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 310 of 530

University of Malaga

Digital Physiotherapy Practice in Long Covid-19 Patients

Conditions: Long COVID-19 Syndrome

The COVID-19 can cause important sequels in the respiratory system by bilateral pneumoniaand frequently presents loss of strength, dyspnea, polyneuropathies and multi-organicaffectation. Long COVID-19 has been defined as the condition occurring in individualswith a history of probable or confirmed SARS-CoV-2 infection, with related symptomslasting at least 2 months and not explainable by an alternative diagnosis. The practiceof digital physiotherapy presents itself as a promising complementary treatment method tostandard physiotherapy, playing a key role in the recovery of function in subjects whohave passed the disease and who maintain some symptomatology over time. The aims of thisresearch are to explore the effect of a digital physiotherapy intervention on functionalrecovery in patients diagnosed with Long COVID-19 and to identify the level of adherenceto the treatment carried out. Physiotherapy interventions acquires a fundamental role inthe recovery of the functions and the quality of life. As secondary objectives, the aimis to identify the satisfaction and perception of patients with the intervention and thepresence of barriers to its implementation (throught a qualitative research), as well asto evaluate the cost-effectiveness from the perspective of the health system. Aquasi-experimental pre-post study assessed initially and at the end of the 4-weekintervention the functional capacity (1-min STS and SPPB) and the adherence (software).The hypothesis of this research is that the implementation of a TR program presentspositive results. If hypothesis is confirmed, that would be an opportunity to define newpolicies and interventions to address this disease and its consequences.

Heinrich-Heine University, Duesseldorf

Vaccination Against COVID-19 in Chronic Kidney Disease

Conditions: Chronic Kidney Disease Stage 5 on Dialysis, Chronic Kidney Disease Stage 5 With Transplant, Vaccine Response Impaired

This is a prospective, multi-center, observational study that will enroll patientsreceiving dialysis (hemodialysis or peritoneal dialysis) or patients with kidneytransplantation who will be vaccinated against COVID-19.

Sanofi

RSV Burden in Outpatient Settings

Conditions: RSV Infection, Children, Only, Outpatient, Bronchiolitis, Otitis Media, Pneumonia

Strengthening outpatient low respiratory tract infection surveillance to document theburden of Respiratory Syncytial Virus (RSV)

Palas GmbH

Respiratory Aerosols in Patients With COVID-19 and Healthy Controls

Conditions: SARS-CoV-2 Infection, COVID19

The proposed study will investigate respiratory aerosols in SARS-CoV-2 (Severe AcuteRespiratory Syndrome Corona Virus 2) positive and negative children and adults with theResp-Aer-Meter (Palas GmbH). For this purpose, first, the measurement of respiratoryaerosols (particle sizes and concentration) with the Resp-Aer-Meter will be established.Thereafter, a comparison between polymerase chain reaction (PCR) SARS-CoV-2 positive andnegative participants (children and adults) will be conducted. In addition to themeasurement of aerosols, the clinical symptoms, lung function (FEV1) and laboratoryinflammatory markers will be analyzed.

Emilia Falcone, MD

Institut de Recherche Cliniques de Montreal (IRCM) Post-COVID-19 (IPCO) Research Clinic

Conditions: COVID19

Sample Size: n=570Accrual Ceiling: n=627Study Population: Patients age 18 to 100 yearsThe study duration includes 51 months to recruit patients and 24 months of totalfollow-up time counted from the first day of COVID-19 symptoms or date of confirmedCOVID-19 diagnosis.Study Design: This is a prospective, observational cohort study to evaluate the short-and long-term end-organ complications of COVID-19 and to establish a COVID-19 biobank.Participant Cohorts: 1. Individuals who had previous asymptomatic or mild COVID-19 (mild=never required supplemental oxygen during the acute phase of the infection) 2. Individuals who had previous moderate or severe COVID-19 (moderate=required supplemental oxygen by nasal cannula during the acute phase of the infection; severe=required supplemental oxygen by either high-flow nasal cannula, non-invasive positive pressure ventilation or intubation) 3. Individuals who had COVID-19 but did not have signs or symptoms related to COVID-19 lasting beyond 4 weeks from the date of COVID-19 symptom-onset or diagnosis 4. Individuals who have not had COVID-19 (i.e. individuals who tested negative for COVID-19 and who never had symptoms consistent with COVID-19)

The Joel Cornette Foundation

Hearts of Athletes

Conditions: Cardiac Involvement With COVID-19

The Hearts of Athletes study is being conducted to determine the heart involvement withCOVID-19 in athletes. This study aims to enroll any Adult (18 years of age or greater)• Athlete is defined as NCAA Collegiate Athlete, Professional Athlete, Military, orOlympic Athlete will be eligible for the study.With COVID-19• COVID-19 diagnosed via an RT-PCR (nasal or throat swab test) prior to enrollmentOr without COVID-19• Identified as a local Control participant (similar sport) to a participant withCOVID-19, who is willing to undergo a standard cardiovascular evaluationParticipants with and without COVID-19 will use their mobile devices to provide healthinformation, like symptoms, by answering survey questions daily for 30 days. Also,participants will allow their de-identified cardiac images to be sent to the Duke HeartCenter for blinded analysis.No physical risks are associated with this study. One possible risk, although minimal, isloss of confidentiality.

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigation on the Incidence and Course of COVID-19 in Patients With Prior, Ongoing or de Novo ITP. Evaluation of the Impact of COVID-19 Pandemic on the Management of ITP

Conditions: Immune Thrombocytopenia, ITP, COVID19, ITP Secondary to Infection

Multicenter retrospective and prospective observational study based on the collection ofsequential anonymized data from principal Italian ITP centers, to describe the clinicalcourse of ITP patients becoming infected by SARS-CoV-2 and of COVID-19 patientsdeveloping de novo ITP.

Radboud University Medical Center

Evaluation of Allied Healthcare in Patients Recovering From COVID-19

Conditions: COVID19, Allied Health Professionals, Primary Care, Retrospective Cohort, PROMs, Performance Measures, Prospective Cohort, National Dutch Program

SUMMARY Rationale: Allied health professionals (i.e., dietitians, exercise therapists,physical therapists, occupational therapists and speech and language therapists) mightplay an important role in the recovery of patients with COVID-19 who experiencelimitations in daily physical functioning and participation. However, the evidence basefor allied healthcare in patients with COVID-19 has yet to be established. To facilitatecare for people recovering from COVID-19 and to establish this evidence base, the Dutchministry has created a temporary regulation for primary care allied healthcarespecifically for patients with COVID-19.Objective: This study is setup alongside the temporary regulation and aims to evaluatethe longitudinal recovery trajectories and related costs of patients who visited aprimary care allied healthcare professional for the management of severe symptoms andactivity limitations and/or participation restrictions related to COVID-19.Study design: Prospective cohort study. Study population: 1,315 adult patients recoveringfrom COVID-19 with severe symptoms and activity limitations and/or participationrestrictions, and who are referred to a primary care allied health professional by ageneral practitioner or medical specialist within four months of the start of the diseasewill be eligible for this study.Intervention (if applicable): Although the nature of this study is non-experimental, theallied healthcare intervention can be considered experimental due to the novelty of thedisease.Main study parameters/endpoints: The primary outcome domain of this study isparticipation measured with the Utrechtse Schaal voor Revalidatie - Participatie(USER-P). The primary endpoint is set at 6 months. A 5 point difference will beconsidered clinically relevant for patients with COVID-19.Nature and extent of the burden and risks associated with participation, benefit andgroup relatedness: There are no specific risks involved with participation in this study,as it entails the completion of questionnaires over the timeframe of one year (at thestart of the treatment, the end of the treatment, 3 months, 6 months, 9 months and 12months). The load of the survey will be highest at months 3, 6 and 12 with a total of 74survey items. Input from patient representatives suggested that this number of items wasfeasible, especially because participants are allowed to complete the survey over anumber of days. Finally, none of the items in the survey are considered emotionallydistressing. The prescribed interventions are conform the recommendations of the bestavailable evidence and are in line with usual allied healthcare interventions. Therefore,risks are likely to be negligible conform usual allied healthcare.

European Hematology Association

Covid-19 in Hematological Malignancies

Conditions: COVID-19 Infection in Hematological Malignancies Patients

The overall purpose of this project is to better understand the epidemiology of COVID-19in patients with hematological malignancies (including hematopoietic stem cell transplantrecipients) in the different European Countries. The results obtained will allow us tobetter know the prevalence of this complication in the different categories of patientswith hematological malignancies (HMs). In order to attain the objectives previouslydescribed we will develop a multicentre, international, observational, retrospective andprospective study of consecutive cases of COVID-19 among HMs. There will be a clinicalfollow-up of the patients included in this study to observe the survival rate. Datacollected form this study will be evaluated with a descriptive analysis.

Kafrelsheikh University

Investigating the Role of 13cis Retinoic Acid in the Treatment of COVID-19 and Enhancement of Its Spike Protein Based Vaccine Efficacy and Safety.

Conditions: Covid19 Vaccine

Investigating the role of 13cis retinoic acid in the treatment of COVID-19 andenhancement of Its spike protein based vaccine efficacy and safety.

Pagination

  • First page « First
  • Previous page ‹‹
  • …
  • Page 27
  • Page 28
  • Page 29
  • Page 30
  • Current page 31
  • Page 32
  • Page 33
  • Page 34
  • Page 35
  • …
  • Next page ››
  • Last page Last »

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)

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