Skip to main content
Home
  • About
    • Board of Directors
    • Our Staff
    • Annual Reports
    • Policies
    • Fellowship
    • Careers
  • Projects
    • Column 1
      • Advancing Regulatory Science
        • Oncology Multi-Regional Clinical Trials
        • Rare Disease Innovation Roundtable
      • Animal Health & Veterinary Medicine
        • Antimicrobial Use in Food Animals
        • Cross-Sectoral Health Threats
        • Industry SWOT Analysis
      • Expanded Access
        • E-request App
        • Navigator
        • Resources for COVID-19
      • FDA Patient Listening Sessions
    • Column 2
      • Food & Nutrition
        • About
        • Food Traceability
        • Healthy Rule Roundtables
        • Nutrition Facts Label
        • Produce Safety Stakeholder Dialogue
        • Retail Dietitian Toolkit
      • Improving Access to FDA Information
        • Understanding FDA & FDA-Regulated Products
        • Improving Access to Publicly Available FDA Information
      • Research
        • About
        • IMEDS
          • IMEDS Inquiry
        • Post Market Research
        • RAISE
        • Real World Data
        • Regulatory Science Accelerator
    • Substance Use Disorders
  • News and Events
    • Innovations in Regulatory Science & Policy Awards
    • Events
    • News
    • Publications
    • 2026 Annual Public Meeting
  • Expanded Access eRequest
  • facebook
  • twitter
  • linkedin
  • youtube
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 130 of 254

University of Sao Paulo

Home-based Exercise in COVID-19 Survivors

Conditions: COVID19, SARS (Severe Acute Respiratory Syndrome), SARS-CoV Infection

The physical inactivity promoted by the patient's hospitalization, including thoseinfected with the coronavirus, can lead to an important health impairment, includingatrophy and loss of muscle function. Thus, a prospective study will be conducted toassess the effect of a home-based exercise training program on health outcomes andquality of life in COVID-19 survivors.

University Hospital of Ferrara

Recovery Profiles in Patients With SARS-CoV-2 Outcomes Undergoing Rehabilitation

Conditions: Covid19_rehabilitation

COVID19 patients survivors, after discharge from hospital show reduced lung function andreduced ability to exercise. Furthermore, mental health problems including stress,anxiety and depression and a low quality of life were observed. The prospectiveobservational study involves COVID19 patients who have needed rehabilitation at theUniversity Hospital of Ferrara. Patients receive comprehensive rehabilitation based ontheir specific needs in both acute and subacute rehabilitation. At the end of hospitalrehabilitation, patients are offered a program to be carried out at home for bothphysical and psychological problems. A range of demographic and clinical data will becollected. Patients will also undergo a battery of functional, cognitive andpsychological tests at 12, 26 and 52 weeks from the infection onset. Moreover, a specificassessement (both clinical and instrumental) on the pain symptom experienced, wherepresent, will be done.

Cristina Avendaño Solá

Clinical Trial to Assess the Efficacy of MSC in Patients With ARDS Due to COVID-19

Conditions: Acute Respiratory Distress Syndrome, COVID-19 Pneumonia

A double-blind, randomized, controlled, clinical trial to evaluate the efficacy andsafety of MSC (mesenchymal stromal cells) intravenous administration in patients withCOVID-induced ARDS compared to a control arm.

Vladimír Džavík

Semaglutide to Reduce Myocardial Injury in PATIents With COVID-19

Conditions: COVID19, Myocardial Injury

With the results of this study the investigators aim to identify an effective treatmentthat will reduce morbidity and mortality of patients with symptomatic COVID-19 infection,which would in turn reduce the burden on the healthcare system by decreasing the need forintensive care.Objectives: The main objective of this research is to determine if once weekly treatmentwith the GLP-1 agonist semaglutide for 4 doses will reduce cardiac as well as non-cardiaccomplications of COVID-19 infection.Study Plan: The study design is prospective randomized open-label blinded-evaluation(PROBE). Eligible patients with symptomatic COVID-19 infection and an enhanced riskprofile as described above, who have been admitted to hospital due to symptoms ofCOVID-19 infection but do not as yet require critical care will be approached toparticipate in this study. Provided there are no exclusion criteria and the participantsagree by means of documented written informed consent, The participants the participantswill be randomized to receive s.c. semaglutide 0.25 mg s.c. or control immediately afterrandomization and then 0.5 mg s.c. at Day 7, Day 14 and Day 21. Blood will be drawn atDay 7±2 and Day 14±2 for the cardiac troponin biomarker and safety parameters. ECG willbe obtained at Day 7±2 and Day 14±2. Primary outcome will be assessed on Day 28.Primary outcome measure: A composite of (1) death from any cause or (2) mechanicalventilation (invasive or non-invasive) at 28 days.Major secondary outcome measure:(1) an elevation to >99th percentile URL upper reference limit (URL) in those with abaseline cardiac troponin level ≤99th percentile URL; or 3x elevation from baseline inthose with a baseline cardiac troponin >99th percentile URL; measured at 1 week (7-days)post randomization.Other major secondary outcome measure:A composite of 1. Death from any cause, mechanical ventilation or vasopressor or ECLS support at 28 days 2. an elevation to >99th percentile URL in those with a normal baseline troponin level; or 3x elevation from baseline in those with a baseline troponin; measured at 1 and 2 weeks (7±2 and 14±2 days) post randomization.

Hillel Yaffe Medical Center

Delivery During Covid-19 Pandemic: Implications for Obstetrics, Maternal Psychopathology, and Mother-Infant Relationship

Conditions: Delivery; Trauma, COVID19

The Coronavirus 2019 (COVID-19) pandemic has brought about unprecedented social, economicand mental-health challenges, especially for vulnerable populations such as pregnant andpost-partum females. In this study, we aimed to evaluate the relations between the fearof COVID-19 and postnatal depression symptoms.

Institut d'Investigació Biomèdica de Bellvitge

Pirfenidone Compared to Placebo in Post-COVID19 Pulmonary Fibrosis COVID-19

Conditions: Fibrotic Pulmonary Sequelae Post-COVID19 Infection

Study population: Patients with fibrotic lung sequelae after recovery from acute phase ofsevere COVID19 pneumonia Objectives: To evaluate the effect of pirfenidone administeredfor 24 weeks in patients who have pulmonary fibrotic changes after suffering severeCOVID19 pneumonia, analysed by - % change in forced vital capacity (FVC) - % fibrosis in high resolution computed tomography (HRCT) of the lung

Constant Therapeutics LLC

Angiotensin 1-7 as a Therapy in the Treatment of COVID-19

Conditions: COVID-19

Phase 2 ,double blind, randomized study of therapy with Angiotensin 1-7 in COVID-19patients. 120 confirmed SARS-CoV-2 infected patients who exhibit moderate- clinicalsymptoms including dyspnea, cough and fever, hospitalized in the KETER department inseveral hospitals in Israel, will be enrolled. 60 patients will receive Ang 1-7subcutaneously 500 mcg/kg /day. 60 patients will receive placebo : NaCl 0.9% 2 ml-control arm .Treatment duration: 14 days or until clinical improvement that enables discharge fromhospital.(the shortest time will be the limiting factor in treatment duration). Follow-up-30 days.14-30 days after discharge from hospital: we will contact the patient via phone to askquestions related to any possible adverse reaction to the drug and general health.

Uniformed Services University of the Health Sciences

Blood Purification With Seraph 100 Microbind Affinity Blood Filter for Treatment of Severe COVID19 Observational Study

Conditions: COVID19

This is a multi-center, observational study that will enroll 1) patients with severeCOVID-19 who have agreed to undergo therapy with Seraph® 100 under the existing EUA; 2)patients (medical record data) that have been previously treated with the Seraph® 100after the date of the EUA approval (17 April 2020), but before the date that the study isapproved at the study site, and 3) a convenience sample of patients (medical record data)in a historical control group who were admitted to the ICU at participating sites withsevere COVID-19 infection, meeting the EUA treatment criteria, but not treated withSeraph® 100 up to the time the PURIFY-OBS protocol is approved at the site

International Centre for Diarrhoeal Disease Research, Bangladesh

Cytokine Storm Among Bangladeshi Patients With COVID-19

Conditions: Cytokine Storm, COVID-19

COVID -19, first reported in Wuhan, China, strikes the world hard as a pandemic byspreading up to 213 countries. Bangladesh is also facing its havoc with the death of 3000among 229,185 cases at its 141st day. Most are mild cases presenting with influenza-likeillness with expected recovery. According to World Health Organization, the overallglobal case fatality rate is currently estimated to be 2.9%. However, patients havingsevere or critical illness presenting with severe respiratory distress, ARDS or shocksuffer most with mortality rates of 49.0-61.5%. Studies suggest that there are mild orsevere cytokine storms in severe patients, which is an important cause of death. Anexaggerated and uncontrolled release of pro-inflammatory mediators by an overly activatedimmune system is known as cytokine storms (CS) or cytokine release syndrome (CRS) whichhas an important role in the hemodynamic insults seen in very ill COVID-19 patients. Thisaberrant release of pro-inflammatory cytokines causes lung damage, myocarditis, acutekidney injury, etc. In this study, the investigators aim to estimate the burden ofcytokines and their correlation with the magnitude of the severity of COVID-19 illness inBangladeshi adults.

Francis Crick Institute

SARS-CoV-2 (COVID-19) Longitudinal Study: Understanding Susceptibility, Transmission and Disease Severity (Legacy Study)

Conditions: SARS-CoV Infection

The study aims to investigate SARS-CoV-2 susceptibility, transmission and diseaseseverity in healthcare workers and patients.Residual specimens from an existing collection of samples in viral inactivating bufferand derivatives and serum from the Crick COVID-19 Consortium Testing centre (Cohort A1)and additional biological material collected prospectively (Cohorts A2 and B) will beused for research into SARS-CoV-2 transmission, evolution and immune control. Thistesting centre is a partnership between UCLH and The Francis Crick Institute to provideCOVID 19 RT PCR testing for healthcare workers (HCWs) and patients in London Hospitalsand care homes. A third group (Cohort C) of the study will allow for collaborative workwith other REC approved research studies that have used the Crick COVID-19 ConsortiumTesting centre and will involve the use of study samples already collected from eachstudy to be analysed under the SARS-CoV-2 Longitudinal Study end points

Pagination

  • First page « First
  • Previous page ‹‹
  • …
  • Page 9
  • Page 10
  • Page 11
  • Page 12
  • Current page 13
  • Page 14
  • Page 15
  • Page 16
  • Page 17
  • …
  • Next page ››
  • Last page Last »

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)

Subscribe for updates from the Reagan-Udall Foundation for the FDA

Subscribe
(202) 849 - 2075
1333 New Hampshire Ave, NW
Suite 420
Washington, DC 20036
admin@reaganudall.org
  • facebook
  • twitter
  • linkedin
  • youtube

© Reagan-Udall Foundation for the FDA
© Reagan-Udall Foundation for the FDA