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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 35BioClever 2005 S.L.
Conditions: COVID-19
The purpose of the study is to confirm if BACTEK-R (MV130) provides clinical benefit insubject with mild pneumonia (CURB-65≤2) by COVID-19 admitted to the Hospital.
Celularity Incorporated
Conditions: Coronavirus, Coronavirus Infection, Severe Acute Respiratory Syndrome Coronavirus 2, Pneumonia, Pneumonia, Viral, Lung Diseases, Respiratory Tract Disease, Respiratory Tract Infections, Coronaviridae Infections, Nidovirales Infections, RNA Virus Infections, Virus Disease, Immunologic Disease, ARDS, Immunologic Factors, Physiological Effects of Drugs, Antiviral Agents, Anti-infective Agents, Analgesics, Antimetabolites, Antineoplastic
This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, animmunotherapy containing Natural Killer (NK) cells derived from human placental CD34+cells and culture-expanded, in patients with moderate COVID-19 disease.
Healios K.K.
Conditions: ARDS
Multicenter investigation featuring an open-label lead-in followed by a double blinded,randomized, placebo-controlled Phase 2/3 part to evaluate the safety and efficacy ofMultiStem therapy in subjects with moderate to severe Acute Respiratory Distress Syndrome(ARDS) due to pathogens including COVID-19.
University Hospital Tuebingen
Conditions: ARDS, COVID-19
To evaluate the safety, toxicity and immunological effects of infusion of allogeneic bonemarrow-derived human mesenchymal stem (stromal) cells (MSCs) and whether this therapy hasan influence on the resolution processes in ARDS patients infected with Severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2).
BioMérieux
Conditions: Intensive Care Unit, SARS-CoV-2
Infection with the SARS-CoV-2 coronavirus (COVID-19) has recently been identified as apandemic due to the speed and global scale of its transmission. In Auvergne-Rhône-Alpesregion (AURA), the epidemic began in February 2020 and the number of infected people isstill important. Between 15 and 20% of COVID-19 patients develop an acute respiratorydistress syndrome (ARDS) leading to their hospitalization in intensive care. Theirclinical progression can be rapidly harmful with the development of severe ARDSassociated with an increased risk of death.Preliminary data on the immune response of COVID-19 patients describe the induction of amoderate inflammatory response and the occurrence of major progressive lymphopenia overtime associated with potential immunosuppression. Up to 50% of secondary infections arereported in deceased COVID-19 patients. However, no prospective study has exhaustivelydescribed the kinetics of the immune response of COVID-19 patients in intensive care.The precise description of the immune response over time in adult patients with a proveninfection with the SARS-CoV-2 virus and the study of the relation between this responseand the increased risk of organ failure (severe ARDS), death or nosocomial infection willallow us to better understand the pathophysiology of the immune response induced byCOVID-19 in order to (i) identify new therapeutic strategies targeting the host responsein patients in intensive care (ii) to develop biological markers to stratify patients forfuture clinical trials evaluating these immunoadjuvant treatments in COVID-19.
SAb Biotherapeutics, Inc.
Conditions: COVID-19, SARS-COV2
: Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developedSAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic [Tc]bovine-derived), as a potential therapeutic to treat COVID-19. This study will evaluatethe safety, immunogenicity, and pharmacokinetics of SAB-185 in ambulatory participantswith COVID-19.
University of California, Los Angeles
Conditions: Corona Virus Infection
This study will provide access to investigational anti-SARS-CoV-2 human convalescentplasma for pediatric patients with underlying medical conditions (cardiovascular disease,lung disease, immunosuppression) who are either infected with SARS-CoV-2 or who have hada high-risk exposure. Study participants will be transfused once with compatibleconvalescent plasma obtained from an individual who has recovered from documentedinfection with SARS-CoV-2. Safety information and pharmacokinetic data will be collected.
Sentien Biotechnologies, Inc.
Conditions: COVID-19, Acute Kidney Injury, Sepsis
The purpose of this study is to assess the safety and tolerability of the investigationalproduct, SBI-101, in subjects with an infectious etiology of Acute Kidney Injury (AKI).SBI-101 is a biologic/device combination product designed to regulate inflammation andpromote repair of injured tissue using allogeneic human mesenchymal stromal cells.SBI-101 will be integrated into the renal replacement circuit and patients will betreated for up to 24 hours.
Bandim Health Project
Conditions: Poliovirus Vaccine, Oral, COVID, Mortality, Morbidity, Non-specific Effects of Vaccines
Since the 1960s, studies have shown that oral polio vaccine (OPV) may have beneficialnon-specific effects, reducing morbidity and mortality from other infections than polio.Such beneficial non-specific effect have been observed for other live vaccines, includingmeasles, smallpox and BCG vaccine. For BCG, the vaccine for which the mechanism has beenstudied the most, the effects appear to be mediated through the innate immune system. TheCOVID-19 pandemic caused by the novel coronavirus SARS-CoV-2 has now caused over 7.1million cases and >400,000 deaths worldwide. As everywhere else, it is anticipated thatin Africa the older part of the population will be at risk of severe COVID-19. OPV iswidely used in Africa, but for children. Both polio and coronavirus are positive-strandRNA viruses, therefore it is likely that they may induce and be affected by common innateimmune mechanisms.In a randomised trial at the Bandim Health Project in Guinea-Bissau, the investigatorswill assess the effect of providing OPV vs no vaccine to 3400 persons above 50 years ofage. The trial will have the power to test the hypothesis that OPV reduces the combinedrisk of morbidity admission or death (composite outcome) by at least 28% over thesubsequent 6 months.
Centre Hospitalier Universitaire, Amiens
Conditions: COVID19, TSH, Cortisol
The data obtained from Covid-19 infections seem to suggest that the immunogenesis ofCovid-19 could in some cases be the result of immune dysregulation. On the other hand,endocrine damage is possible at the tile of Covid-19 infection (mainly thyroid,adrenal,and hypothalamus). These disorders are autoimmune or linked to degeneration.The main objective is to assess the thyroid function (thyrotropic axis) as well as thecorticotropic adrenal function of patients who have had Copvid-19 pneumonia. Thesecondary objectives is to describe the pathophysiological mechanisms of pulmonary andvasculothrombotic involvement of Covid-19