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Displaying 1 - 20 of 27

Open Actively Recruiting

Use of Multi-modal (MMHealth) Remote Audio and Video Sensing for Estimation of Physiological Vital Signs in Hospitalized and Non-Hospitalized Patients

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Age Group: All
Contact: LALEH JALILIAN
Open Actively Recruiting

COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders

This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different COVID-19 vaccine booster doses in participants with autoimmune disease requiring immunosuppressive medications. All study participants will have negative serologic or sub-optimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S (RBD) result ≤ 50 U/mL) to initial COVID-19 vaccine regimen with Moderna COVID-19 vaccine, Pfizer-BioNTech COVID-19 vaccine, or Janssen COVID-19 vaccine.

The study will initially focus on 5 autoimmune diseases: - Systemic Lupus Erythematosus (SLE) - Rheumatoid Arthritis (RA) - Multiple Sclerosis (MS) - Systemic Sclerosis (SSc), and - Pemphigus.

Phase: Phase 2
Primary Purpose: Prevention
Gender: All
Contact: Mia Vasquez-Gutierrez
Open Actively Recruiting

ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19

This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints in hospitalized adults diagnosed with Coronavirus Disease 2019 (COVID-19). Big Effect Trial (BET) is a proof-of-concept study with the intent of identifying promising treatments to enter a more definitive study. The study will be conducted in up to 70 domestic sites and 5 international sites. The study will compare different investigational therapeutic agents to a common control arm and determine which have relatively large effects. In order to maintain the double blind, each intervention will have a matched placebo. However, the control arm will be shared between interventions and may include participants receiving the matched placebo for a different intervention.

The goal is not to determine clear statistical significance for an intervention, but rather to determine which products have clinical data suggestive of efficacy and should be moved quickly into larger studies. Estimates produced from BET will provide an improved basis for designing the larger trial, in terms of sample size and endpoint selection. Products with little indication of efficacy will be dropped on the basis of interim evaluations. In addition, some interventions may be discontinued on the basis of interim futility or efficacy analyses. One or more interventions may be started at any time. The number of interventions enrolling are programmatic decisions and will be based on the number of sites and the pace of enrollment. At the time of enrollment, subjects will be randomized to receive any one of the active arms they are eligible for or placebo. Approximately 200 (100 treatment and 100 shared placebo) subjects will be assigned to each arm entering the platform and a given site will generally have no more than 3 interventions at once. The BET-B stage will evaluate the combination of remdesivir with lenzilumab vs remdesivir with a lenzilumab placebo. The primary objective is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8.

Phase: Phase 2
Primary Purpose: Treatment
Gender: All
Contact: Melissa Arevalo
Investigator: Otto O. Yang, MD
Open Actively Recruiting

Functional, imaging, and respiratory evaluation in CORAL: FIRE CORAL

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Contact: Julia Vargas
Investigator: Nida Qadir, MD
Open Actively Recruiting

Adult Inpatient SARS-CoV-2 Vaccine Effectiveness Surveillance

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Age Group: Adults
Contact: Nida Qadir
Investigator: Nida Qadir, MD
Open Actively Recruiting

COVID19 SARS Vaccinations: Systemic Allergic Reactions to SARS-CoV-2 Vaccinations

Background: Allergic reactions have been reported to occur after vaccination with both the Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine. Allergic reactions range from mild to severe and include life- threatening anaphylactic reactions, although no deaths have been reported with either vaccine.

This study is designed with two principal aims: - To estimate the proportions of systemic allergic reactions to the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine in a High-Allergy/Mast Cell Disorder (HA/MCD) population, and - If the risk in the HA/MCD is demonstrable, to determine whether the proportions are higher in the HA/MCD in comparison to a representative population without severe allergies or mast cell disorders

Phase: Phase II
Primary Purpose: Treatment
Gender: All
Age Group: All
Contact: Alexis Stephens
Open Actively Recruiting

Accelerating COVID-19 Therapeutic Interventions and Vaccines 4 ACUTE

This is a randomized, open label, adaptive platform trial to compare the effectiveness of antithrombotic and additional strategies for prevention of adverse outcomes in COVID-19 positive inpatients

Phase: Phase IV
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Julia Vargas
Investigator: George W. Lim, MD
Open Actively Recruiting

PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US

The purpose of this study is to describe the pharmacokinetic (PK) properties and safety of remdesivir (GS-5734TM) (RDV) administered to pregnant and non-pregnant women with COVID-19. It is a Phase I, prospective, open label, non-randomized opportunistic PK study in pregnant and non-pregnant women of childbearing potential hospitalized and receiving RDV for treatment of COVID-19. RDV will not be provided as part of the study.

Gender: Female
Contact: Michele Carter
Open Actively Recruiting

Chinese Herbal Formula for COVID-19

This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate a 21-herb formula named modified Qing Fei Pai Du Tang (mQFPD) to treat COVID-19-positive outpatients with mild-to-moderate symptoms assigned to self-quarantined and home management. This the study aims to establish the safety and feasibility of the use of mQFPD vs placebo in 66 total subjects. Subsequent trials will evaluate other therapeutics as well as the efficacy of mQFPD in a larger study population.

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Contact: Andrew Shubov
Investigator: Andrew Shubov, MD
Open Actively Recruiting

Surveillance of Respiratory Viruses in the Critically Ill: 2020-2021 IVY Network Surveillance Study

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Age Group: Adults
Contact: Adreanne Rivera
Investigator: Nida Qadir, MD
Open Actively Recruiting

ACTIV-3: Therapeutics for Inpatients With COVID-19

This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Contact: Julia Vargas
Investigator: George W. Lim, MD
Open Actively Recruiting

Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE)

The Innovative Support for Patients with SARS COV-2 Infections Registry (INSPIRE) study is a CDC-funded COVID-19 project to understand the long-term health outcomes in recently tested adults, both negative and positive, who have suspected COVID symptoms at the time of their test. Participants will complete short online surveys every 3 months for 18 months, share information about their health using a secure web-based platform, and are compensated for their time.

Gender: All
Age Group: Adults
Contact: COVID19 INSPIRE Registry
Open Actively Recruiting

The Safety of Molnupiravir (EIDD-2801) and Its Effect on Viral Shedding of SARS-CoV-2 (END-COVID)

Designed as a multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of EIDD-2801 on SARS-CoV-2 Virus Shedding in Newly Hospitalized Adults with polymerase chain reaction (PCR)-Confirmed COVID-19.

Phase: Phase II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Yesenia Calzada
Open Actively Recruiting

NCI COVID-19 in Cancer Patients, NCCAPS Study

This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

Phase: N/A
Gender: All
Age Group: Adults
Contact: Jenny Lester
Open Actively Recruiting

Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation

Interventional, randomized, double-blind, placebo-controlled study encompassing 2 development phases (Phase 2 and Phase 3).

Phase: Phase II/III
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Karla Largaespada
Investigator: Tisha S. Wang, MD
Open Actively Recruiting

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Remdesivir (GS-5734™) in Participants From Birth to < 18 Years of Age With Coronavirus Disease 2019 (COVID-19)

The primary objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics (PK) of remdesivir (RDV) in participants with laboratory-confirmed coronavirus disease 2019 (COVID-19) aged 0 days to < 18 years.

Phase: Phase II/III
Primary Purpose: Treatment
Gender: All
Age Group: Children
Contact: Elizabeth Lang
Open Actively Recruiting

COVID-19 Questionnaire in UCLA Rheumatoid Arthritis Patients

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Age Group: Adults
Contact: Nicolette Morris
Open Actively Recruiting

COVID-19 Surveillance in Healthcare Workers and Patients: Observational Studies from the Influenza Vaccine Effectiveness in the Critically Ill (IVY) Network

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Age Group: Adults
Contact: Nida Qadir
Investigator: Nida Qadir, MD
Open Actively Recruiting

Acupressure for COVID-19 Related Quality of Life and Stress

This study is being conducted to evaluate the efficacy of acupressure in promoting health and well-being among healthcare workers during the COVID-19 pandemic. The investigators hypothesize that providing participants with a remote and standardized self-acupressure training program will improve HRQOL and the perception of stress. In the event that the study demonstrates acupressure to be safe and effective for this indication, the training could be scaled up and deployed at low-cost nationally and internationally.

Phase: N/A
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Ryan Abbott
Investigator: KaKit P. Hui, MD
Open Actively Recruiting

COVID Evaluation of Risk for Emergency Departments (COVERED) Project

This CDC sponsored surveillance project is designed to assess risk exposures and COVID-19 infections among working emergency department personnel. The project will require participants to provide ongoing information on risk exposures, and will collect additional information on institutional and community risks. These risk assessments will be combined with assessment of disease status, as determined by serologic testing at two-week intervals. The goal of the project is to identify the most important and potentially correctable risk factors that emergency department personnel face while dealing in with the coronavirus pandemic.

Age Group: Adults
Contact: Julia Vargas