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Home
  • About
      1. Board of Directors
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  • 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 20 of 134

Roche Pharma AG

Tocilizumab Treatment in Patients With COVID-19

Conditions: SARS-COV2

A phase II clinical trial will be carried out with the objective of studying the impactof the administration of Tocilizumab on the evolution of the acute respiratory distresssyndrome (ARDS) in patients with severe or critical SARS-CoV-2 infection. Due to the highmortality of severe forms of SARS-CoV-2 and for ethical reasons, a control arm will notbe included. Patients will be recruited by signing an informed consent and the baselinevariables of interest will be recorded. Tocilizumab will be administered in one or twodoses, depending on the case, and will be followed up for 30 days. The response totreatment, survival and evolution will be studied. Factors associated with improvement ofARDS and survival will be identified through multivariate analyzes. The results will becompared with those reported internationally.

University of Milan

The Effect of Sitagliptin Treatment in COVID-19 Positive Diabetic Patients

Conditions: COVID19, Diabetes Mellitus, Type 2, CKD

The COVID-19 pathology is frequently associated with diabetes mellitus and metabolicsyndrome. In the epidemic outbreak that exploded at the beginning of 2020 in the LombardyRegion, about two thirds of the patients who died from COVID-19 were affected by diabetesmellitus. COVID-19 occurs in 70% of cases with an inflammatory pathology of the airwaysthat can be fed by a cytokine storm and result in severe respiratory failure (10% cases)and death (5%). The pathophysiological molecular mechanisms are currently not clearlydefined. It is hypothesized that the transmembrane glycoprotein type II CD26, known forthe enzyme activity Dipeptilpeptidase 4 of the extracellular domain, may play a main rolein this condition. It is in fact considerably expressed at the level of parenchyma andpulmonary interstitium and carries out both systemic and paracrine enzymatic activity,modulating the function of various proinflammatory cytokines, growth factors andvasoactive peptides in the deep respiratory tract. Of particular interest is the factthat Dipeptilpeptidase 4 has been identified as a cellular receptor for S glycoprotein ofMERS-COV. In the case of the SARS-COV 2 virus, the main receptor is theAngiotensin-Converting Enzyme 2 protein, but a possible interaction withDipeptilpeptidase 4 also cannot be excluded. The selective blockade of Dipeptilpeptidase4 could therefore favorably modulate the pulmonary inflammatory response in the subjectaffected by COVID-19. This protein is also known for the enzymatic degradation functionof the native glucagon-like peptide 1, one of the main regulators of insulin secretion.This is why it is a molecular target in the treatment of diabetes (drugs that selectivelyinhibit Dipeptilpeptidase 4 are marketed with an indication for the treatment of type 2diabetes). It is believed that the use of a Dipeptilpeptidase 4 inhibitor in people withdiabetes and hospitalized for Covid-19 may be safe and of particular interest for anevaluation of the effects on laboratory and instrumental indicators of inflammatory lungdisease. Among the drugs that selectively block Dipeptilpeptidase 4, the one with thegreatest affinity is Sitagliptin.

Consorci Sanitari de Terrassa

Influenza Vaccination, ACEI and ARB in the Evolution of SARS-CoV2 Infection

Conditions: COVID19, Influenza Vaccination, ACE Inhibitors, ARB, Antihistamine Allergy, Amantadine

Some authors have proposed the use of the flu vaccine to reduce the severity of COVID-19cases, while some have proposed the use of ACE Inhibitors (ACEI) or Angiotensin Receptorblockers (ARB), since this virus shares hemagglutinin as a transmission mechanism andacts on the ACE2 enzyme during infection.Other authors described how none of the elderly patients receiving antihistamines andazythromycin in two nursing homes in Toledo -Spain- during the first wave died or neededhospital admission, even considering that 100% of residents had a positive serologicaltest after that wave. Other authors have described a positive evolution in patientsreceiving amantadine for their Parkinson's disease.The aim is to evaluate whether the admitted patients who are previously vaccinated orthose who were already receiving these treatments showed a better evolution.

Medpace, Inc.

Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS

Conditions: ARDS, COVID19, Influenza, Human

This is a randomized, double-blinded, placebo-controlled study of AVM0703 administered asa single intravenous (IV) infusion to patients with moderate or severe immediatelylife-threatening Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 or influenza(A or B). The study is designed to evaluate the safety, tolerability, andpharmacokinetics of single dose of AVM0703 in these ARDS patients.

Bristol-Myers Squibb

Safety and Efficacy of Therapeutic Anticoagulation on Clinical Outcomes in Hospitalized Patients With COVID-19

Conditions: Cardiovascular Diseases, COVID-19

The coronavirus disease 2019 (COVID-19) global pandemic caused by the severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2) has caused considerable morbidity andmortality in over 170 countries. Increasing age and burden of cardiovascularcomorbidities are associated with a worse prognosis among patients with COVID-19. Inaddition, serologic markers of more severe disease including coagulation abnormalitiesand thrombocytopenia, are not uncommon among patients hospitalized with severe COVID-19infection and are more common in patients who died in-hospital. As the COVID-19 pandemiccontinues to grow, there is a pressing need to identify safe, effective, and widelyavailable therapies that can be scaled and rapidly incorporated into clinical practice.Understanding the putative mechanism of increased mortality risk associated with abnormalcoagulation function and cardiac injury is critical to guide studies of promisingtherapeutic interventions. Published and anecdotal reports indicate that endothelialdysfunction and thrombosis are common in critically ill patients with COVID-19, includingreports of diffuse microvascular thrombosis in the lungs, heart, liver, and kidneys.Patients with cardiovascular disease (CVD) and CVD risk factors are known to haveendothelial dysfunction and a heightened risk of thrombosis. A recent study of COVID-19inpatients from Wuhan, China observed that an elevated D-dimer level greater than 1 ug/mLwas associated with an 18 times higher risk of in-hospital death, underscoring theimportance of increased coagulation activity as a potential modifiable risk marker thatmay drive end-organ injury. Given the established link between endothelial dysfunctionand thrombosis in patients with cardiovascular disease, and the association betweencoagulopathy and adverse outcomes in patients with sepsis, the association betweenincreased coagulation activity, end-organ injury, and mortality risk may represent amodifiable risk factor among COVID-19 patients with critical illness. Therefore, wepropose to conduct a randomized, open-label trial of therapeutic anticoagulation inCOVID-19 patients with an elevated D-dimer to evaluate the efficacy and safety.

Memorial Sloan Kettering Cancer Center

A Study of N-acetylcysteine in Patients With COVID-19 Infection

Conditions: COVID-19

The study researchers think that a medication called N-acetylcysteine can help fight theCOVID-19 virus by boosting a type of cell in your immune system that attacks infections.By helping your immune system fight the virus, the researchers think that the infectionwill get better, which could allow the patient to be moved out of the critical care unitor go off a ventilator, or prevent them from moving into a critical care unit or going ona ventilator.The US Food and Drug Administration (FDA) has approved N-acetylcysteine to treat theliver side effects resulting from an overdose of the anti-inflammatory medicationTylenol® (acetaminophen). N-acetylcysteine is also used to loosen the thick mucus in thelungs of people with cystic fibrosis or chronic obstructive pulmonary disease (COPD).This study is the first to test N-acetylcysteine in people with severe COVID-19infections.

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.

Vanda Pharmaceuticals

ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 Infection

Conditions: Coronavirus Infection

This is a randomized, double-blind placebo-controlled trial to investigate the efficacyand safety of tradipitant 85 mg orally given twice daily to treat inflammatory lunginjury associated with severe or critical COVID-19 infection.On evaluation for enrollment, participant will need to meet all inclusion and exclusioncriteria. If participant consents, they will be randomized 1:1 to treatment with eithertradipitant 85 mg PO BID or placebo in addition to standard of care for COVID-19infection as per the protocol at the treating hospital. NEWS 2 will be assessed atscreening and daily following randomization. Inflammatory lab markers as detailed shouldbe collected once per day in the morning, preferably at the same time every morning. Allenrolled participants will have whole blood collected for whole genome sequencing.

Gilead Sciences

Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection (COVID-19)

Conditions: SARS-CoV2 Infection

The primary objective of this study is to provide expanded access of remdesivir (RDV) forthe treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.

University of Oxford

A Study of a Candidate COVID-19 Vaccine (COV001)

Conditions: Coronavirus

A phase I/II single-blinded, randomised, multi-centre study to determine efficacy, safetyand immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1nCoV-19 in UK healthy adult volunteers aged 18-55 years. The vaccine will be administeredintramuscularly (IM) into the deltoid region of the arm

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Status

  • Unknown status (64)
  • Active, not recruiting (37)
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  • Enrolling by invitation (5)
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Intervention Type

  • (-) Drug (134)
  • Other (17)
  • Biological (11)
  • Dietary Supplement (4)
  • Combination Product (3)
  • Device (1)
  • Procedure (1)
  • Radiation (1)

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© Reagan-Udall Foundation for the FDA