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. If you do not find a satisfactory expanded access program here, please search in our COVID Company Directory. Some companies consider expanded access requests for single patients, even if they do not show an active expanded access listing in this database. Please contact the company directly to explore the possibility of expanded access.
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.
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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 360 of 370Instituto de Investigación Marqués de Valdecilla
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.
CytoDyn, Inc.
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.
ClarData
The aim of the project is to better understand the Covid-19 inpatient course of thedisease and to quickly identify the positive experiences in the treatment in order toupdate guidelines for the treatment and use of medication.
Direction Centrale du Service de Santé des Armées
Several patients with hypoxaemic SARS-CoV2 pneumonia were able to benefit from hyperbaricoxygen treatment (HBOT) in China. In a clinical case published in the Chinese journal ofhyperbaric medicine, treatment with repeated HBO sessions prevented admission tointensive care unit with mechanical ventilation in a patient aged 69 who presented withsigns of respiratory decompensation. HBOT is the most powerful oxygenation modality inthe body today. HBOT can dramatically increase the amount of dissolved oxygen in theblood. HBOT not only promotes blood transport but also its tissue delivery. Furthermore,HBOT has specific immunomodulatory properties, both humoral and cellular, making itpossible, for example, to reduce the intensity of the inflammatory response and tostimulate antioxidant defenses by repeating sessions. A virucidal capacity of HBOT mightalso be involved. HBOT is generally regarded as safe with very few adverse events.Following this feedback, it is proposed in the context of crisis management related toSARS-CoV2 to assess the value of HBO treatment of patients with CoV2 pneumonia. Indeed,it seems essential to propose therapeutic strategies to limit the risk of respiratorydecompensation requiring admission to intensive care unit for patients with SARS-CoV2pneumonia.
Tongji Hospital
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.
Hospital General Universitario Morales Meseguer
Evaluate HACOR socre utility and efficacy in predicting NIV and/or CPAP failure inpatients with COVID-19 associated respiratory failure.Propose adaptations to HACOR score based on the "state of art" of COVID-19
University of Karachi
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.
Hospices Civils de Lyon
Covid-SER is a prospective multi-center study for the evaluation of diagnosticperformance of available serological tests
Institut National de la Santé Et de la Recherche Médicale, France
Infectious disease is the single biggest cause of death worldwide. New infectious agents,such as the SARS, MERS and other novel coronavirus, novel influenza viruses, virusescausing viral haemorrhagic fever (e.g. Ebola), and viruses that affect the centralnervous system (CNS) such as TBEV & Nipah require investigation to understand pathogenbiology and pathogenesis in the host. Even for known infections, resistance toantimicrobial therapies is widespread, and treatments to control potentially deleterioushost responses are lacking.In order to develop a mechanistic understanding of disease processes, such that riskfactors for severe illness can be identified and treatments can be developed, it isnecessary to understand pathogen characteristics associated with virulence, thereplication dynamics and in-host evolution of the pathogen, the dynamics of the hostresponse, the pharmacology of antimicrobial or host-directed therapies, the transmissiondynamics, and factors underlying individual susceptibility.The work proposed here may require sampling that will not immediately benefit theparticipants. It may also require analysis of the host genome, which may reveal otherinformation about disease susceptibility or other aspects of health status.
Sanofi
Primary Objectives: - Safety run-in Part: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) - Randomized Phase 3 Part: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMMSecondary Objectives:Safety run-in Part: - To assess overall response rate (ORR) - To assess duration of response (DOR) - To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR) - To assess time to diagnostic (SLiM CRAB) progression or death - To assess time to first-line treatment for multiple myeloma (MM) - To assess the potential immunogenicity of isatuximab - Impact of abnormal chromosomal subtype on participant outcomeRandomized Phase 3 Part:Key Secondary Objectives:To compare between the arms - MRD negativity - Sustained MRD negativity - Second progression-free survival (PFS2) - Overall survivalOther Secondary Objectives:To evaluate in both arms - CR rate - ORR - DOR - Time to diagnostic (SLiM CRAB) progression - Time to biochemical progression - Time to first-line treatment for MM - Impact of abnormal chromosomal subtype on participant outcome - Safety and tolerability - Pharmacokinetics (PK) - Potential of isatuximab immunogenicity - Clinical outcome assessments (COAs)