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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 70 of 116GeoVax, Inc.
Conditions: Covid-19 Infection
This phase I trial evaluates the side effects and best dose of GEO-CM04S1 (previouslydesignated as COH04S1), a synthetic modified vaccinia Ankara (MVA)-based SARS-CoV-2vaccine, for the prevention of COVID-19 infection. COVID-19 infection is caused by theSARS-CoV-2 virus. SARS-CoV-2 has demonstrated the capability to spread rapidly, leadingto significant impacts on healthcare systems and causing societal disruption. GEO-CM04S1was created by placing small pieces of SARS-CoV-2 DNA (the chemical form of genes) intosynthetic MVA, which may be able to induce immunity (the ability to recognize and fightagainst an infection) to SARS-CoV-2. The purpose of the Phase 1 study is to determine thesafety and the optimal dose of the GEO-CM04S1 vaccine.The Phase 2 study is designed as a multi-center, double-blind, randomized, parallel,study to evaluate the safety profile of 2 dose levels of GEO-CM04S1 as a single boostershot to assess the immune response measured by the fold-increase in antibody againstSARS-CoV-2 Spike protein at day 28 post-injection among healthy adult volunteers.
Medicago
Conditions: SARS-CoV-2 Infection
This Phase 2/3 study is a multi-portion design to confirm that the chosen formulation anddosing regimen of CoVLP has an acceptable immunogenicity and safety profile.The Phase 3 portion is an event-driven, randomized, observer blinded, placebo-controlleddesign that will evaluate the efficacy and safety of the CoVLP formulation compared toplacebo.Subjects will be followed for safety and immunogenicity for a period of 12 months afterthe last vaccination.
Longeveron Inc.
Conditions: ARDS, Human, COVID19
A Phase I, double- blinded, randomized, placebo- controlled study to test the safety ofLomecel-B in Adults suffering from mild to severe acute respiratory distress syndrome(ARDS) due to COVID-19 resultant from 2019-nCoV coronavirus infection, or resultant frominfluenza virus infection.
Rush University Medical Center
Conditions: COVID19, ME/CFS, SARS COV2, Novel Coronavirus Infection, Neurocognitive Disorders, Cardiovascular Diseases
The Innovative Support for Patients with SARS COV-2 Infections Registry (INSPIRE) studyis a CDC-funded COVID-19 project to understand the long-term health outcomes in recentlytested adults, both negative and positive, who have suspected COVID symptoms at the timeof their test. Participants will complete short online surveys every 3 months for 18months, share information about their health using a secure web-based platform, and arecompensated for their time.
Biostrap
Conditions: COVID19, Cardiovascular Complication, Behavioral Changes
This is an observational COVID-19 study that uses wearable health monitoring technologyto follow COVID-19 positive individuals to monitor persistent symptoms and any potentiallong-term complications or cardiovascular and behavioral impacts from the disease.
McMaster University
Conditions: COVID19, Corona Virus Infection, Mobility Limitation, Frailty
Older adults and those with chronic underlying health conditions are the most susceptibleto COVID-19 and its complications. Although there has been a rapid response to studyingthe effects of COVID-19 in the acute stages, little is known about recovery over thelonger-term. Older adults who survive the diseases are at risk of developing persistentmobility limitations due to extensive bed rest during hospitalization. For older patientsand those with underlying frailty recovering from COVID-19, this could rapidly lead tosignificant physical deconditioning and rapid declines in mobility. Understanding thetrajectory of functional recovery of older hospitalised patients with COVID-19 in theshort- and long-term is critical to improving patient outcomes and informing health andrehabilitative interventions for survivors.
LumiraDx UK Limited
Conditions: COVID19
Evaluation of the agreement between fingerstick samples, venous blood, serum and plasmasamples when using the LumiraDx SARS-CoV-2 Ab Test against the reference method, usingstandard qualitative comparison techniques.
National Institutes of Health Clinical Center (CC)
Conditions: COVID-19
Background:People who are recovering from COVID-19 may continue to have problems that affect theirdaily life. For instance, they might feel overly tired. Researchers want to learn ifexercise can help people recover after COVID-19 infection.Objective:To study if participation in a rehabilitation exercise program can help people recoveringfrom COVID-19.Eligibility:Adults ages 18-80 with a lab-confirmed SARS-CoV2 infection (the virus that causesCOVID-19), and are still having some symptoms.Design:Participants will have a medical history and physical exam. They will give blood andurine samples. They will have tests to measure heart and lung function. Their bloodvessels will be assessed.Participants will have a computed tomography scan of the body. They will have anultrasound of the muscles in their arms, legs, and chest.Participants will take a 6-minute walk test. They will take other balance and movementtests.Participants will walk on a treadmill while hooked up to a monitor. Then they will beinterviewed. It will be audio-recorded.Participants will complete surveys about their symptoms and daily activities.Participants will take a smell test. For this, they will identify different smells. Theywill also have memory, attention, and mental functioning tests.Participants will wear an activity monitor on their wrist 24 hours a day. They willexercise 3 times a week for 10 weeks by moving vigorously on a track or treadmill for 30minutes. They will attend education classes once a week for 10 weeks.Participants will be contacted by phone or email every 3 months for 1 year after theycomplete the exercise part of the study. They will wear an activity monitor for up to 2weeks.
University Health Network, Toronto
Conditions: Stress
The aims of this study are to assess whether the use of a MBI therapy delivered remotelyis associated with a reduction of perceived stress among HCPs in the Radiation MedicineProgram (RMP) and with a decrease risk of burnout during and post COVID-19.
Regeneron Pharmaceuticals
Conditions: Chronic Obstructive Pulmonary Disease
Primary Objective:Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPDSecondary Objectives:Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD - Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD - Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD - Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPDSecondary population (current smokers cohort) - Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD - Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD - Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD - Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD - Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD