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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 254

Vastra Gotaland Region

COVID-19 Research in Organ Transplant Recipients

Conditions: Transplant Recipients

COVID-19 is a global major public health emergency that disproportionately affectspatients with risk factors such as advanced age, heart and lung disease, diabetes,hypertension, as well as compromised immunity. Despite the recent worldwide emergence ofthis disease and its rapid progression to a pandemic, very little is known about therisks facing solid organ recipients. The study aims to elucidate the prevalence ofsymptomatic, subclinical, and asymptomatic infection in the transplanted population byassessing their immunological response to SARS-CoV-2 infection. This will be studiedseroepidemiologically in the whole cohort and retrospectively in transplanted patientsadmitted to hospital for COVID-19.Primary objective: to elucidate the cumulative prevalence of SARS-CoV-2 infection in thetransplanted population related to symptoms and hospitalizations; to assess the magnitudeof immunological response and seroconversion kinetics for COVID-19. Secondary objectives:To examine the influence of medical parameters on COVID-19 infection and immune responsesuch as: age, comorbidities current and recent pharmacological treatment, organtransplanted, and blood type, HLA genotype.Study design:Part 1: Longitudinal cohort study for seroepidemiology and disease burden. Part 2:Retrospective case-series for seroconversion kinetics and clinical course assessment.Study population:All solid organ transplanted patients in Sweden

The Hospital for Sick Children

Mental Health Support for SickKids Children and Families During COVID-19 Using Established eHealth Interventions

Conditions: Anxiety Disorder of Childhood or Adolescence

Coronavirus disease 2019 (COVID-19) and associated emergency measures (EM) havedramatically impacted the lives of children/adolescents (children) and families. Theclosure of schools, social and recreational activities, and modifications to workenvironments has led to significant changes in the way children and families are working,living and socializing. Although the impact on the mental health of children and familieshas not been well researched, it is anticipated that already stressed children andfamilies with pre-COVID-19 mental health challenges are at significant risk fordeterioration in their mental health. As such, the implementation, and evaluation(specifically: feasibility, acceptability and barriers) of virtual-care interventions toalleviate child and family anxiety and enhance family functioning are critical.Virtual-care also optimizes health equity initiatives in reducing social, economic andenvironmental barriers to services that can improve or maintain mental health (WHO, 2017;MOHLTC, 2018).The current study will evaluate an adapted virtual-care cognitive behavioural therapy(CBT) program for children with anxiety (VC-CBT). CBT has a strong evidence-base intreating children with anxiety disorders (Higa-McMillan, Francis, Rith-Najarian, andChorpita, 2016; Seligman and Ollendick, 2011), with increasing evidence supporting theefficacy of virtual-care CBT for childhood anxiety disorders (Carpenter, Pincus, Furr,and Comer, 2018; Slone, Reese, and McClellan, 2012). This study aims to evaluate thefeasibility, participation barriers related to social determinants of health (SDH) andacceptability of this virtual-care intervention in addressing mental health challengesassociated with the COVID-19 pandemic and ensuing EM in the immediate time-period. Earlyevaluation of this virtual-care intervention will enable future scale-up of thisintervention during the post-pandemic recovery time-period and during subsequent COVID-19waves, if necessary.

Versailles Hospital

RT-PCR on Conjunctival Sample for the Detection of SARS-CoV-2 in Patients With Covid-19

Conditions: SARS-CoV Infection, Pinkeye

the purpose of the study is to study the detection of SARS-Cov-2 virus in the conjunctivaof covid-19 patients and the presence or absence of conjunctivitis in these patients

University Hospital, Lille

Risk of Air Contamination During Visceral Surgery in COVID19 Patients

Conditions: SARS-COV2, Surgery, COVID

Sars-Cov2 has been found in the digestive tract, as well as the respiratory tract.Protection of health care workers during surgery has been increased and some guidelinesadvocate for abandoning laparoscopy in COVID19 patients for fear of contamination,evenghtough this does not benefit the patient. However, Sars-Cov2 contamination riskduring visceral surgery remains unknown. Inadequate protection is unnecessary costful andcan be inefficient if too binding. Our hypotheses are that 1) Sars-Cov 2 can travelthrough droplet and air during visceral surgery. 2) Laparoscopy, because of thepneumoperitoneum and its leaks, warrant more air contamination whereas laparotomy warrantmore droplet contamination, which would justified increased protection.

Imperial College London

COVID-19 and Cancer Patients

Conditions: Cancer, SARS-COV2

Routinely collected data will be used to assess the morbidity and mortality of cancerpatients following a positive COVID-19 infection.

Hampshire Hospitals NHS Foundation Trust

SINUS WASH Pilot Study in Adults Testing Positive for COVID-19

Conditions: Coronavirus Infection

COVID-19 is highly infectious and transmission of the virus is thought to be similar tothat of influenza which can be transferred through droplets released when a personcoughs, sneezes or talks. Studies have shown that nasal rinsing and mouth washes may bean important way to deliver treatments that could reduce the amount of a virus that ispresent in the nose and mouth. This also could mean that there is less virus available topass on to others. We want to see if the use of nose rinses and mouth washes usingPovidone-Iodine will reduce the the amount of virus in the nose and throat of people whohave tested positive for COVID-19 disease and also reduce the spread of infection withintheir household.

Centre Hospitalier Intercommunal Creteil

Use of PCR-Sars-CoV-2 in Children

Conditions: COVID-19

The VIGIL study was set up at the beginning of the pandemic, in the spring of 2020, at atime when diagnostic testing for SARS-CoV-2 had to be performed according to specificclinical criteria (even if no clinical picture suggestive of COVID had been clearlyidentified). The management of sick young children (with respiratory tract infection thatcould be attributed to COVID) by pediatricians (infectious diseases specialists,emergency physicians, general practitioners, and outpatients) was facilitated by analgorithm whose objective was to help define the indications for SARS-CoV-2 PCR andsubsequently for antigenic testing. The current technique of deep nasopharyngeal swabbing(for PCR or antigenic testing) is delicate and difficult in children, and is therefore aserious handicap for community-based screening, especially since infectious episodes arefrequent in children. Since then, nasal self-tests that can be easily used in childrenhave been commercialized and have facilitated screening.Because of the similarity between the clinical signs of respiratory tract infections inchildren, it is often impossible to distinguish between different viral respiratoryinfections and epidemics may overlap in time. However, the identification of the pathogenis the key to improve management of these infectious diseases. The VIGIL study istherefore continuing, still facilitated by the existence of an active pediatric networkexisting for 20 years. ACTIV AFPA and GPIP have created networks of hospital andambulatory pediatricians who actively participate in various observatorieshttps://www.jpeds.com/article/S0022-3476(17)31606-2/fulltext To date, these observatorieshave resulted in the publication of more than 80 articles in international journals(https://www.activ-france.com/fr/publications).

Egyptian Military Medical Services

Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory in Treating COVID-19 Disease

Conditions: Corona Virus Infection, Middle East Respiratory Syndrome (MERS), Acute Respiratory Distress Syndrome, Coronavirus Infection, COVID-19, SARS-CoV 2

The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant fortreatment and to assess the potential in reducing mortality and morbidity rates inCOVID-19 patients. The study was approved by the ethical committee of the Egyptian Centerfor Research and Regenerative Medicine in 11-5-2020.

Maastricht University Medical Center

COVID-19, Obesity and Lifestyle in Children

Conditions: COVID-19, Obesity, Childhood, Lifestyle, Lifestyle, Healthy, Overweight, Childhood, Children, Only, Family

This study aims to evaluate the impact of the COVID-19 pandemic and its measures onlifestyle in Dutch children between 4 - 18 years.

S.L.A. Pharma AG

EPA-FFA to Treat Hospitalised Patients With COVID-19 (SARS-CoV-2)

Conditions: SARS-CoV-2

This is an double-blind, randomized, placebo controlled phase III study in hospitalizedsubjects with confirmed SARS-CoV-2.

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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)

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