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      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
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        4. FDA Patient Listening Sessions
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          6. Regulatory Science Accelerator
      3. Substance Use Disorders
  • News and Events
      1. Innovations in Regulatory Science & Policy Awards
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      3. News
      4. Publications
      5. 2026 Annual Public Meeting
  • Expanded Access eRequest
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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 10 of 64

University of Karachi

A Clinical Trial of Gargling Agents in Reducing Intraoral Viral Load Among COVID-19 Patients

Conditions: COVID-19

Pakistan is a resource restraint country, it's not possible to carry out coronavirustesting at mass scale. Simple cost effective intervention against the present pandemic ishighly desirable.For patients: Identifying an antiviral gargle that could substantially reduce thecolonies of COVID-19 residing in mouth and oro-naso-pharynx is likely to reduce the viralload. Such reduction in the viral load through surface debridement could aid theeffective immune response in improving the overall symptoms of the patients.For dentists: This study is important because the nature of the dental professioninvolves aerosol production, carrying out dental work on asymptomatic patients carryingcoronavirus puts the entire dental team at a great risk of not only acquiring theinfection but also transmitting it to the others. Antiviral gargles could be used bydentist and their auxiliaries as prophylaxis.For physicians and nurses: The risk of morbidity and mortality is high among physiciansand nurses involved in the screening and management of Covid-19 patients. Globally, over215 physicians and surgeons have died while taking care of Covid-19 patients. The causeof death is attributed to high exposure of viral load. The antiviral gargles and nasallavage can decrease the fatalities among doctors and nurses.Thus, patients, physicians, nurses and dentists, all could be benefited with thisfindings of this study.

Tongji Hospital

The Safety of Chemotherapy for Patients With Gynecological Malignancy in High-risk Region of COVID-19

Conditions: Gynecological Cancer

A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (COVID-19)emerged at December 2019 in Wuhan, China, and soon caused a large global outbreak. Thedelayed treatment for many chronic diseases, due to the concern of SARS-CoV-2 infection,is an increasing serious problem. Here the investigators investigate the safety ofchemotherapy for patients with gynecological malignancy in Wuhan, the center of high-riskregions of COVID-19.

CytoDyn, Inc.

Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)

Conditions: Coronavirus Disease 2019

The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140)administered as weekly subcutaneous injection in subjects with severe or criticalCOVID-19 disease.

Instituto de Investigación Marqués de Valdecilla

Observational Study of Follow-up of Hospitalized Patients Diagnosed With COVID-19 to Evaluate the Effectiveness of the Drug Treatment Used to Treat This Disease. COVID-19 Registry

Conditions: SARS-CoV-2

The infection caused by COVID19 worldwide makes it necessary to monitor drugsadministered for the treatment of patients hospitalized with SARS-CoV-2. In order to knowmore about the efficacy and safety of the treatments used, researchers from theCantabrian health service have developed an observational study, in the form of anambispective registry, in which clinical data from patients treated with the differentdrugs currently recommended by the Spanish Agency of Medicines and Health Products(SAMHP) and the Ministry of Health, or others that may arise, are collected and analyzed.Although the conduct of clinical trials is a priority at this time, we cannot lose theclinical experience that is currently being generated, which may allow us to improve thetherapeutic strategies for future patients.

Centro Nacional de Investigaciones Oncologicas CARLOS III

Clinical Trial to Evaluate Efficacy of 3 Types of Treatment in Patients With Pneumonia by COVID-19

Conditions: COVID-19 Pneumonia

In absence of vaccine and medications specifically designed to treat SARS-CoV-2 disease,identifying treatment options is critical at this time to control the disease outbreak.For this, we have designed a phase II trial of efficacy and safety with 3 branches ofdifferent combinations of treatment to identify which is the best early treatment optionfor patients with pneumonia due to SARS-CoV-2 (Covid-19) Identifying treatment options asearly as possible is critical to the SARS-CoV-2 outbreak response. Currently, there is noapproved vaccine for the disease and the treatments being used are not specificallydesigned for the SARS-CoV-2 virus, but are different groups of drugs used for otherpathologies with mechanisms of action that justify their use because they inhibit entryof the virus into virus cells or proteases.The study aims to compare Imatinib 400mg, Baricitinib 4mg or supportive treatment,administered for 7 days in the setting of SARS-CoV-2 pneumonia treatment.Patients who meet inclusion criteria and do not have any exclusion criteria will berandomized to receive open treatment 1:1:1

Kafrelsheikh University

Assessment the Activity Value of Isotretinoin (13- Cis-Retinoic Acid ) in the Treatment of COVID-19 ( Isotretinoin in Treatment of COVID-19) (Randomized)

Conditions: COVID19

Assessment the Activity Value of Isotretinoin (13- Cis-Retinoic Acid ) in the Treatmentof COVID-19Mahmoud ELkazzaz(1),Tamer Haydara(2), Mohamed Abdelaal(3), Abedelaziz Elsayed(4) ,YousryAbo-amer(5), Hesham Attia(6), Quan Liu(7)' Tim Duong(8) and Heba Sahyon(9) 1. Department of chemistry and biochemistry, Faculty of Science, Damietta University, Egypt. 2. Department of Internal Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt 3. Department of Cardiothoracic Surgery, Faculty of Medicine, Kafrelsheikh University, Egypt 4. Department of Pharmaceutical Biotechnology, Faculty of Pharmacy, Tanta University, Egypt. 5. Hepatology,Gastroenterology and Infectious Diseases Department, Mahala Hepatology Teaching Hospital, Egypt 6. Department of Immunology and Parasitology, Faculty of Science, Cairo University, Egypt. 7. School of Life Sciences and Engineering, Foshan University, Laboratory of Emerging Infectious Disease, Institute of Translational Medicine, The First Hospital of Jilin University, Changchun, China. 8. Montefiore Health System and Albert Einstein College of Medicine, New York, United States of America. 9. Chemistry Department, Faculty of Science, Kafrelsheikh University, Egypt. - This clinical study is the first clinical study in literature (submitted on 20 April, 2020) which demonstrated that Isotretinoin will provide complete protection against COVID-19AbstractThe COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) has infected over 100 million people causing over 2.4 million deaths overthe world, and it is still expanding. There is an urgent need for targeted and effectiveCOVID-19 treatments which has put great pressure on researchers across the world fordeveloping effective drugs. In this clinical study we attempt to demonstrate Isotretinoincould be an effective and promising treatment for SARS-CoV-2 based on the intracellularmechanism of SARS-CoV-2 transmission and consequences caused. Isotretinoin could stronglyinhibit both inflammation and viral entry in severe acute respiratory syndromecoronavirus 2 infection via decreasing the overproduction of early responseproinflammatory cytokines (interleukin-6 ) which are over expressed in COVID-19 andcontributed to disease progression, poor outcomes, vascular hyper permeability andmultiorgan failure in patients infected with COVID-19. It could also block the entry ofCOVID-19 by inhibiting androgenic factors that induce serine 2 transmembrane protease(TMPRSS2) expressions.. In addition to inhibiting of Angiotensin-converting enzyme-2(ACE2), Angiotensin T1 protein and Angiotensin II-mediated intracellular calcium releasepathway which is responsible for COVID-19 cell fusion and entry, ACE2-expressing cellsare prone to SARS-CoV-2 infection as ACE2 receptor facilitates cellular viral entry andinvasion. Moreover, isotretinoin is a potential repressor and inhibitor of papain-likeprotease (PLpro), which is a lethal protein expressed by COVID-19 genes and is an enzymeof dubiquitination which facilitates virus replication in patients with COVID-19.Thegenome of Middle East Respiratory Syndrome Coronavirus is recognized by melanomadifferentiation-associated protein-5 (MDA5), retinoic acid inducible gene-1 (RIG-1) andendosomal toll-like receptor 3 (TLR3) as pathogen-associated molecular patterns. Thisrecognition resulted in the formation of type-1 interferon (IFN1). As an evasionmechanism, virus synthesize proteins that hinder the production IFN1 in the pathway.13-cis retinoic acid induced significant upregulation of toll-like receptor 3 (TLR3),mitochondrial antiviral-signaling protein (MAVS) and IFN regulatory factor 1 expressionin a time-dependent. Furthermore, 13 cis Retinoic Acid (13 cis RA) could be an effectiveand promising treatment for SARS-CoV-2 owing to its ability to increase CD4 cells andinduce mucosal IgA antibodies that are less prone to Antibody Dependent Enhancementprocess (ADE) and responsible for passive mucosal immunity in the respiratory tract. ADEis a phenomenon in which antiviral antibodies facilitate viral infection of target immunecells and, in some cases, make a second infection worse, such as dengue fever (denguevirus), By inducing IgA antibodies, 13 cis retinoic acid enhances mucosal immunity and isknown to be a potent IgA isotype.13 Cis retinoic acid induced significant upregulation oftoll-like receptor 3 an immune boosting action that may result in an immune response todsRNA intermediate leading to the production of type I IFNs which is important to enhancethe release of antiviral proteins for the protection of uninfected cells. Isotretinointherapy has furthermore proven anti-platelet and fibrinolytic activities which mayprotect patients infected with covid-19 from widespread blood clots. From this point, wesuggest that isotretinon will be the Immunity passport" in the context of COVID-19

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.

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.

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.

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.

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