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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 40 of 254

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Moxibustion Plus Cupping in Convalescent Patients With COVID-19

Conditions: COVID-19, Convalescence

This trial is designed to evaluate the efficacy and safety of moxibustion plus cupping inthe convalescence of COVID-19.

Chinese University of Hong Kong

Coronavirus Disease 2019 (COVID-19) Study of Hospitalized Patients in Hong Kong

Conditions: Coronavirus Infections

COVID-19 may cause another world-wide epidemic. This study is divided into 2 arms: (1)Prospective longitudinal observational study involving patients with laboratory-confirmedCOVID-19 and (2) Retrospective study on patients with laboratory-confirmed COVID-19.Arm 1:We will collect EDTA blood, stool samples, rectal swab, urine, saliva, and specimens fromupper respiratory tract (nasopharyngeal aspirate or flocked swab), and lower respiratorytract (sputum or tracheal aspirate) on daily, alternate day, or weekly basis asappropriate.Arm 2:The remainder of specimens that were submitted for laboratory investigation as part ofclinical management will be retrieved. Those specimens will only be used after allclinically indicated testing and confirmation procedures have been completed. Assistancefrom the Public Health Laboratory Service, Department of Health, will be invited toretrieve samples as well as participate in this study.Patients hospitalized for pneumonia in medical wards and ICU at the Prince of WalesHospital tested negative for COVID-19 will be recruited as controls.Understanding the clinical, virological, microbiological and immunological profiles ofthis infection is urgently needed to facilitate its management and control.

Robert W. Alexander, MD

Use of cSVF Via IV Deployment for Residual Lung Damage After Symptomatic COVID-19 Infection

Conditions: Pulmonary Alveolar Proteinosis, COPD, Idiopathic Pulmonary Fibrosis, Viral Pneumonia, Coronavirus Infection, Interstitial Lung Disease

COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, includingFibrotic Lung Disease due to inflammatory and reactive protein secretions damagingpulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up..March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas ofNew York-New Jersey, Washington, and California.Immediate attention is turned to testing, diagnosis, epidemiological containment,clinical trials for drug testing started, and work on a long-term vaccine started.The recovering patients are presenting with mild to severe lung impairment as a result ofthe viral attack on the alveolar and lung tissues. Clinically significant impairment ofpulmonary function appears to be a permanent finding as a direct result of theinterstitial lung damage and inflammatory changes that accompanied.This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascularfraction (cSVF) deployed intravenously to examine the anti-inflammatory and structuralpotential to improve the residual, permanent damaged alveolar tissues of the lungs.

University of Catanzaro

Biomarkers for Identification of COVID-19 Infection

Conditions: Coronavirus

Acute lung injury represents the most severe form of the viral infection sustained bycoronavirus disease 2019 (Covid-19) also named as SARS-CoV-2, a new virus emerged inDecember 2019 in Wuhan (China). The diagnosis is clinical and patients develop flu-likesyndrome with fever and cough; patients with clinical symptoms can perform a swab test,including molecular and/or antigen swab, for diagnosis of positivity to Covid-19. Even ifdiagnosis and treatment are well described, to date, this viral pandemic infectioninduces an increased mortality in the world. The aim of the present project is toevaluate specific biomarkers that could be used for patient stratification and for tailortherapy in COVID-19 infected patients.

Pontificia Universidad Javeriana

P2Et Extract in the Symptomatic Treatment of Subjects With COVID-19

Conditions: COVID, Coronavirus Infection, SARS-CoV 2, COVID19

Antioxidants, and particularly polyphenols, have shown protection in respiratorypathologies, which is related to the decrease in the severity of the clinical picture andsuppression of inflammation. This suppression of inflammation may be related to theinhibition of NF-kB polyphenols, where its activation is related to the stimulation of150 stimuli including cytokines (IL-1β, IL-6, THF-α, GM-CSF, MCP-1), TLRs, among others.There may be other additional mechanisms that can help control virus-induced respiratorypathologies, among which are the regulation of reactive oxygen species (ROS) associatedwith tissue destruction caused by the virus and a selective antiviral action can bereported. direct.The standardized P2Et extract obtained from C. spinosa, by the Immunobiology Group of thePontificia Universidad Javeriana, is highly antioxidant, decreases lipid peroxidation andtissue damage and induces complete autophagy in stressed or tumor cells. The induction ofa full autophagic flow could inhibit the replication of beta-coronaviruses likeSARS-CoV-2. Furthermore, P2Et can decrease the factors involved in tissue damage byreducing IL-6 and decrease ILC2 cells of the lung in animals with lung metastases(unpublished data).These antecedents suggest that the supplementation of patients with COVID-19 with theextract P2Et, could improve their general condition and decrease the inflammatorymediators and the viral load.

University of Zurich

Microbiota in COVID-19 Patients for Future Therapeutic and Preventive Approaches

Conditions: Corona Virus Infection, ARDS, Coinfection

In light of the rapidly emerging pandemic of SARS-CoV-2 infections, the global populationand health care systems are facing unprecedented challenges through the combination oftransmission and the potential for severe disease. Acute respiratory distress syndrome(ARDS) has been found with unusual clinical features dominated by substantial alveolarfluid load. It is unknown whether this is primarily caused by endothelial dysfunctionleading to capillary leakage or direct virus induced damage. This knowledge gap issignificant because the initial balance between fluid management and circulatory supportappear to be decisive. On progression of the disease, bacterial superinfectionfacilitated by inflammation and virus related damage, has been identified as the mainfactor for patient outcome, but the role of the host versus the environment microbiomeremains unclear.The overarching aim of the present research proposal is to improve therapeutic strategiesin critically ill patients with ARDS due to SARS-CoV-2 infection by advancing thepathophysiological understanding of this novel disease. This research thus focuses oninflammation, microcirculatory dysfunction and superinfection, aiming to elucidate riskfactors (RF) for the development of severe ARDS in SARS-CoV-2 infected patients andcontribute to the rationale for therapeutic strategies. The hypotheses are that (I) theprimary damage to the lung in SARS-CoV-2 ARDS is mediated through an exaggeratedpro-inflammatory response causing primary endothelial dysfunction, and subsequentlyacting two-fold on the degradation of the lung parenchyma - through the primary cytokineresponse, and through recruitment of the inflammatory-monocyte-lymphocyte-neutrophilaxis. The pronounced inflammation and primary damage to the lung disrupts the pulmonarymicrobiome, leading secondarily to pulmonary superinfections. (II) Pulmonary bacterialsuperinfections are a significant cause of morbidity and mortality in COVID-19 patients.Pathogen colonization main Risk Factor for lower respiratory tract infections. Toestablish colonization, pathogens have to interact with the local microbiota (a.k.a.microbiome) and certain microbiome profiles will be more resistant to pathogen invasion.Finally, (III) Handheld devices used in clinical routine are a potential reservoir andcarrier of both, SARS-CoV-2, as well as bacteria causing nosocomial pneumonia.

King's College London

Testing the Accuracy of a Digital Test to Diagnose Covid-19

Conditions: COVID-19

The Covid-19 viral pandemic has caused significant global losses and disruption to allaspects of society. One of the major difficulties in controlling the spread of thiscoronavirus has been the delayed and mild (or lack of) presentation of symptoms ininfected individuals, and the insufficient Covid-19 testing capacity in the UK. Thiswarrants the development of alternative diagnostic tools that reliably assess Covid-19infection in the early stages of infection, while also being low- cost, low-burden, andeasily administered to a wide proportion of the population.This study aims to validate machine learning models as a diagnostic tool that predictsinfection with SARS-CoV-2 based on app-reported symptoms and phenotypic data, against the'gold-standard' swab PCR-test. This study will take place within the Covid Symptom Studyapp, the free symptom tracking mobile application launched in March 2020.

King's College Hospital NHS Trust

Endothelial Function, Inflammation and Organ Dysfunction in COVID-19

Conditions: COVID, Shock

COVID-19 is a rapidly evolving pandemic with approximately 5% of all patients whichrequire intensive care unit admission. In critically ill patients infected with COVID-19,approximately 15% had severe shock requiring medications to increase blood pressure. Itappears that blood vessel tone is altered and microcirculation is not well regulated inpatients with COVID-19. The underlying pathophysiology and contributing factors areunknown. The association with subsequent organ dysfunction and outcome is also unclear.Therefore, the investigators aim to investigate serial changes of relevant biomarkers inthis population to improve the understanding of this disease, to investigate theassociation with clinically important outcomes and to find out how best to treatpatients. The data will serve to develop strategies for individualised management of thishigh-risk group.

Guy's and St Thomas' NHS Foundation Trust

Efficacy and Safety of Angiotensin II Use in Coronavirus Disease(COVID)-19 Patients With Acute Respiratory Distress Syndrome

Conditions: COVID, Acute Respiratory Distress Syndrome

This study aims to find out whether the use of angiotensin II, which is a drug to raiseblood pressure has been approved by European Medical Agency in August 2019, as an add-onmedication to increase blood pressure in patients with COVID-19, acute severe lunginjury, inflammation and severe shock, compared with standard medication. In addition,the investigators will collect the data of Anakinra, another drug which is frequentlyused in this condition to reduce inflammation.The investigators will collect clinical data and outcomes from critical care patients.The investigators will analyse for whom these drugs are most beneficial and explorewhether there are any patients who don't benefit or have side effects.

University Hospital Muenster

AKI Biomarkers in Coronavirus(COVID)-19

Conditions: COVID, Acute Respiratory Failure, Acute Kidney Injury

This research aims to investigate the role of daily measurement of urinary cell cyclearrest markers and other serum and urinary biomarkers to predict the development of acutekidney injury in critically ill patients with COVID-19 and acute respiratory disease.

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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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