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 20 of 25Fondazione 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.
West China Hospital
This is a phase Ⅰ/Ⅱ, single-center, randomized, double-blind, placebo-controlled study,to evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19vaccine (Sf9 cells) in the subjects from healthy aged 6-17 years with immunizationprocedures 0, 21, 42 days and doses (10μg/20μg/40μg).
Celltex Therapeutics Corporation
This is an interventional new drug clinical trial for a Phase 2 randomized, double-blind,and placebo control study using intravenous injection of allogeneic adipose stem cells(Celltex AdMSCs) for subjects with severe COVID-19.
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)
Sinocelltech Ltd.
The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlledPhase II/III clinical trial. It will be conducted at selected investigational sitesglobally. The study is comprised of 2 parts.
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.
University of California, Davis
This is a PET/CT study using the 18F-αvβ6-binding-peptide.The goal of this study is toevaluate this peptide in patients after infection with SARS CoV2.
Medpace, Inc.
This is a randomized, double-blinded, placebo-controlled study of AVM0703 administered asa single intravenous (IV) infusion to patients with moderate or severe immediatelylife-threatening Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 or influenza(A or B). The study is designed to evaluate the safety, tolerability, andpharmacokinetics of single dose of AVM0703 in these ARDS patients.