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 10 of 25Medical University of Graz
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.
National Institute of Mental Health (NIMH)
People have had to make a lot of changes to their lives due to the COVID-19 healthcrisis. Most experts agree that social distancing and other safety measures have taken atoll on people s mental health. Amish and Mennonite communities often have largefamilies. They may have limited access to health care. Their lifestyle is based oninteraction and group events rather than technology. So people in Amish and Mennonitecommunities may experience the pandemic in their own special ways.Objective:To describe the relationship between stress related to the pandemic and self-ratedmeasures of mental health symptoms and distress among Amish and Mennonite people withbipolar disorder and related conditions, and their family members.Eligibility:Adults ages 18 and older who are taking part in the NIMH AMBiGen study (80-M-0083).Design:Participants will be mailed 4 surveys. One survey will ask about depression symptoms. Onesurvey will ask about mania symptoms. One survey will assess a broad range ofpsychological problems. One survey will assess the impact of COVID-19 on their mentalhealth. They will fill out the surveys 4 times over 24 months.The surveys will not include participants names, just codes. This will help protectprivacy.Data collected in 80-M-0083 will be used. This includes data about participants genes,medical conditions, and assessments.Participants will get an 800 number they can call to speak to the research team. They canalso write to the team if they prefer. Participants who wish will get referrals formental health services. Participation will last up to 24 months. There will be an optionfor recontact in the future.
GI Alliance
The aim of this study is to determine the impact of systemic immunosuppression onsustained antibody COVID-19 concentrations in patients with IBD who received a COVID-19vaccine.
University of Minnesota
Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patientson mechanical ventilation.
Johns Hopkins University
The investigators aim to deliver a tele-wellness supported app to Baltimore City's FamilyChild Care Home (FCCH) providers who are caring for children of Essential Personnel. Oncea pre-survey is conducted, login information will be assigned to 30 Family Child CareHome providers and parents the FCCH serve. Providers and Parents will receive self-careand parenting/parent engagement support through the app and through a tele-wellnessservice, Ask a Nurse, provided by community health nurses at the Johns Hopkins School ofNursing. Children will have access to gamified learning materials in early literacy,math, social-emotional learning, and nutrition.
Baylx Inc.
This is a phase 1/2a study including 2 parts, phase 1 and phase 2a. The phase 1 part isan open-label, single-arm, dose-escalating study to evaluate the safety and explore thedose limiting toxicity and maximum tolerated dose of a human umbilical cord derivedmesenchymal stem cell product (BX-U001) in severe COVID-19 pneumonia patients with acuterespiratory distress syndrome (ARDS). Qualified subjects after the screening will bedivided into low, medium, or high dose groups to receive a single intravenous infusion ofBX-U001 at the dose of 0.5×10^6, 1.0×10^6, or 1.5×10^6 cells/kg of body weight,respectively. The Phase 2a part is a randomized, placebo-controlled, double-blindclinical trial examining the safety and biological effects of BX-U001 at the appropriatedose selected from phase 1 for severe COVID-19 pneumonia patients with the sameinclusion/exclusion criteria as the phase 1 part.
Institut National de la Santé Et de la Recherche Médicale, France
The purpose of this study is to analyze in depth the relationship of myeloid cellsubpopulations during infection by Severe acute respiratory syndrome coronavirus 2(SARS-Cov2), the virus mediating Covid-19. Myeloid cells include neutrophils, monocytesand dendritic cells, each divided into subpopulations with different functions in immunedefense and immune pathologies.The study is based on the following hypotheses: - Infection and the interferon response to infection may induce hyperactive or immunosuppressive differentiation of myeloid cells, that may be treated by specific inhibitors. - Some myeloid cell subpopulations currently identified in our laboratories might be markers for Covid-19 prognosis. - Alternative receptors may be present on myeloid cells, inducing the cytokine storm, a target for therapy. - The expression of Interferon (IFN) receptor and IFN responding genes on myeloid cells and on respiratory epithelial cells may correlate with prognosis and indicate potential treatment targets. - Interferon responses are known to be skewed during Covid-19, but some IFN subtype polymorphisms may correlate with prognosis and these subtypes migt be supplemented or inhibited for therapy.
Sound Pharmaceuticals, Incorporated
The study is a randomized, double-blind, placebo-controlled, dose escalation,multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR testfor novel SARS-CoV-2 (nCoV2) and moderate symptoms of COVID-19 disease.
Sound Pharmaceuticals, Incorporated
The study is a randomized, double-blind, placebo-controlled, dose escalation,multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR testfor novel SARS-CoV-2 (nCoV2) and severe symptoms of COVID-19 disease.
Celltex Therapeutics Corporation
This is a phase 2 multi-center, double-blind, randomized, placebo-control clinical trialwith 200 subjects who have never been infected by COVID-19 (SARS-Cov-2 virus screen testnegative, no blood SARS-Cov-2 IgM and IgG antibodies detected during enrollment) followedby a pilot study of 5 subjects to demonstrate the safety of proposed three-dose regimenof autologous AdMSCs infusions. The 100 study subjects who have previously banked theirAdMSCs with Celltex, will receive three doses of autologous AdMSCs (approximately 200million cells) intravenous infusion every three days. The 100 subjects in the controlgroup who have previously banked their AdMSCs with Celltex will not receive any Celltex'sAdMSC therapy but placebo treatments. All subjects are monitored for safety (adverseevents/severe adverse events), COVID-19 symptoms, SARS-Cov-2 virus test, blood SARS-Cov-2IgM and IgG antibodies tests, blood cytokine and inflammatory (CRP, IL_6, IL-10, TNFα)tests and disease severity evaluation for 6 months after the last dose of AdMSC infusionfor the study group and 6 months after the enrollment for the control group.