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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Displaying 70 of 270Green Cross Corporation
The objective of this study is to evaluate the efficacy and safety of 5131A for hospitalized patients of COVID-19.
Telethon Kids Institute
In recent months severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) has emerged as a novel human pathogen and, susceptibility amongst humans is presumed to be universal. Prevention measures of COVID-19 have included distancing, quarantines, use of facemasks in public places, and hand hygiene measures. Mandatory quarantines have also been applied on index cases and their contacts, as well as an active search for asymptomatic patients. Current strategies to reduce the spread of SARS-CoV-2 do not include measures that could prevent transmission prior to the onset of symptoms. Subjects infected with SARS-CoV-2 have been known to shed virus and be contagious for up to 5 days prior to developing symptoms ('pre-symptomatic transmission'). In fact, nearly 60% of all infected subjects can shed virus pre-symptomatically. Pre- or even asymptomatic shedding occurs across all age groups, contributing to the rapidly expanding pandemic. Post-exposure prophylaxis (PEP) using type 1 interferon (IFN) can potentially eliminate the spread of SARS-CoV-2. IFN could reduce the period of viral shedding by ~1 week. Since pre-symptomatic shedding of virus can start up to 5 days prior to symptom onset, our approach of a PEP intervention to all contacts recently exposed to a case could possibly entirely interrupt the spread of the virus, and with that, the pandemic. The current study focuses on prevention of the disease in addition to its treatment. Thus, the key distinction between these other trials and this study is that this study focuses on containing coronavirus (i.e. cause) in the community, rather than simply its treatment (i.e. consequence) in the individual. Viral spread could be eliminated through interventions effective at abolishing viral transmission. However, such post-exposure prophylaxis interventions, that is initiation of antiviral therapy in pre-infectious contacts to reduce or even eliminate such spread, must be safe since they are given to asymptomatic and possibly uninfected subjects. In none of the previous clinical trials of IFN therapy for SARS-CoV-2 have serious adverse events been recorded. Furthermore, the IFN chosen for this study (pegylated IFN 1b) has been extensively studied in clinical trials, and has been in clinical use for years for multiple sclerosis. Pegylated IFN formulations allow for weekly injections while maintaining serum levels and limiting dose-dependent side effects. Together these data support a sound safety profile for the planned intervention. The aim of this study is to ascertain whether IFN administered to index cases and household contacts of an index case, starting immediately following confirmed exposure (index case confirmed positive for SARS-CoV-2), will reduce duration of SARS-CoV-2 detectable by PCR in the index cases, and incidence of SARS-CoV-2 detectable by PCR in household contacts.
CHU de Reims
Medical context: Follow-up of a retrospective cohort of 499 cases of CoViD-19, hospitalized at the University Hospital of Reims during the health crisis, prospectively up to two years of follow-up. Possible intervention for serological monitoring, leading to a change from category 3 to category 2 (French law on human person research) Aim of the study: To know the factors of gravity of CoViD-19, to know its prognostic factors, to see how the evolution of the treatments implemented have influenced the fate of the patients. Material and methods: Type of study: cohort study Population: Patients in the CoViD-19 cohort - Reims Calendar: September 2020 - July 2022 Expected results: Better knowledge of the cares of patients with CoViD-19
Zhongnan Hospital
This is a clinical trial to evaluate the safety and immunogenicity of a recombinant adenovirus 5 vectored COVID-19 vaccine (Ad5-nCoV) with two doses and with different adminstration routes in healthy adults aged 18 years and older.
Kamada, Ltd.
Evaluate the safety pharmacokinetics and pharmacodynamics (PK/PD)of a single dose of Kamada anti-severe acute respiratory syndrome (SARS)- CoV-2 in patients hospitalized with COVID-19 caused pneumonia
Instituto Grifols, S.A.
The purpose of the study is to determine if Convalescent anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Methylene Blue Treated (MBT) plasma plus Standard Medical Treatment (SMT) can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the intensive care unit (ICU) through Day 29.
University of Minnesota
This protocol will serve as a platform for assessing treatments for adult patients hospitalized for medical management of COVID-19 without related serious end-organ failure. Trials will involve sites around the world strategically chosen to ensure rapid enrollment. This trial will compare hyperimmune intravenous immunoglobulin (hIVIG) with matched placebo, when added to standard of care (SOC), for preventing further disease progression and mortality related to COVID-19. SOC will include remdesivir unless it is contraindicated for an individual patient.
University Hospital Tuebingen
Safety and Immunogenicity Trial of Multi-peptide Vaccination to Prevent COVID-19 Infection in Adults
Part I: 12 subjects will receive an open-label 500 µl subcutaneous injection via needle and syringe of the study IMP (CoVac-1). No more than one subject per day will be enrolled. 28 days following vaccination of the 12th volunteer, there will be an interim analysis of safety and a safety review by the data safety monitoring board (DSMB) as well as an amendment to the regulatory authorities (Paul-Ehrlich Institute and Ethics Committee) before proceeding to Part II. Part II: 12 subjects will receive an open-label 500 µl subcutaneous injection via needle and syringe of the study investigational medicinal product (IMP) (CoVac-1). 28 days following vaccination of the 12th volunteer, there will be an interim analysis of safety and a safety review by the DSMB whether to proceed to next Part III. Part III: 12 subjects will receive an open-label 500 µl subcutaneous injection via needle and syringe of the study IMP (CoVac-1). The aim of the clinical is to evaluate the safety and immunogenicity of a single use of a SARS-CoV-2-derived multi-peptide vaccine in combination with the toll like receptor (TLR)1/2 ligand XS15 in adults
Hospital de Clinicas de Porto Alegre
Plasma, the supernatant part of blood, contains a variety of different proteins, including immunoglobulins. These proteins, also called antibodies, are directed to previous foreign infecting organisms, such as virus, bacteria or parasites. Patients recovering from SARS-Cov-2 infection may develop protective antibodies which can prevent reinfection with the same agent or similar organisms with shared molecular structures. Those antibodies may be transferred to other patients through collection of such convalescent plasma from recovered donors and its transfusion to ill patients. In this research, the primary hypothesis is that those antibodies can exert passive immunization and help ameliorate symptoms from COVID-19 (Coronavirus Disease 2019), resulting in higher clinical improvement rates at day 28, especially when administered early in the infection course.
Vaxxinity, Inc.
This is a phase I, open-label, dose-escalation clinical study to evaluate the safety, tolerability and immunogenicity of 3 ascending doses of UB-612 COVID-19 vaccine in healthy adults, aged from 20 to 55 years old.