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Home
  • About
      1. Board of Directors
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      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 500 of 530

Walvax Biotechnology Co., Ltd.

Phase II Clinical Trial of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19

Conditions: COVID-19

The purpose of this double-blind, randomized, controlled study is to assessimmunogenicity and safety of 202-CoV at multiple dose levels, administered as 2injections (i.m) at 28 days apart in adult subjects 18 years of age and above.

ResApp Health Limited

Cough Sound Recordings to Understand COVID-19-like Symptom Progression to Understand COVID-19-like Symptom Progression

Conditions: COVID19

Decentralized clinical study designed to collect further cough sounds, self-reportedsymptoms, and medical treatment questionnaires from participants enrolled on theCOVID-Cough Study ("Study 1").The aim of this further data collection study ("Study 2") is to: 1. develop an understanding of changes in cough sounds associated with COVID-19 and how they alter during the disease; 2. develop an understanding of other causes of COVID-19-like symptoms and their associated cough sound patterns; and 3. gain a broader understanding of the clinical outcomes of individuals who present for COVID-19 testing.

Mahmoud Ramadan mohamed Elkazzaz

CRISPR/Cas9-modified Human T Cell ( PD-1and ACE2 Knockout Engineered T Cells ) for Inducing Long-term Immunity in COVID-19 Patients

Conditions: COVID-19 Respiratory Infection

T-cell exhaustion may limit long-term immunity in COVID-19 patients. T cells can losetheir ability to fight viruses and tumors when they have prolonged exposure to theseenemies. New data suggests people who experience mild COVID-19 symptoms show themolecular signs of exhausted memory T cells and therefore could have a reduced ability tofight reinfection. On contrary people who develop severe COVID-19 symptoms may be betterprotected from reinfection. A recent study reported that the 82.1% of COVID-19 casesdisplayed low circulating lymphocyte counts . It has been reported that, in the case ofchronic viruses, continuous PD-1 expression causes T-cell exhaustion, and impairs theability of killing the infectious cells . The adumbration of patients with COVID-19 ischaracterized by a diminished lymphocyte percentage, with a similar proportion of CD4+and CD8+ T-cells. The quantity of T-cells, mostly CD8+ T-cells, presenting highexpression rates of late activity marker CD25 and exhaustion marker PD-1 increases.Therefore, SARS-CoV-2 is able to make changes by modifying the acquired immune system,including B and T cells. According to experiments, PD-1's expression, as an importantfactor in the induction and maintenance of circumferential tolerance keeping thestability of T-cells, has been found to have a higher percentage in different cells ofCOVID-19 patients. In an experiment conducted by Diao et al., on the patients withSARS-CoV-2, it was observed that the expression of PD-1 on the surface of T-cells wasincreased significantly; it was also shown that during the SARS-CoV-2 -induced disease,additional expressions of PD-1 and Tim-3 on the T-cells were directly related to thedisease's severity; the factors that were also increased in other viral infections. Tcell exhaustion" phenomenon could be reversed relatively easily, for example when the Tcells are no longer exposed to the virus or tumor. But unfortunately, although exhaustedT cells recovered from chronic infection (REC-TEX) regain some function and features ofmemory T cells (TMEM), they retain epigenetic scars indicating the control of geneexpression is "locked in" to their exhaustion history. Once T cells become exhausted,they remain fundamentally 'wired' to be exhausted-thus it may be hard to get them tobecome effective virus- and cancer-fighters again," said John Wherry, PhD, chair of thedepartment of Systems Pharmacology and Translational Therapeutics and director of thePenn Institute of Immunology in the Perelman School of Medicine at the University ofPennsylvania. Furthermore, COVID-19 may infect T lymphocyte cells and induce apoptosisand apoptotic markers. Lymphocytopenia was also found in the Middle East respiratorysyndrome (MERS) cases. MERS-CoV can directly infect human primary T lymphocytes andinduce T-cell apoptosis through extrinsic and intrinsic apoptosis pathways, but it cannotreplicate in T lymphocytes. However, it is unclear whether SARS-CoV-2 can also infect Tcells, resulting in lymphocytopenia. A study showed that T cells express a very lowexpression level of hACE2 on its cell surface and T-cell lines were significantly moresensitive to SARS-CoV-2 infection when compared with SARS-CoV . In other words, theseresults tell us that T lymphocytes may be more permissive to SARS-CoV-2 infection.Therefore, it is plausible that the S protein of SARS-CoV-2 might mediate potentinfectivity, even on cells expressing low hACE2, which would, in turn, explain why thetransmission rate of SARS-CoV-2 is so high. Through recent advances in genomic editing, Tcells can now be successfully modified via CRISPR/Cas9 technology. For instance, engaging(post-)transcriptional mechanisms to enhance T cell cytokine production, the retargetingof T cell antigen specificity or rendering T cells refractive to inhibitory receptorsignaling can augment T cell effector function. Therefore, CRISPR/Cas9-mediated genomeediting might provide novel strategies for inducing long term immunity againstCOVID-19.Immunotherapies with autologous T cells have become a powerful treatment optionfor many diseases like viral infection or cancer. These include the adoptive isolationand transfer of naturally-occurring virus/tumor-specific T cells and the transfer of Tlymphocytes that have been genetically modified . According to the investigator,exhausted virus-reactive CD8+ memory T cells will be isolated from patients with mildinfection using a modified antigen-reactive T cell enrichment (ARTE) assay. exhaustedvirus-reactive CD8+ memory T cells will be collected and both Programmed cell deathprotein 1(PDCD1) gene and ACE2 gene will be knocked out by CRISPR Cas9 in the laboratory.The lymphocytes will be selected and expanded ex vivo and infused back into patients.

Hôpital Européen Marseille

Pulmonary Fibrosis During Severe COVID-19 Pneumonia

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2, Acute Respiratory Distress Syndrome, Pulmonary Fibrosis

The COVID-19 pandemic is caused by the severe acute respiratory syndrome coronavirus 2(SARS CoV-2), an emerging coronavirus, which has already infected 192 million people witha case fatality rate close to 2%. About 5% of patients infected with SARS CoV-2 have acritical form with organ failure. Among critical patients admitted to intensive care,about 70% of them will require ventilatory assistance by invasive mechanical ventilation(MV) with a mortality rate of 35% and a median MV duration of 12 days. The most severelung damage resulting from SARS CoV-2 infection is the acute respiratory distresssyndrome (ARDS). The virus infects alveolar epithelial cells and capillary endothelialcells leading to an activation of endothelium, hypercoagulability and thrombosis ofpulmonary capillaries. This results in abnormal ventilation / perfusion ratios andprofound hypoxemia. To date, the therapeutic management of severe SARS CoV-2 pneumonialay on the early use of corticosteroids and Interleukin-6 (IL-6) receptor antagonist,which both reduce the need of MV and mortality. The risk factors of death in IntensiveCare Unit (ICU) are: advanced age, severe obesity, coronary heart disease, active cancer,severe hypoxemia, and hepatic and renal failure on admission. Among MV patients, thedeath rate is doubled in those with both reduced thoracopulmonary compliance and elevatedD-dimer levels. Patients with severe alveolar damage are at risk of progressing towardsirreversible pulmonary fibrosis, the incidence of which still remain unknown. Thediagnosis of pulmonary fibrosis is based on histology but there are some non-invasivealternative methods (serum or bronchoalveolar biomarkers, chest CT scan). We aim toassess the incidence of pulmonary fibrosis in patients with severe SARS CoV-2 relatedpneumonia. We will investigate the prognostic impact of fibrosis on mortality and thenumber of days alive free from MV at Day 90. Finally, we aim to identify risk factors offibrosis.

Sher-E-Bangla Medical College

Assessment of Long-term Effects (Complications) of COVID-19 in the Southern Part of Bangladesh - a Retrospective Observational Study.

Conditions: To Assess Long-term Effects of COVID-19 in Patients Who Were Affected With COVID -19

An outbreak of the novel coronavirus nCoV-19 (SARS-CoV-2), responsible for thecoronavirus disease-19 (COVID-19), was first detected in Hubei province, Wuhan, China, onDecember 31, 2019. It has rapidly spread globally with approximately 157,343,044confirmed cases and 3,278,510 deaths till 7th May, 2021 [1]. World Health Organization(WHO) declared COVID- 19 pandemic on 11th March 2020.The world is facing the second wave of Coronavirus Disease 2019 (COVID-19) pandemic whichis the most troublesome challenge to public health. The second wave is running and nobodyknows where we are in the course of this disease. It becomes a significant challenge forthe public health, science, and medical sectors [2].According to the World Health Organization, about 80% of infections are mild orasymptomatic, 15% result in moderate to severe symptoms (requiring oxygen) and about 5%are critical infections, which require ventilation.We are learning something new every day. Our understanding of the pandemic is growing andchanging daily. The world is focusing on the short term - flattening the curve, treatingthe sick and discovering a vaccine. But there is more to this pandemic than the shortterm.We know a lot about the transmission and clinical feature of COVID-19, but relativelylittle about what happens after someone recovers. Much is still unknown about howCOVID-19 will affect people over time. There's still much to be learned from those whohave recovered from COVID-19.

Hemex Health

Gazelle COVID-19 Test Clinical Accuracy Protocol

Conditions: COVID19

Gazelle COVID-19 is a fluorescent lateral flow immunoassay and accompanying Readerintended for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasalswab specimens from individuals who are suspected of COVID-19 by their healthcareprovider within 5 days of symptom onset. The study will be conducted To obtain data tomeasure the positive percent agreement and negative percent agreement of the GazelleCOVID-19 Test compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).Thestudy will assess Gazelle COVID-19 Test performance using dual mid-turbinate nasal swabsamples. This study will primarily assess Gazelle COVID-19 Test performance onsymptomatic subjects (within five days of onset of symptoms) at point of care (POC). Asubset of asymptomatic subjects will be enrolled after the symptomatic subject enrollmentis complete.

Russian Direct Investment Fund

Collaborative Study to Evaluate Heterologous Vaccination Against Covid-19 in Argentina

Conditions: COVID-19 Vaccine, COVID19

Randomized, open, multicenter, collaborative and adaptive non-inferiority trial toevaluate the immunogenicity and reactogenicity of the heterologous vaccination schedulesmade up of the combination of vaccines available in Argentina (Sputnik-V, AstraZeneca,Sinopharm and Moderna); and to compare the immunogenicity and reactogenicity ofheterologous and homologous vaccination schedules.

Afyonkarahisar Health Sciences University

Pain, Fatigue and Life Quality in COVID-19 Patients

Conditions: COVID-19 Pneumonia, Pain, Fatigue, Quality of Life

The aim in this study is to evaluate pain, fatigue and quality of life in patients withCovid-19 pneumonia in long-term follow-up and to investigate their relationship withpneumonia severity, age, presence of comorbidity and depression level.

University Hospital Dubrava

Gastrointestinal Motor Disorders (Esophageal and Anorectal) After COVID-19

Conditions: Gastrointestinal Motility Disorder

The patients who had COVID-19 infection, and after that reported for one of the signs ofgastrointestinal disorder (esophageal and anorectal) will be underwent to esophageal andanorectal motor monitoring investigation (HRM manometry) on standard protocol.

Abant Izzet Baysal University

Effect Of Musıc Therapy On Anxıety Levels In COVID-19 Pandemıc

Conditions: Anxiety

This study, which has a randomized controlled experimental design, was planned todetermine the effect of music therapy on the anxiety level of family health personnelworking in primary health care centers during the COVID-19 pandemic. The study will becarried out between 4 August and 31 December with nurses, midwives and other familyhealth personnel working in family health centers. Participants will be randomized intotwo groups, a control and an intervention group. Individuals in the intervention groupwill receive 15 minutes of music therapy once a day for 5 days. No intervention will bemade in the control group. Data Descriptive Question and State-Trait Anxiety Inventoryonline design; It will be collected on the Google Forms platform.. Data analysis will bedone using SPSS 20 program.

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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