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 14Medical 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.
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.
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.
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
During the current pandemic, in Italy the majority of asymptomatic or pauci-symptomaticCOVID-19 cases were not identified nor diagnosed and this fact caused a decrease in theeffectiveness of the various containment measures implemented. Therefore, in a futurescenario where a new viral swarm is expected, the early identification of all infectedcases becomes essential to plan and activate a containment strategy for the spread of thevirus, given the current absence of vaccines.The typical radiological finding of COVID-19 is an interstitial pneumonia, which can beresponsible, in a significant portion of patients, of an acute respiratory distresssyndrome (ARDS).Low-dose chest CT and simple blood tests could identify sub-solid pulmonary nodules(SSNs) indicative of COVID-19 infection in asymptomatic subjects.Objectives of this observational study are the early detection of COVID-19 markersindicative of prior exposure or persisting viral infection in asymptomatic subjects andthe assessment of the frequency and outcome of COVID-19-related SSNs in asymptomaticsubjects by time, domicile, and other individual risk factors.SMILE lung CT screening program cohort has been considered, based on 960 subjects at highlung cancer risk for tobacco smoking (≥20 pack/year) and age (50-75 years), together withinflammatory and respiratory profile. SMILE utilizes a top technology dual-source CTscanner (Somatom Force) with the lowest radiation dose ever applied to lung screening.All chest CT images from screening subjects will be re-evaluated by two additional CADprograms, specifically designed for the analysis of SSNs and quantification of the totalvolume of lung parenchyma showing an increased density. This re-evaluation will improvethe sensitivity and specificity of radiomic assessment.This study cohort, enriched by the already established longitudinal biobank of frozenplasma samples, represent an ideal opportunity to assess the frequency of SSNs inasymptomatic subjects, due to the effect of COVID-19, particularly among subjects livingin areas at high risk of viral exposure. It will also be possible to evaluate ifCOVID-19-related SSNs are associated with chronic co-morbidity, other individual riskfactors, inflammatory (CRP) / immunomodulatory (25(OH)D) blood profile, and/or can betraced by immune markers such as IgM/IgG and other cytokines.Clinical data will be integrated with an analysis of the IgG-IgM profile specific forcovid-19, on the plasma samples taken at the time of the CT scan, or subsequently, incollaboration with University of Milan, Luigi Devoto Work Clinic.The lasting collaboration with the Radiological Science Department of the University ofParma in lung screening also offers the opportunity to validate the results obtained inthis cohort on chest CT performed at the University Parma Hospital during the last twomonths in symptomatic subjects for suspected covid-19 pneumonia.In collaboration with University of Milano Bicocca, Machine Learning (ML) tools will beapplied to predict the clinical relevance, severity and ultimate outcome of SSNs, basedon radiomic CT features, epidemiologic risk, co-morbidity and inflammatory/immune bloodbiomarkers. ML analysis will generate a predictive algorithm for clinical outcome ofSSNs, and specifically the risk of COV-I9 infection and unfavorable disease prognosis.
University of Iowa
In this study, COVID-19 positive patients will be added to a bidirectional textingprogram to receive daily surveys about their symptoms with the infection. This data willfurther the understanding of COVID-19 symptom development throughout the infectionperiod, as well as how those symptoms vary at different points of the day. This studywill be a single cohort, observational study of COVID-19 patients.
Methodist Health System
Electronic medical record review of de-identified patients who tested positive forCOVID-19 (using a PCR test) at Methodist Dallas Medical Center (MDMC) from June 2020until the date of IRB approval. Data will be collected on de-identified patients thattest positive for COVID-19 (using a PCR test) at MDMC from the date of IRB approval untilDecember 2022. Disclaimer: Any cost associated with the procedures stated herein will bebilled directly to you or to your insurance (as applicable)
University of Minnesota
The Professional Peer Resilience Initiative (PPRI) study is an observational study aimedat understanding how symptoms of traumatic stress and resilience evolve over time in theUniversity of Minnesota (UMN) healthcare workforce during the coronavirus disease 2019(COVID-19) pandemic. The study is being conducted concurrently with a UMN peer supportprogram called the MinnRAP program and will remotely administer quality of life andmental health surveys to healthcare workers before they start the MinnRAP program andthroughout their participation in the program.
Vanda Pharmaceuticals
This is a randomized, double-blind placebo-controlled trial to investigate the efficacyand safety of tradipitant 85 mg orally given twice daily to treat inflammatory lunginjury associated with severe or critical COVID-19 infection.On evaluation for enrollment, participant will need to meet all inclusion and exclusioncriteria. If participant consents, they will be randomized 1:1 to treatment with eithertradipitant 85 mg PO BID or placebo in addition to standard of care for COVID-19infection as per the protocol at the treating hospital. NEWS 2 will be assessed atscreening and daily following randomization. Inflammatory lab markers as detailed shouldbe collected once per day in the morning, preferably at the same time every morning. Allenrolled participants will have whole blood collected for whole genome sequencing.