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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 100 of 254

Harvard Medical School (HMS and HSDM)

Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury

Conditions: COVID, Acute Kidney Injury, Critical Illness

The aim is to describe the epidemiology and determine the independent risk factors formortality and acute organ injury in AKI and to assess the impact of different treatmentstrategies on survival. This will allow the development of prevention strategies anddesign of appropriately powered intervention studies.

Bandim Health Project

OPV as Potential Protection Against COVID-19

Conditions: Poliovirus Vaccine, Oral, COVID, Mortality, Morbidity, Non-specific Effects of Vaccines

Since the 1960s, studies have shown that oral polio vaccine (OPV) may have beneficialnon-specific effects, reducing morbidity and mortality from other infections than polio.Such beneficial non-specific effect have been observed for other live vaccines, includingmeasles, smallpox and BCG vaccine. For BCG, the vaccine for which the mechanism has beenstudied the most, the effects appear to be mediated through the innate immune system. TheCOVID-19 pandemic caused by the novel coronavirus SARS-CoV-2 has now caused over 7.1million cases and >400,000 deaths worldwide. As everywhere else, it is anticipated thatin Africa the older part of the population will be at risk of severe COVID-19. OPV iswidely used in Africa, but for children. Both polio and coronavirus are positive-strandRNA viruses, therefore it is likely that they may induce and be affected by common innateimmune mechanisms.In a randomised trial at the Bandim Health Project in Guinea-Bissau, the investigatorswill assess the effect of providing OPV vs no vaccine to 3400 persons above 50 years ofage. The trial will have the power to test the hypothesis that OPV reduces the combinedrisk of morbidity admission or death (composite outcome) by at least 28% over thesubsequent 6 months.

University Hospital, Toulouse

Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection

Conditions: COVID-19

There is a pandemic in the world by COVID-19. Currently, the pharmacological curative orprophylactic treatments for this infection are not known. Recent studies have suggestedthat Hydroxy-Chloroquine could be effective in vitro and in vivo against COVID-19. Themain objective of this study is to assess in patients with autoimmune disease treatedwith long course Hydroxy-Chloroquine initiated before the pandemic COVID-19 had anindependent protective effect on the risk or the severity of infection with COVID-19.

Brigham and Women's Hospital

Ravulizumab and COVID-19

Conditions: COVID19, Thrombotic Microangiopathies, Acute Kidney Injury

Ultomiris (Ravulizumab), is a monoclonal antibody that specifically targets terminalcomplement products and is proposed for the treatment of COVID-19 inducedmicrovasculature injury and endothelial damage leading to thrombotic microangiopathy(TMA) causing acute kidney injury (AKI). Ravulizumab is to be used for participants witha confirmed diagnosis of COVID-19 who clinically or diagnostically present withdeteriorating renal function. Ravulizumab causes immediate and sustained inhibition ofthe terminal complement cascade. The use of ravulizumab could ameliorate COVID-19 inducedkidney injury due to TMA, shorten hospital stay, and improve the overall survival.

Lahore General Hospital

Waxing and Waning of Serum SARS CoV-2-IgG Level in COVID-19 Exposed Population

Conditions: COVID19

This study will define the kinetics of IgG responses to both N and S proteins in thesubjects who suffered from COVID 19 and then had recovered and those who were previouslyundiagnosed but were seropositive. These subjects will be followed for four months toevaluate the levels of antibodies in these people.

Assiut University

Comorbidities And Complications Associated With Covid-19 Infection

Conditions: COVID19

To evaluate the spectrum of comorbidities and complications and its impact on theclinical outcome in hospitalized patients with coronavirus disease 2019 (COVID-19).

Centre Hospitalier Universitaire, Amiens

Physiopathology and Sequelae of COVID-19 Infection

Conditions: COVID19, TSH, Cortisol

The data obtained from Covid-19 infections seem to suggest that the immunogenesis ofCovid-19 could in some cases be the result of immune dysregulation. On the other hand,endocrine damage is possible at the tile of Covid-19 infection (mainly thyroid,adrenal,and hypothalamus). These disorders are autoimmune or linked to degeneration.The main objective is to assess the thyroid function (thyrotropic axis) as well as thecorticotropic adrenal function of patients who have had Copvid-19 pneumonia. Thesecondary objectives is to describe the pathophysiological mechanisms of pulmonary andvasculothrombotic involvement of Covid-19

Universidad Politecnica de Madrid

Active Pregnancy Against COVID-19

Conditions: Pregnancy Complications, Pregnancy, High Risk, Pregnancy Induced Hypertension, Newborn Morbidity, Fetal Growth Retardation, Fetus Disorder, Weight Gain, Maternal, Maternal-Fetal Relations

Historically and traditionally, the recommendations related to physical exercise duringpregnancy have been based more on moral or cultural issues than on scientific evidence.During some phases of history, pregnancy has meant a period of seclusion for women (notonly physical). One of the adverse consequences has been the common recommendation ofrest as a general rule for pregnant women.Scientific evidence from recent years has achieved a better understanding of the processof pregnancy and childbirth as well as maternal and fetal responses to exercise.Currently, both from a scientific and clinical/obstetric point of view, there is no doubtabout the benefits of an active pregnancy for entire body of pregnant woman, and even herchild. In fact, risks of a sedentary lifestyle are applicable to the pregnancy situation,even more with important associated complications during pregnancy and postpartum period.Unfortunately, the impact of COVID-19 has caused an unprecedented global crisis, in thissense the necessary measures taken by the different administrations, especially in termsof confinement causes (from now on) a large number of complications affecting differentpopulations. In summary a complex situation without established prevention strategiesexists.The pregnant population is, due to the nature of the gestation and delivery process, oneof the population groups with the highest risk of adverse outcomes and associatedcomplications and whose consequences include the mother, fetus, newborn and evenchildren. According to an important body of scientific literature and based on anepigenetic effect, the intrauterine environment can be a determining factor for thefuture human being to evolve regardless of complications and pathologies (cardiovascular,metabolic, psychic, emotional). This is demonstrated by numerous recent scientificevidences that confirm the unfortunate association between an adverse intrauterineenvironment (due to various factors) and observable postnatal pathologies in infants.In addition, current publications report the large number and variety of alterations thatthe COVID-19 situation causes in pregnant women and that includes the entire femaleorganism. This complex situation does not only affect aspects of a physical orphysiological nature, but also psychic and emotional factors. In summary, a new state ofconfinement or similar situations in the near future (impossibility of groupings,distance between people), avoid during the daily life of pregnant women one of theimportant and recent recommendations made by the international scientific community: apregnancy physically active.This is especially relevant, due to the dangerous association between complications of apsychological or emotional nature during pregnancy with pre, peri and postnatal disorders(low birth weights, perinatal complications, altered and prolonged deliveries, etc.),which affect not only to the mother and can determine the health of the future humanbeing. According to the scientific literature and based on an epigenetic effect, theintrauterine environment can be a determining aspect in the health of the future humanbeing and the prevention of complications and pathologies (cardiovascular, metabolic,psychic, emotional). This is demonstrated by numerous and recent scientific evidencesthat confirm the unfortunate association between an adverse intrauterine environment (dueto various factors) and different pathologies during and after pregnancy.It is evident the change that COVID-19 and its effects will generate in the lifestyle ofthe pregnant population and the increased probability of suffering associated pathologiesin the next 24-36 months. No preventive actions have yet been planned in Spain and itspublic hospitals against the impact of COVID-19 on the quality of life of pregnant women.It is urgent to design and perform an adequate strategy of intervention for its possibleprevention. From the scientific point of view, the recommendations are clear andconcrete, an aerobic exercise program, designed and supervised by professionals from theSciences of Physical Activity and Sports, is the best option for pregnant women.In this sense, in the last 30 years, physical exercise has proven to have many benefitsfor pregnant women, without causing risks or adverse effects on maternal-fetalwell-being. This is confirmed by an important body of scientific literature ongestational physical exercise and its effects on pregnancy outcomes.

Centre Hospitalier le Mans

Identifying Functional and Psycho-social Complaints After Hospitalization for SARS-CoV-2 Infection( COVID 19)- REPERCOV

Conditions: SARS-COV2, COVID19

Since December 2019, China and then the rest of the world have been affected by the rapidspread of a new coronavirus infection called SARS-CoV-2 (severe acute respiratorysyndrome coronavirus), the clinical expression of which is called Covid-19 (CoronavirusDisease 2019).It is estimated that around 20% of symptomatic patients will be severe enough to warranthospitalization, of which around 5% will be in intensive care.Organ damage is multiple in Covid infection: respiratory, digestive, renal, neurological,cardiovascular due to the infection or its care. There is also a psychological and socialimpact of the infection or of the care that should be measured.In this context, investigator will assess the physical and psychological complaints ofpatients who have presented a severe form of SARS-CoV-2 infection.The final objective being to identify the needs to offer follow-up adapted to thisemerging pathology.

Federal University of Rio Grande do Sul

Video Dance Class and Unsupervised Physical Activity During Covid-19 Pandemic in People With Parkinson's Disease

Conditions: Parkinson Disease, Parkinson Disease 10

The aim of this study is to analyze the impact of video dance class and unsupervisedphysical activity on clinical-functional parameters, self-isolation and non-motorssymptoms in people with Parkinson's disease during the Covid-19 pandemic.

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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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