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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 110 of 116University of Arizona
Conditions: COVID-19 Respiratory Infection, Influenza
Viruses are a major health problem for the general public and at risk populations.Normally, detection of antibody titers is the gold standard for determining theeffectiveness of the immune system following natural or vaccine caused immunization.However, determining the effectiveness of other parts of the immune system are lesscommon due to the difficulties with testing. Furthermore, there is a critical need toaddress other therapies in case vaccination is not successful in immuncompromisedpopulations. Exercise has been shown to increase the strength of the immune systemagainst many types of viruses and therefore could be simple way to improve immunityagainst the COVID-19 virus. The aim of this research is to determine the effects ofexercise on anti-viral immunity against many types of common viruses before and aftervaccination. We hypothesize that exercise will enhance the anti-viral immunity before andafter vaccination.Up to 30 healthy volunteers (age 18-44 years) will be recruited to participate in thisstudy. For completion of Aim 1, three visits are needed totaling around 7 hours of thepatient's time and for Aim 2, three visits are needed totaling around 4.5 hours of thepatient's time. The initial visit will be for pre-screening and if deemed healthy enoughto participate, an exercise test to determine the VO2 max of the participant will beconducted. The following visits will require a trained phlebotomist to insert anin-dwelling catheter and participants will undergo a 20-minute incremental exercisetrial. Approximately 50mL of blood will be collected at four different timepoints: atrest, 60% VO2 max, 80% VO2 max, and 1-hr post-exercise. All four collected blood sampleswill be used to expand viral specific T-cells and compare IFN-γ rele
Universitätsklinikum Köln
Conditions: Cystic Fibrosis
Coronavirus disease 2019 (COVID-19) which is caused by the virus Severe Acute RespiratorySyndrome Coronavirus-2 (SARS-CoV-2) has resulted in an ongoing global pandemic. It isunclear whether the relatively low number of reported cases of COVID-19 in people with CF(pwCF) is due to enhanced infection prevention practices or whether pwCF have protectivegenetic/immune factors. This study aims to prospectively assess the proportion of pwCF,including both adults and children with CF who have evidence of SARS-CoV-2 antibodiesover a two-year period. This study will also examine whether pwCF who have antibodies forSARS-CoV-2 have a different clinical presentation and what impact this has on their CFdisease. The proposed study will recruit pwCF from paediatric and adult CF centresthroughout the United Kingdom. Serological testing to detect antibodies will be performedon blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points ifbloodwork is available via normal clinical care. Clinical data on, lung function,CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology andvaccination receipt, will be collected during routine clinical assessments.Associations will be examined between socio-demographic and clinical variables andserologic testing. The investigators will also examine the effects of SARS-CoV-2infection on clinical outcomes and analyse end-points to explore any age-related orgender-based differences, as well as subgroup analysis of outcomes in lung-transplantrecipients and pwCF receiving cystic fibrosis transmembrane conductance regulator (CFTR)modulator therapies. As pwCF receive COVID-19 vaccination the investigators will performa comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCFfollowing natural infection and vaccination SARS-CoV-2 over time.
Imperial College London
Conditions: COVID19, SARS-CoV-2 Infection
This study will test the COVID-19 vaccine candidate AZD1222 to investigate its safety,tolerability and capability of boosting immune responses both in the blood and the lungwhen administered to the respiratory tract, in volunteers previously vaccinated byintramuscular COVID-19 vaccination. Using standardised methods, we will measure immuneresponses in the blood, nose and lower airway and compare with data from ongoing clinicaltrials of intramuscular vaccination. Thus, we will show the effect of the delivery methodand provide the critical information required to begin further clinical trials to showthe efficacy of this needle-free vaccination strategy for booster vaccination.
International AIDS Vaccine Initiative
Conditions: HIV
A Phase 1, Randomized, First-in-human, Open-label Study to Evaluate the Safety andImmunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNAVaccine (mRNA-1644v2-Core) in HIV-1 Uninfected Adults in Good General Health
International Vaccine Institute
Conditions: COVID19
This is an observer-blind, randomized study which aims to assess the immune response andthe safety of two different approved vaccines for first and second dose in healthyadults.
Vastra Gotaland Region
Conditions: Cystic Fibrosis, COVID19
Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resultedin an ongoing global pandemic. It is unclear whether the relatively low number ofreported cases of COVID-19 in people with CF (pwCF) is due to enhanced infectionprevention practices or whether pwCF have protective genetic/immune factors. This studyaims to prospectively assess the proportion of pwCF, including both adults and childrenwith CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This studywill also examine whether pwCF who have antibodies for SARS-CoV-2 have a differentclinical presentation and what impact this has on their CF disease. The proposed studywill recruit pwCF from paediatric and adult CF centres in Europe. Serological testing todetect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24with additional time-points if bloodwork is available via normal clinical care. Clinicaldata on, lung function, CF-related medical history, pulmonary exacerbations, antibioticuse, and microbiology and vaccination receipt, will be collected during routine clinicalassessments.Associations will be examined between socio-demographic and clinical variables andserologic testing. We will also examine the effects of SARS-CoV-2 infection on clinicaloutcomes and analyse end-points to explore any age-related or gender-based differences,as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receivingCFTR modulator therapies. As pwCF receive COVID-19 vaccination we will perform acomparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCFfollowing natural infection and vaccination SARS-CoV-2 over time.
Walvax Biotechnology Co., Ltd.
Conditions: COVID-19
The purpose of this double-blind, randomized, controlled study is to assessimmunogenicity and safety of 202-CoV at multiple dose levels, administered as 2injections (i.m) at 28 days apart in adult subjects 18 years of age and above.
ResApp Health Limited
Conditions: COVID19
Decentralized clinical study designed to collect further cough sounds, self-reportedsymptoms, and medical treatment questionnaires from participants enrolled on theCOVID-Cough Study ("Study 1").The aim of this further data collection study ("Study 2") is to: 1. develop an understanding of changes in cough sounds associated with COVID-19 and how they alter during the disease; 2. develop an understanding of other causes of COVID-19-like symptoms and their associated cough sound patterns; and 3. gain a broader understanding of the clinical outcomes of individuals who present for COVID-19 testing.
Hôpital Européen Marseille
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2, Acute Respiratory Distress Syndrome, Pulmonary Fibrosis
The COVID-19 pandemic is caused by the severe acute respiratory syndrome coronavirus 2(SARS CoV-2), an emerging coronavirus, which has already infected 192 million people witha case fatality rate close to 2%. About 5% of patients infected with SARS CoV-2 have acritical form with organ failure. Among critical patients admitted to intensive care,about 70% of them will require ventilatory assistance by invasive mechanical ventilation(MV) with a mortality rate of 35% and a median MV duration of 12 days. The most severelung damage resulting from SARS CoV-2 infection is the acute respiratory distresssyndrome (ARDS). The virus infects alveolar epithelial cells and capillary endothelialcells leading to an activation of endothelium, hypercoagulability and thrombosis ofpulmonary capillaries. This results in abnormal ventilation / perfusion ratios andprofound hypoxemia. To date, the therapeutic management of severe SARS CoV-2 pneumonialay on the early use of corticosteroids and Interleukin-6 (IL-6) receptor antagonist,which both reduce the need of MV and mortality. The risk factors of death in IntensiveCare Unit (ICU) are: advanced age, severe obesity, coronary heart disease, active cancer,severe hypoxemia, and hepatic and renal failure on admission. Among MV patients, thedeath rate is doubled in those with both reduced thoracopulmonary compliance and elevatedD-dimer levels. Patients with severe alveolar damage are at risk of progressing towardsirreversible pulmonary fibrosis, the incidence of which still remain unknown. Thediagnosis of pulmonary fibrosis is based on histology but there are some non-invasivealternative methods (serum or bronchoalveolar biomarkers, chest CT scan). We aim toassess the incidence of pulmonary fibrosis in patients with severe SARS CoV-2 relatedpneumonia. We will investigate the prognostic impact of fibrosis on mortality and thenumber of days alive free from MV at Day 90. Finally, we aim to identify risk factors offibrosis.
Walvax Biotechnology Co., Ltd.
Conditions: COVID-19
The purpose of this double-blind, randomized, controlled study is to assess safety,reactogenicity, and preliminary immunogenicity of 202-CoV at multiple dose levels,administered as 2 injections (i.m) at 28 days apart in adult subjects 18 years of age andabove.