml plus standard of care.

E-MO Biology Inc

Polio Vaccine (IPV) for SARS-CoV-2 and Prevention of Coronavirus Disease (COVID-19)

Conditions: SARS-CoV-2

A total of 300 healthy volunteers between the ages of 18 and 80 with no previous historyof COVID-19 will be entered into the study and will receive IPV by injection on Day 1.Blood specimens collected pre-inoculation will be tested for cross-reactivity topoliovirus and SARS-CoV-2 by Western blot. An additional specimen will be collected onDay 28 post-inoculation and, likewise tested for cross-reactivity to poliovirus andSARS-CoV-2.The number of subjects with an immune response to SARS-CoV-2 antigens followinginoculation with IPV will be summarized.

Fondazione Epatocentro Ticino

Methylene Blue Treatment of COVID-19

Conditions: SARS-COV2

Despite enormous progress in understanding COVID-19, there is little evidence that asolution, therapeutic or preventive, is close to being achieved. Repurposing of wellknown, widely available drugs represent an attractive approach to speed up availabilityof active treatments. Such substances as i.e. hydroxychloroquine and others, are alreadyunder investigation and in widespread off label use. For many reasons Methylene blue(MB), the oldest synthetic substance in medicine (1876 synthesized by BASF) is such apromising candidate for an active treatment against SARS-CoV-2 infected people and forCOVID-19 patients.

Jiangsu Province Centers for Disease Control and Prevention

Phase I Trial of a Recombinant COVID-19 Vaccine (CHO Cell)

Conditions: COVID-19

This is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safetyand immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthypopulation aged 18 years and older. After randomization, the trial for each subject willlast for approximately 13 months. Screening period is 1 week prior to randomization (Day-7 to Day -1), and each dose of either SARS-CoV-2 vaccine (CHO Cell) or placebo will begiven intramuscularly (IM) on Day 0 and Day 14 for a two-dose regimen, or on Day 0, Day14, and Day 28 for a three-dose regimen. Subjects who are ≥18 years old and ≤ 59 yearsold will be enrolled in adult group, and healthy elderly population who are >59 years oldwill be enrolled in elderly group. After adult group completes the follow-up 7 days afterfirst vaccination, elderly group will be recruited.

Lebanese American University Medical Center

Managing Endothelial Dysfunction in COVID-19 : A Randomized Controlled Trial at LAUMC

Conditions: COVID19

COVID-19 infection was shown to cause endothelial dysfunction .At the level of the endothelium the pathophysiological mechanisms have been hypothesizedand were divided into pro-coagulant, pro-inflammatory, anti-fibrinolytics, impairedbarrier function, vasoconstrictor and pro-oxidant. So far, the pro-coagulant andpro-inflammatory pathways have been studied and as a result dexamethasone andanticoagulation became part of the standard therapies for the disease. However, so far,no RCT has been evaluated on targeting the vasoconstrictive and antioxidant pathways withan aim of revealing clinical benefit.So, with this trial we intend to provide a regiment composed of several medications wehypothesize will act on several downstream pathways that would improve endothelialfunction primarily via the increase in NO production and release.At the time of this proposal there has been no randomized trials evaluating or testingthe use of cardiovascular drugs targeting endothelial dysfunction in COVID-19 patients.As previously noted there has been a call to study these drugs and their effect after astrong research regarding their theorized effectiveness. For evidence, there was arecently published meta-analysis evaluating the role of statins in COVID-19 withpreliminary findings suggested a reduction in fatal or severe disease by 30% anddiscredited the suggestion of harm, that emphasized on the need of well-designedrandomized controlled trial to confirm the role of statins in COVID-19 patients.Our study would help determine the potential therapeutic effect of the endothelialprotocol as adjunct to mainstream management. This study seeks to further our knowledgein treating COVID-19 to ultimately improve clinical outcomes and reduce complications.

Hellenic Cooperative Oncology Group

Head and Neck cancERs International cOviD-19 collabOraTion

Conditions: Head and Neck Cancer, COVID19

To develop an International registry on head and neck cancer patients infected withCOVID-19

Assiut University

CMR Findings in COVID-19 Patients Presenting With Myocardial Infarction

Conditions: Myocardial Infarction

To compare myocardial injury in COVID 19 patients presented with myocardial infarctionand non COVID Patients presented with myocardial infarction evaluated with CMR

National Research Agency, France

Coagulopathy and Vasculopathy Assessment as a Predictor of the Severity of SARS-CoV-2 / COVID-19 Infection

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

On 30 January 2020, WHO declared the SARS-CoV-2 outbreak as a public health emergency ofinternational concern. Compared to SARS-CoV, which caused an outbreak of SARS in 2003,SARS-CoV-2 has a higher transmission capacity. Although the clinical manifestations ofSARS-CoV-2 are dominated by respiratory symptoms, some patients have severecardiovascular damage. In addition, patients with underlying cardiovascular disease maybe at increased risk of death. Therefore, understanding the impairments caused bySARS-CoV-2 to the cardiovascular system and the underlying mechanisms is of the utmostimportance.Circulating endothelial cells (CECs) are generally considered markers of lesions and maybe non-invasive markers of pulmonary vascular dysfunction during SARS-CoV-2 infection.Another marker of endothelial activation could be circulating extracellular vesicles.They could also be involved in the spread of the virus. Thus this project proposes tostudy different aspects of the diagnosis and pathophysiology of SARS-CoV-2. We propose tofully study activation state of coagulation and endothelium on a plasma and cellular sidein patients diagnosed with SARS-CoV-2/COVID19. The different forms of the disease will beincluded: without lung disease, with a more or less severe lung disease, i.e. havingevolved or not towards acute respiratory distress syndrome (ARDS). Extensive research ofbiomarkers will be compared to the detection of the virus in the respiratory tract aswell as in the blood. This work will contribute to a better description of diseasepathophysiology and should allow us to identify a patient profile in whom preventive orcurative anticoagulant therapy could be considered.

AB Science

Masitinib Combined With Isoquercetin and Best Supportive Care in Hospitalized Patients With Moderate and Severe COVID-19

Conditions: SARS-CoV 2, COVID-19, Coronavirus Disease 2019

Study objective is to evaluate the efficacy of the combination of masitinib andisoquercetin in adult hospitalized patients with moderate and severe 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)
  • Dietary Supplement (4)
  • Radiation (3)

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