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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 100 of 159

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.

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)

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.

Assistance Publique - Hôpitaux de Paris

Disability Following Hospitalization in People of Working-age Surviving SARS-CoV-2 Infection - COVID-19

Conditions: COVID-19

The purpose of the study is to describe disability following hospitalization in people ofworking-age surviving COVID-19.

University of Minnesota

Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 Acute Respiratory Distress Syndrome

Conditions: COVID19, SARS-CoV Infection, ARDS, ARDS, Human

Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patientson mechanical ventilation.

Augusta University

[COVID-19] Reduction of Sars-CoV-2 Oral Viral Load With Prophylactic Mouth Rinse

Conditions: COVID19

The purpose of this study is to test the effectiveness of prophylactic mouth rinses inreducing the amount of viruses, specifically SARS-CoV-2 in the oral cavity. This researchwill guide dental and medical providers on best practices to be performed prior to dentaland medical procedures involving the oral cavity.

McGill University Health Centre/Research Institute of the McGill University Health Centre

COVID-19 Immunologic Antiviral Therapy With Omalizumab

Conditions: COVID19

To evaluate if omalizumab is effective in decreasing mortality in severe hospitalizedCOVID-19 cases.

Fondazione IRCCS Policlinico San Matteo di Pavia

Early Use of Hyperimmune Plasma in COVID-19

Conditions: COVID19

The study assesses the efficacy of early administration of hyperimmune plasma in covid-19patients who are on CPAP or intubated. Efficacy is measured as a 2 point decrease in theWHO scale

Boston Children's Hospital

HEALthy Brain and Child Development Study - COVID-19 Supplement

Conditions: Child Development, Prenatal Infection, Prenatal Stress, COVID19

The purpose of this study is to advance the scientific understanding of how a prenatalCOVID-19 infection and associated psychological distress influences infantneurodevelopment. This project will aim to shed light on how families and childdevelopment are impacted by the current COVID-19 pandemic and will work to better supportthese families and children as they grow.

Sinocelltech Ltd.

To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19

Conditions: COVID-19, SARS-CoV-2

The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlledPhase II/III clinical trial. It will be conducted at selected investigational sitesglobally. The study is comprised of 2 parts.

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Status

  • Unknown status (76)
  • Recruiting (48)
  • Active, not recruiting (27)
  • Not yet recruiting (5)
  • Enrolling by invitation (3)

Intervention Type

  • (-) Other (159)
  • Drug (17)
  • Biological (15)
  • Behavioral (6)
  • Diagnostic Test (6)
  • Procedure (4)
  • Dietary Supplement (1)
  • Radiation (1)

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