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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 150 of 159

Assistance Publique Hopitaux De Marseille

Evolution of Protective Immunization Against COVID-19 Among Hospital Workers in Health Care Facilities

Conditions: COVID19

To measure the immunization rate (seroneutralization) in a population of exposed hospitalworkers (nursing staff assigned to dedicated COVID-19 care units, laboratory staffhandling COVID-19 samples).

Saglik Bilimleri Universitesi

Changing of Prostate Specific Antigen Value in Patients With Covid-19

Conditions: COVID19, Prostate Specific Antigen

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) caused a worldwide pandemicin over 100 years. The disease caused by this newly discovered virus was called Covid-19.In this study, we aimed to evaluate changing of PSA value in patients with Covid-19.

IRCCS Azienda Ospedaliero-Universitaria di Bologna

The Effectiveness of Respiratory Tele-rehabilitation After COVID-19 Pneumonia Related: a Randomized Controlled Trial

Conditions: Respiratory Failure, SARS-CoV-2, COVID19, ARDS, Interstitial Pneumonia, Respiratory Rehabilitation, Dyspnea, Quality of Life, Coronavirus Infections

In recent months, more and more studies suggest tele-rehabilitation as a means to beexploited to reduce the risk of contagion.The intent of our study is to verify the effectiveness of a tele-rehabilitationintervention through the application of a respiratory rehabilitation program supported bycontact with physiotherapists, in patients with outcomes from SARS-CoV-2 infectiondischarged from the various medical departments and taken over by physiotherapists afterphysiatric evaluation.Faced with the same rehabilitation program prescribed to all patients, the primaryobjective of our study is to detect whether patients supported by remote rehabilitationafter hospitalization improve both adherence to the rehabilitation program andcardiorespiratory endurance and dyspnea symptoms assessed with the Six Minute WalkingTest scale (6MWT). This test is validated for multiple pathologies, including idiopathicpulmonary fibrosis, the clinic of which could be comparable to the outcomes ofcoronavirus interstitial pneumonia as suggested by the literature.The secondary objectives concern the assessment of the impact of physical exerciseassisted by tele-rehabilitation detected through: the assessment of the quality of life(Saint George Respiratory Questionnaire );the assessment of autonomy in daily lifeactivities (Barthel Index Dyspnea Scale), the evaluation of the variation in thoracicexpansion and lung volumes (with COACH , an instrument for respiratory physiotherapy thatmeasures the inspiratory volume in ml); the evaluation of muscle strength and endurance(One Minute Sit To Stand) ; the detection of dyspnea during the execution of theexercises (Modified Borg scale); the assessment of the functionality of the lower limbs(Short Physical Performance Battery)

Deborah O'Connor

Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1c

Conditions: COVID-19 Vaccine, Breastmilk

This will be a prospective observational study of lactating mothers who are planning to,have scheduled or have received vaccination against SARS-COV-2 (COVID-19 vaccine).Mothers may have delivered at Mount Sinai Hospital or may be from the general publicrecruited by social media or word of mouth. As the study participants will be lactatingmothers, they will not be under the care of the investigators. Due to lack ofinformation, we are unsure of an appropriate sample size but envision we will recruit atleast 10 women each immunized with the approved mRNA vaccines (e.g. Pfizer-BioNTech andModerna COVID-19 vaccines) and in the future at least two other vaccines (e.g.Oxford-AstraZeneca) as they are approved and become available. Milk samples will beanalyzed for the presence of antibody to SARS-CoV-2 using the Anti-SARS-CoV-2 ELISA (IgGand IgA). These analyses will be conducted in the Department of Microbiology at SinaiHealth following validation of the procedures in human milk.

KU Leuven

Long-term Effects of COVID-19: a Comparative Cohort Study

Conditions: COVID19

This study is a longitudinal cohort study which investigates the effect of COVID-19 inambulatory care. This study aims to assess the effect of COVID-19 beyond the acute phase,i.e. on long-term symptoms, respiratory and cardiovascular health, use of healthservices, and quality of life.

Kafrelsheikh University

Investigating the Potential Role of Aerosolized Retinoic Acid, a Potent Vitamin A Metabolite for Treating COVID-19 Anosmia and Retinoic Acid Insufficiency .A Novel Approach for Regaining Sense of Smell.

Conditions: Post COVID-19 Anosmia (Loss of Smell)

Investigating the potential role of Aerosolized retinoic acid, a potent Vitamin Ametabolite for treating COVID-19 Anosmia and retinoic acid insufficiency .A novelapproach for regaining Sense of Smell.Mahmoud ELkazzaz(1),Tamer Haydara(2), Abedelaziz Elsayed(3) ,Yousry Abo-amer(4), HeshamAttia(5), Quan Liu(6) and Amr Ahmed(7) 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 Pharmaceutical Biotechnology, Faculty of Pharmacy, Tanta University, Egypt. 4. Hepatology,Gastroenterology and Infectious Diseases Department, Mahala Hepatology Teaching Hospital, Egypt 5. Department of Immunology and Parasitology, Faculty of Science, Cairo University, Egypt. 6. 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. 7. Director of tuberculosis program Ghubera, public health department ,First health cluster ,Ministry of health ,Saudia Arabia. - Very important Note: This clinical study is the first clinical study in literature (First posted August 12, 2021) which demonstrated depending on molecular findings that Vitamin A /Retinoic Acid will treat smell loss resulted by COVID-19Recent rapidly accumulating evidences and reports indicate that partial loss of the senseof smell or even total anosmia are early markers of SARS-CoV-2 infection and frequentlyreported symptoms associated with the COVID-19 pandemic (Lechien J. R et al., 2020)However, the cellular mechanisms of this phenomenon are unknown. The rates of insomniaand depression were 26.45% and 9.92% in the COVID-19 patients after recovery. Therefore,finding an effective treatment for COVID-19 Anosmia is a critical point. Although, ACE2has been identified as the principal host cell receptor of 2019-nCoV, and it is thoughtto play a critical role in the virus's entrance into the cell and subsequent infection,many cells can be infected by COVID-19 while also expressing little or no ACE2. Eventhough the COVID-19 entry receptor, angiotensin-converting enzyme 2 (ACE2), is notexpressed in the receptor of olfactory neurons, or its synthesis is limited to to a minorfraction of these neurons.of these neurons, COVID-19 infection causes a loss of smell(anosmia) (Katarzyna Bilinska et al.,2021). Our recent findings showed that COVID-19binds directly to STRA6 receptors of retinol leading to retinol depletion and retinoicacid insufficiency (M Elkazzaz et al,. 2021) . Retinoic acid insufficiency in theolfactory epithelium, both in mouse and chick models, causes progenitor cell maintenancefailure and, consequently, olfactory neurons differentiation is not maintained . Anexplant system, showed that renewal of olfactory neurons is inhibited if retinoic acidsynthesis was failed in the olfactory epithelium (Paschaki M et al., 2013) . It's worthnoting that vitamin A shortage also causes olfactory and taste problems, In a study byGarrett-Laster et al., (1984), the patients had vitamin A deficiency because ofmalnutrition and alcoholic liver cirrhosis; they lost their sense of smell after thatdisorder. LaMantia and Rawson et al.,( 2007) reported that administration of retinoidacid after the damage of olfactory system motivates an immune response and produces amore quick recovery of olfactoryguided behavior. It was showed that Isotretinoin improvedthe significantly performance of patients in the olfactory test(Demet Kartal et al.,2017)Moreover, there is increasing evidence that retinoic acid (atRA) influences geneexpression of components of renin-angiotensin system (RAS), which plays a pivotal role inthe pathophysiology of essential hypertension. Retinoic acid induced ACE2 expression indifferent animal models. Moreover, a study suggests that topical retinoids may haveapplicability in promoting sinus regeneration and wound healing. In a study comparingtreated and untreated nasal mucosa ,untreated regenerated mucosa showed expected changesof submucosal gland loss, basal lamina and lamina propria fibrosis and loss of cilia.Reinoic acid treatment appeared to result in better mucosal regeneration marked by lesscellular atypia and fibrosis(Mendy S. Maccabee et al,. 2003).. Aerosolized retinoic acidwill have an effective role in treating post COVID-19 anosmia (loss of smell) viaupregulating ACE2, STRA 6 and regenerating of olfactory receptors and olfactory sensorycells and neurons.

Istanbul Gelisim University

Aerobic Versus Anaerobic Exercise on Immune Functions and Disease Severity in Patients With COVID-19

Conditions: COVID19, Immune Response

Participants were assigned randomly into two groups, aerobic exercise and resistanceexercise groups. All participants in both groups followed the WHO guidelines ofquarantine and used standardized medications given by the physician according to theTurkish Ministry of Health guidelines, including the Hydroxyclorocin Sulphate 200 Mg FilmTablet (Plaquenil 200 Mg Film Tablet). The dose was 2 times/ day, 200Mg/time, for 5 days.Besides, the aerobic exercise group performed moderate-intensity aerobic exercises for 40min/ 3 sessions/week, 40 minute/session, and the resistance exercise groups 40 min/ 3sessions/week, 40 minute/session.

Saglik Bilimleri Universitesi

PAI-1 Levels and Predicting Covid-19 Patients' Prognosis

Conditions: Covid-19 Positivity Confirmed With PCR Positivity in the Nasopharyngeal Swab, Symptomatic Covid -19 Positive Patients Who Require Hospitalization, Patients Who Did Not Vaccinate Against Covid-19, Patients Among 20 to 90 Years of Age, Healthy Control Patients of the Same Age

The primary aim of our study is to understand the effects of Covid-19 disease on vascularinflammation and coagulation cascade, and secondarily, to investigate its utility inpredicting disease prognosis by analyzing serum PAI-1 levels in patients with differentseverity. The study is planned as a prospective, cross-sectional study that will includepatients admitted to Covid-19 services between January 18, 2021, and August 30, 2021. Atotal of 80 volunteers will be enrolled in the trial whose age, gender, and BMI areplanned to be matched.The study will be conducted on four groups. Group 1 (n=20; withmild symptoms), Group 2 (n=20; with moderate symptoms), Group 3 (n=20; with severesymptoms) and Group 4 (n=20; Control group).All participants who accepted the study will have their sociodemographic data, medicalhistory, and vital signs (respiratory rate, saturation, temperature, and blood pressurevalues) recorded at the start of the study. The pulmonologist in the study will alsoclassify the patient group's chest X-ray and chest tomography findings and the thymusgland dimensions. After all four groups of patients have given their consent for thestudy, a sample of 5cc blood will be obtained once for the PAI-1 analysis.

Universita di Verona

RESPOND: Improving the Preparedness of Health Systems to Reduce Mental Health and Psychosocial Concerns Resulting From the COVID-19 Pandemic

Conditions: Psychological Distress

This randomized controlled trial will evaluate the implementation and(cost-)effectiveness of the culturally and contextually adapted Doing What Matters intimes of stress (DWM) and Problem Management Plus (PM+) stepped-care programs amongstasylum seekers, refugees, and/or migrants living in Italy. Outcomes include mentalhealth, resilience, wellbeing, health inequalities, and costs to health systems.

Afyonkarahisar Health Sciences University

Pain, Fatigue and Life Quality in COVID-19 Patients

Conditions: COVID-19 Pneumonia, Pain, Fatigue, Quality of Life

The aim in this study is to evaluate pain, fatigue and quality of life in patients withCovid-19 pneumonia in long-term follow-up and to investigate their relationship withpneumonia severity, age, presence of comorbidity and depression level.

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Status

  • Unknown status (76)
  • Recruiting (48)
  • Active, not recruiting (27)
  • Not yet recruiting (5)
  • Enrolling by invitation (3)

Intervention Type

  • (-) Other (159)
  • Drug (17)
  • Biological (15)
  • Behavioral (6)
  • Diagnostic Test (6)
  • Procedure (4)
  • Dietary Supplement (1)
  • Radiation (1)

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