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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 50 of 159

City of Hope Medical Center

Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma

Conditions: Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed

Plasma from patients who have recovered from coronavirus disease 2019 (COVID-19) isreferred to as COVID-19 convalescent plasma (CCP), and may contain antibodies againstSARS-CoV-2, the virus responsible for COVID-19. CCP infusion is being evaluated as atherapeutic or prophylactic approach in COVID-19 patients. The goal of this study is tohelp develop a bank of convalescent plasma in California, especially in medicallyunderserved communities particularly affected by the disease. In parallel, CCPadministered to COVID-19 patients will be collected and analyzed to determine whether theantibody profile correlates with clinical outcome. The purpose of this non-therapeuticstudy is to learn more about the CCP antibody profile and the effect it may have intreating COVID-19 infection.

Surgical Systems Research Group

Western Kenya Integrated COVID-19 Response

Conditions: COVID19

To respond to the COVID-19 pandemic, investigators will be deploying community healthworkers, equipped with mobile technology, and accompanied by youth to visit householdsdoor to door to screen for symptoms of COVID-19, isolate, test, and manage suspectedcases of COVID-19. The community health workers and youth will educate households aboutpreventive measures including frequent handwashing and home management of mild cases.Simultaneously, investigators will work with nurses, doctors, and clinical officers, totest and treat more severe cases of COVID-19 in health facilities. Our goals are: tovisit every household in Siaya county covering a population of close to 1 million, and totrain and support health workers working in 32 health facilities with oxygen capacity inSiaya to reduce the morbidity and mortality related to COVID19 and other conditions.

National Cancer Institute (NCI)

Well-Being and Health-Related Quality of Life in Cancer Patients and Survivors During the COVID-19 Pandemic

Conditions: Covid-19 Infection, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

This study investigates the well-being and health-related quality of life in cancerpatients and survivors during the COVID-19 pandemic. Using questionnaires may helpresearchers gain an understanding of how experiences during the COVID-19 pandemic (e.g.,exposure, risk factors, testing, isolation, seropositivity, hospitalization, loss offamily or friends, loss of income), may impact multiple domains of health-related qualityof life (physical, emotional and social well-being), and other areas such asCOVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms),and disruptions to health care, finances, and social interactions.

National Cancer Institute (NCI)

Assessment of the Psychosocial Impact of the COVID-19 Pandemic on the MD Anderson Cancer Center Workforce

Conditions: Covid-19 Infection

This study investigates the impact of the COVID-19 pandemic on the psychosocial health ofemployees of MD Anderson Cancer Center. Epidemics have been shown to promotepsychological stress among medical staff in high risk areas, which may lead to mentalhealth problems. Assessing how the pandemic is affecting employees may allow for morecomprehensive actions to be taken to protect the mental health of employees.

University of Sao Paulo

Evaluation of Systemic and Oral Conditions of Pregnant Women and Their Babies, With Exposure to COVID-19 Infection

Conditions: Exposure During Pregnancy, Corona Virus Infection

This research aims to investigate the incidence, clinical condition, mode of transmissionand laboratory data of women and their babies, who were exposed to COVID-19 infectionduring pregnancy. This project will consist of 4 subprojects, being that Subprojects 1and 2, will be of the observational, longitudinal type of prospective Cohort; Subproject3 will be of prevalence; Subproject 4 will be case-control. Subproject 1- This study aimsto assess periodontal condition and quality of life before and after delivery of womenwith excess weight gain or not, with exposure to coronavirus-sars-cov2. Subproject 2-Identify the proteins differentially expressed in saliva associated with COVID-19infection during the 3rd trimester of pregnancy in obese and eutrophic patients.Subproject 3- Assess the prevalence of congenital syndrome in babies associated with thepresumed maternal infection with SARS-CoV-2. Subproject 4- Case-control study in whichnewborns are submitted to clinical examination, being a group with congenitalmalformations and their respective controls and an interview with the mother was carriedout.

Johns Hopkins University

Decitabine for Coronavirus (COVID-19) Pneumonia- Acute Respiratory Distress Syndrome (ARDS) Treatment: DART Trial

Conditions: COVID-19

This is a a randomized double blind placebo controlled Phase 2 trial with a 12 patientlead-in to evaluate safety, prior to full enrollment to an additional 28 patients (for atotal of 40 patients) to assess efficacy of decitabine in the treatment of critically illpatients with COVID-ARDS. The patients will be randomized in a 1:1 ratio to receivestandard of care plus Decitabine or standard of care plus saline based placebo. Theprimary objective is to determine safety and efficacy of decitabine for COVID-19 ARDSbased on clinical improvement on a 6-point clinical scale.

Centre Chirurgical Marie Lannelongue

Predicting the Progression to Chronic Fibrosis of Lung Lesions Related to Covid-19 Infection From Chest CT Images

Conditions: CoV2 SARS Pneumonia

The main differences observed between SARSCoV-2 pneumonia and other epidemic viralpneumopathies (e.g., seasonal influenza) are the greater infectivity of SARSCoV-2, theclinical severity of the disease, particularly in young patients without co-morbidities,and the observation of radiological images related to significant parenchymal aggressionin a large number of patients.The lesions in the acute phase correspond essentially to bilateral ground glass opacitymore or less associated with condensations which would be markers of more severeinfections.The major scope of the lesions in the acute phase raises the question of whether or notthe scanning anomalies are completely resolved over time, and the possible impact on lungfunction. This risk of sequelae is very important to study given the large number ofpatients affected by SARSCoV-2, especially since these are often young patients whoappear to be "healthy".In the current context of the CoV-2 SARS pandemic, the improved quality and availabilityof diagnostic scanners provides a wealth of information on the semiology and progressionof lung disease with minimal exposure to ionizing radiation. A majority of hospitalizedpatients with SARSCoV-2 received a CT scan in the early phase of the disease. Indeed, theFrench Society of Radiology has recommended the performance of a CT scan withoutinjection in thin sections in case of suspicion or for confirmation of the diagnosis inpatients presenting initial or secondary clinical signs of severity and justifyinghospital management due to the initial lack of reagents for performing biological tests(RT-PCR) and the high sensitivity of the CT scan and its specificity in epidemic periods.The present study aims to study the kinetics of lung involvement in SARS CoV 2, to studythe predictive character of the chest CT scan performed at the patient's discharge on theexistence of radiological sequelae at 3 months but also at 1 year in order not tomisunderstand the constitution of late fibrosis after partial resolution of the CTimages. The investigatos will study the correlation between possible radiologicalabnormalities and the clinical presentation (patient symptoms and lung function). Therigorous follow-up of these patients will allow us to set up, if necessary, earlytreatment of the detected abnormalities (inhaled corticoids in case of bronchial orbronchiolar damage, study of the place of an anti-fibrosis treatment in case offibrosis,...).

University of Chicago

Low-dose Tocilizumab Versus Standard of Care in Hospitalized Patients With COVID-19

Conditions: COVID-19

Tocilizumab is an effective treatment for severe coronavirus disease 2019 (Covid-19)pneumonia and related inflammation. Given limited global supplies, clarification of theoptimal tocilizumab dose is critical. We conducted an open-label, randomized, controlledtrial evaluating two different dose levels of tocilizumab in Covid-19 (40mg and 120mg).Randomization was stratified on remdesivir and corticosteroid at enrollment. The primaryoutcome was the time to recovery. The key secondary outcome was 28-day mortality.

University Hospital Southampton NHS Foundation Trust

SafeFit Trial: Virtual Clinics to Deliver Universal Interventions in People With Cancer

Conditions: Cancer, COVID

Trial Phase: Phase III: Interventional Trial: Virtual clinics to deliver universalinterventions to maintain and improve physical health, nutritional state andpsychological wellbeing in people with cancer who are following social distancingguidance: A COVID-19 targeted trial.Indication: Male or female participants, aged over 18 years old with suspicion orconfirmed diagnosis of cancer (does not require histological confirmation)Objective: To investigate the efficacy of remote multimodal universal interventionsdelivered via virtual clinics to improve physical function as measured by theEORTC-QLQ-C30.Secondary Objective:To investigate the efficacy of remote multimodal universal interventions delivered viavirtual clinics to improve emotional function, quality of life, participant activation(PAM), behaviour change and the effect it has on health economics (EQ-5D-5L).Exploratory Objective:Overall Survival and adherence to the intervention/advice using validated tools ordevelopment of a web-based toolkit.

Chinese University of Hong Kong

Coronavirus Disease 2019 (COVID-19) During Pregnancy: Prevalence of Seroconversion, Effect on Maternal and Perinatal Outcomes and Risk of Vertical Transmission (COVID-MAP)

Conditions: COVID-19

The objectives of this proposal are to: 1) determine the rate of SARS-CoV-2seroconversion in unselected pregnant women in Hong Kong; 2) determine the rate ofSARS-CoV-2 infection in women presenting with miscarriage and stillbirth; 3) follow thepregnancy course and perinatal outcome of confirmed COVID-19-infected pregnant cases; 4)determine the risk and characteristics of vertical transmission; and 5) evaluate theplacental barrier, immune response and fetal damage in vertical transmission ofSARS-CoV-2. A series of longitudinal and cross-sectional observational studies, and alaboratory-based study will be conducted to fulfil the 5 objectives.

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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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