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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 90 of 134

Medical University of Graz

Effects of COVID-19 on Endothelium in HIV-Positive Patients in Sub-Saharan Africa

Conditions: COVID19, HIV, ART

Background: Coronavirus disease 2019 (COVID-19) has affected almost every country in theworld, especially in terms of health system capacity and economic burden. People fromsub-Saharan Africa (SSA) often face interaction between human immunodeficiency virus(HIV) infection and non-communicable diseases such as cardiovascular disease. Role of HIVinfection and anti-retroviral treatment (ART) in altered cardiovascular risk isquestionable and there is still need to further carry out research in this field.However, thus far it is unclear, what impact the COVID-19 co-infection in people livingwith HIV (PLHIV), with or without therapy will have. The ENDOCOVID project aims toinvestigate whether and how HIV-infection in COVID-19 patients modulates the time courseof the disease, alters cardiovascular risk, and changes vascular endothelial function andcoagulation parameters/ thrombosis risk.Methods: In this long-term study, cardiovascular research on PLHIV with or without ARTwith COVID-19 and HIV-negative with COVID-19 will be carried out via clinical andbiochemical measurements for cardiovascular risk factors and biomarkers of cardiovasculardisease (CVD). Vascular and endothelial function will be measured by brachial arteryflow-mediated dilatation (FMD), carotid intima-media thickness (IMT) assessments, andretinal blood vessel analyses, along with vascular endothelial biomarkers andcoagualation markers. The correlation between HIV-infection in COVID-19 PLHIV with orwithout ART and its role in enhancement of cardiovascular risk and endothelialdysfunction will be assessed. Potential changes in these endpoints by COVID-19 will befollowed for 4 weeks across the three groups (PLHIVwith or without ART and HIVnegatives).Impact of project: The ENDOCOVID project aims to evaluate in the long-term thecardiovascular risk and vascular endothelial function in PLHIV thus revealing animportant transitional cardiovascular phenotype in COVID-19.

Reven Pharmaceuticals, Inc.

Tolerability and Efficacy of RJX in Patients With COVID-19

Conditions: COVID-19, Acute Respiratory Distress Syndrome, SARS-CoV-2, Hypoxemia

This study is designed as a 2-part, 2-cohort, double-blind, randomized, placebocontrolled, multicenter Phase 1/2 study to evaluate the safety, tolerability and efficacyof RJX in patients with COVID-19.

Cytocom, Inc.

Single-Blind Study of STAT-205 in Mild COVID-19

Conditions: COVID-19

This is a randomized, single blind, study. Males and females meeting inclusion criteriawho have symptoms of mild COVID-19 and in whom a positive PCR result for SARS-CoV-2 isobtained may be enrolled to the study treatment within 72 hours of the positive PCRresult. Eligible patients are those considered to be at high risk for COVID-19 diseaseprogression. This includes patients ≥ 65 years of age or with any one or more of certainmedical conditions including: cancer, COPD, cardiovascular disease, immunocompromisedstate resulting from solid organ transplant, obesity, sickle cell disease, history ofsmoking, and diabetes.

Kitasato University

Study in COvid-19 Patients With iveRmectin (CORVETTE-01)

Conditions: COVID19

Treatment of mild COVID-19 is basically performed at an outpatient clinic, then when thesymptom and clinical findings exacerbate to a moderate level, patients are admitted.There is no standard treatment for mild cases. This study will investigate whetherivermectin administration suppresses the replication of SARS-CoV-2 in mild to moderateCOVID-19 by investigating the negative rate of SARS-CoV-2 PCR by a randomized controlledtrial. Subjects are assigned to two groups, the placebo group, and the ivermectin group.The target number of each treatment arm is 120, a total of 240 cases. A single oraladministration of 200 ㎍/kg of ivermectin or an ivermectin-free placebo will beadministered on an empty stomach. Time to negativization of SARS-CoV-2 PCR as the primaryendpoint with additional efficacy and safety of the process will be investigated.

Regeneron Pharmaceuticals

Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

Conditions: Chronic Obstructive Pulmonary Disease

Primary Objective:Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acutemoderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPDSecondary Objectives: - Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD - Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD - Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD - Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD

Shin Poong Pharmaceutical Co. Ltd.

The Safety and Efficacy of Pyronaridine-artesunate (Pyramax® or Artecom®)in COVID-19 Patients

Conditions: COVID19

This is a multi-center, randomized, Phase 2/3 study to evaluate the safety and efficacyof pyronaridine-artesunate in participants with corona virus disease 2019 (COVID-19).Pyronaridine-artesunate has been approved in Europe, Asia and Africa under brand name ofPyramax® or Artecom® as a treatment for malaria. The study will be conducted in twostages: open-label (Stage 1) and double-blind (Stage 2).Up to approximately 402 participants (20 participants in Stage 1 and 382 participants inStage 2) are planned to be enrolled in the study and will be randomized to receive eitherArtecom® or matching placebo at a ratio of 1:1 in Stage 2. The dose of Artecom® will bedetermined by the participant's body weight, according to previously establishedguidelines.An independent Drug Safety Monitoring Board (DSMB) will be established to review thesafety at regular intervals during the conduct of the trial. The DSMB will be subject toa Charter and will review after 20 participants have been recruited, and thereafter when191 participants have been recruited.Ad-hoc DSMB meetings may be held at any time during the study if there are any majorsafety concerns. A final DSMB will be conducted when all participants have been recruitedin the trial.

Sheba Medical Center

Synthetic CBD as a Therapy for COVID-19

Conditions: COVID19, CBD

The study aim to test proof of concept of CBD treatment for efficacy and safety inpatients suffering with mild COVID-19 infection. The CBD will be delivered via oildroplets not containing THC, compared to placebo.

Aventyn, Inc.

COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy

Conditions: COVID19

Researchers are creating real-time epidemiology registry to evaluate the efficacy ofCOVID-19 subject risk assessment scores based on recording of symptoms, biomarkers,chronic illness and mental health assessments with digital technology using wearables andmobile app tools. Researchers aim to study in Phase 1, epidemiological variations inCOVID-19 presentation in both PCR positive and negative subjects in the registry.Assessment of variables, predictive modeling of variables that impact severity ofCOVID-19 positive and negative subjects and assessment of predictors for post COVID-19complications. In Phase 2, 2700 subjects with COVID-19 positive test will be studied inthe intervention group comparing ECL-19 vs placebo with primary end point of hospitaladmission assessment. Treatment strategy for PCR positive COVID-19 subjects in theregistry who are in Stage I of the disease process with ECL-19 drug compared to placeboin reducing hospital admissions

Corat Therapeutics Gmbh

Evaluation of Safety and Tolerability of COR-101 in Hospitalized Patients With Moderate to Severe COVID-19

Conditions: COVID19

Primary objectives Part 1: - To evaluate the safety and tolerability of COR-101 compared to placeboSecondary objectives Part 1: - To evaluate the preliminary efficacy of COR-101 compared to placebo in hospitalized patients with moderate to severe COVID-19 - To assess the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of COR-101

University of Kansas Medical Center

Hyperpolarized 129Xe MRI of Survivors of COVID-19

Conditions: COVID19

The purpose of this study is to evaluate pulmonary function of patients recovering frommild, moderate, and severe COVID-19 disease using hyperpolarized 129Xe MRI.

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Status

  • Unknown status (64)
  • Active, not recruiting (37)
  • Recruiting (19)
  • Enrolling by invitation (5)
  • Not yet recruiting (4)
  • Available (3)
  • Approved for marketing (2)

Intervention Type

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

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