1,497 matching studies

Sponsor Condition of Interest
Immune Response to SARS-CoV-2/COVID-19 Vaccination in Sarcoidosis
Northwestern University Sarcoidosis SARS-CoV2 Infection Vaccine Response Impaired
People with sarcoidosis, particularly those with significant lung and/or cardiac involvement, who become infected with severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) are likely at increased risk of complications or death from COVID-19. While SARS-CoV-2 vaccines... expand

People with sarcoidosis, particularly those with significant lung and/or cardiac involvement, who become infected with severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) are likely at increased risk of complications or death from COVID-19. While SARS-CoV-2 vaccines are highly efficacious in preventing COVID-19 in the general population, whether vaccination provides similar protection in people with sarcoidosis is unknown. The investigators hypothesize that people with sarcoidosis develop less robust antibody and cell-mediated immune responses to SARS-CoV-2 vaccination than healthy individuals, both as a consequence of the disease itself and due to treatment with immunosuppressive medications. This hypothesis will be examined by determining levels of anti-SARS-CoV-2 spike protein immunoglobulin G (IgG) antibody (Specific Aim 1) and measuring SARS-CoV-2-specific activation of peripheral blood T cells (Specific Aim 2) following SARS-CoV-2 vaccination in individuals with sarcoidosis treated and not treated with immunosuppressive medications, in comparison to age- and sex-matched healthy controls. For Specific Aim 1, a second-generation anti-SARS-CoV-2 spike IgG assay calibrated against an independent virus neutralization assay will be utilized. The results of this investigation will address a critical gap in the understanding of vaccine responses in people with sarcoidosis. In addition, the study will contribute knowledge needed to inform clinicians' recommendations to sarcoidosis patients regarding risk of infection after SARS-CoV-2 vaccination, and will help lay the basis for future trials to evaluate the possible benefit of vaccine boosters in individuals with poor immune responses to initial vaccination.

Type: Observational [Patient Registry]

Start Date: Dec 2021

open study

VERU-111 in the Treatment of SARS-Cov-2 Infection by Assessing Its Effect on the Proportion of Patients...
Veru Inc. SARS-CoV Infection
To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of patients who die on study (prior to Day 60). expand

To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of patients who die on study (prior to Day 60).

Type: Interventional

Start Date: May 2021

open study

Feasibility Study of Hematology Parameters in COVID-19 Disease
Beckman Coulter, Inc. Covid19 Sepsis Adults Emergency Department
The purpose of this study is to evaluate the potential for MDW and other CPD parameters (measured with CBC-DIFF) to identify COVID-19 diseased adult individuals presenting to the hospital with symptoms suggestive of COVID-19 or respiratory infection and whose standard of care... expand

The purpose of this study is to evaluate the potential for MDW and other CPD parameters (measured with CBC-DIFF) to identify COVID-19 diseased adult individuals presenting to the hospital with symptoms suggestive of COVID-19 or respiratory infection and whose standard of care includes CBC-DIFF and microbial testing.

Type: Observational

Start Date: Dec 2020

open study

A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between...
ModernaTX, Inc. SARS-CoV-2
The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children in 2 doses, 28 days apart. expand

The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children in 2 doses, 28 days apart.

Type: Interventional

Start Date: Mar 2021

open study

Transfer of Infection Fighting Immune Cells Generated in the Laboratory to High Risk Patients With COVID-19...
Thomas Jefferson University Covid19
This clinical trial will study the safety and efficacy of COVID-19-specific T cells when given as treatment to adult patients (age ≥ 18 years) with a COVID-19 infection. This immunologic treatment is aimed at patients, who are at high risk of progression due to their advanced... expand

This clinical trial will study the safety and efficacy of COVID-19-specific T cells when given as treatment to adult patients (age ≥ 18 years) with a COVID-19 infection. This immunologic treatment is aimed at patients, who are at high risk of progression due to their advanced age, or other underlying health conditions. The outcomes of patients receiving the T cells (Arm A) will be compared to patients treated with standard of care (Arm B).

Type: Interventional

Start Date: Sep 2021

open study

Sargramostim Use in COVID-19 to Recover Patient Health
Partner Therapeutics, Inc. Covid19 SARS-CoV Infection
The purpose of this research is to understand if the study drug, also called sargramostim or Leukine®, can help prevent the worsening of COVID-19 when the study drug is inhaled. This study will also help researchers understand if inhaled sargramostim can help prevent visits... expand

The purpose of this research is to understand if the study drug, also called sargramostim or Leukine®, can help prevent the worsening of COVID-19 when the study drug is inhaled. This study will also help researchers understand if inhaled sargramostim can help prevent visits to the emergency room or hospitalization, or death.

Type: Interventional

Start Date: Apr 2021

open study

Cannabidiol in Patients With COVID-19 and Cardiovascular Disease or Risk Factors
Cardiol Therapeutics Inc. COVID-19 Cardiovascular Diseases Cardiovascular Risk Factor
Non-critical patients, hospitalized within the previous 24 hours who tested positive for COVID-19 and have a prior history of cardiovascular disease (CVD) and/or significant risk factors for CVD will be treated for 28 days. expand

Non-critical patients, hospitalized within the previous 24 hours who tested positive for COVID-19 and have a prior history of cardiovascular disease (CVD) and/or significant risk factors for CVD will be treated for 28 days.

Type: Interventional

Start Date: Apr 2021

open study

COVID-19 Watch + COVID-19 Pulse
University of Pennsylvania Covid19
The clinical guidance for 90 percent of infected COVID-19 adult patients who do not meet eligibility for inpatient admission is to self-isolate. To support these patients, alternatives to in-person care are needed to manage an unpredictable clinical course; identify and intercept... expand

The clinical guidance for 90 percent of infected COVID-19 adult patients who do not meet eligibility for inpatient admission is to self-isolate. To support these patients, alternatives to in-person care are needed to manage an unpredictable clinical course; identify and intercept patients rapidly deteriorating at home, prevent viral spread during in-person visits; and minimize future surges in emergency departments (EDs). In addition, fingertip pulse oximeters have been proposed to improve in-home early detection of respiratory deteriorations but are untested and the operational infrastructure to support large-scale monitoring is limited. While telemedicine has been widely adopted during the pandemic as an alternative to conventional outpatient care, limited telemedicine access may be exacerbating observed disparities for Black and Latino patients. In our health system, Black and Latino patients used video-visits 15 percent less often than white patients. Text messaging and phone calls may improve healthcare access for communities of color, but the evidence for these telecommunication modalities to be effective and improve equity are limited. The University of Pennsylvania Health System (UPHS) developed and deployed COVID Watch to improve access to health care for COVID-19 patients who are self-isolating at home. COVID Watch sends twice-daily, scheduled text messages to assess patients for shortness of breath using a clinical algorithm to determine whether patients need an urgent escalation to a team of dedicated, on-call nurses within one hour. These nurses are supported by an on-call team of clinicians who can conduct urgent phone or video assessments. Patients can also trigger the algorithmic assessment independent of the scheduled messages. As of May 21, 2020, COVID Watch has managed 3,628 COVID-19 patients at home, of which 1,295 are confirmed COVID-19 positive; of these, 61 percent are Black or Latino, higher than the proportion of all UPHS COVID-19 positive patients that are Black or Latino (55 percent).

Type: Interventional

Start Date: Nov 2020

open study

An Expanded Access Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab...
Genentech, Inc. HER2-positive Breast Cancer
This single arm, multicenter study provides the pertuzumab and trastuzumab fixed-dose combination formulation for subcutaneous injection (PH FDC SC) administered at home by a home health nursing provider for patients with human epidermal growth factor receptor 2-positive (HER2+)... expand

This single arm, multicenter study provides the pertuzumab and trastuzumab fixed-dose combination formulation for subcutaneous injection (PH FDC SC) administered at home by a home health nursing provider for patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer who have completed concurrent chemotherapy with pertuzumab (Perjeta) and trastuzumab (Herceptin) by intravenous administration (P+H IV) and are currently receiving or will be receiving maintenance therapy with P+H IV, PH FDC SC, or trastuzumab SC in the clinic. The main objective is to enable continuity of care during the COVID-19 pandemic. This study will enroll approximately 200 patients in the United States. Participants will receive treatment every 3 weeks and continue treatment unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity or participant withdrawal. Only participants with HER2+ early breast cancer will receive PH FDC SC to complete 18 cycles of dual blockade, including the P+H IV, PH FDC SC, or trastuzumab SC they received prior to enrolling in this study. A remote cardiac surveillance substudy will be optional for patients enrolled at the Mayo Clinic (select sites) and Memorial Sloan Kettering Cancer Center (MSKCC) sites. The Sponsor may decide to terminate the study when the COVID-19 pandemic is no longer a risk for this patient population.

Type: Expanded Access

open study

Predicting Outcomes for Covid-19 Using Sonography
Stanford University COVID-19 Pneumonia, Viral
This study seeks to investigate the role of lung ultrasound in caring for Covid-19 positive patients and whether it can be used to predict patient deterioration. This information will be vital for healthcare workers who seek to identify Covid-19 pneumonia or patients at risk... expand

This study seeks to investigate the role of lung ultrasound in caring for Covid-19 positive patients and whether it can be used to predict patient deterioration. This information will be vital for healthcare workers who seek to identify Covid-19 pneumonia or patients at risk for deterioration early in the disease course.

Type: Observational

Start Date: Mar 2020

open study

A Randomized Placebo-controlled Safety and Dose-finding Study for the Use of the IL-6 Inhibitor Clazakizumab...
NYU Langone Health COVID-19
In this study invetigators propose to administer clazakizumab to patients with life-threatening COVID-19 infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a double-blinded randomized multi-center trial designed... expand

In this study invetigators propose to administer clazakizumab to patients with life-threatening COVID-19 infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a double-blinded randomized multi-center trial designed as a phase II dose-finding three arm trial with seamless adaptive transition to a phase III efficacy trial. For phase II, patients were randomized 1:1:1 ratio to three study arms and received clazakizumab at a dose of 12.5 mg, 25 mg or placebo. Based on interim analysis, the low dose arm was dropped and the phase III portion of the study continued to enroll patients randomized 1:1 to high dose clazakizumab or placebo. Based on interim analysis, the remaining 10 subjects at NYU will be randomly assigned to a 1:1 ratio to two arms that will receive clazakizumab at a dose of 25 mg or placebo. The NYU site will serve as the central data management site for other centers who undertake this protocol. Other sites will enroll patients based on the two arm 1:1 randomization. 60 patients at outside sites are expected to enroll.

Type: Interventional

Start Date: Mar 2020

open study

Ocular Findings and Viral Persistence in Ocular Fluids in COVID-19 Survivors
National Eye Institute (NEI) COVID-19
Background: Some people who have had COVID-19 experience changes in the eye. Sometimes these changes are subtle and may not affect vision. Researchers want to learn how many people experience these eye changes and where in the eye they occur to better understand the outcomes... expand

Background: Some people who have had COVID-19 experience changes in the eye. Sometimes these changes are subtle and may not affect vision. Researchers want to learn how many people experience these eye changes and where in the eye they occur to better understand the outcomes of COVID-19 and its treatments. Objective: To examine possible changes in the eye that might have occurred as a result of COVID-19. Eligibility: Adults age 18 and older who were diagnosed with COVID-19 and recovered. Design: Participants will be screened with a medical history and physical exam. They will have blood tests. Participants will have an eye exam. Their pupils will be dilated with eye drops. Eye pressure and movements will be measured. Participants will have optical coherence tomography. Pictures will be taken of the retina and the inside of the eyes. Participants may have fluorescein angiography and indocyanine green angiography. They will be given a dye through an intravenous line. The dye will travel up to the blood vessels in their eyes. Pictures will be taken of the dye as it flows through the blood vessels. Participants may have electroretinography to test the retina. They will sit in the dark with their eyes patched for 30 minutes. Then they will watch flashing lights while wearing contact lenses that sense signals from the retina. Participants may have adaptive optics-assisted imaging. They will look at a specific location while images are taken of the retina. During the study, participants will have blood drawn through a needle in their arm. Fluid or tissue from the eye may be obtained if participants have a medically needed procedure. Participation will last for 12 months.

Type: Observational

Start Date: Feb 2021

open study

GlowTest COVID-19 Antigen Home Test Kit QRI Use Study
Arion Bio Covid 19
The objective of the study is to determine the usability of the GlowTest COVID-19 Antigen Home Test in a simulated home use environment. This is an open label study to evaluate the usability of the GlowTest COVID-19 Antigen Home Test using information from the Quick Reference... expand

The objective of the study is to determine the usability of the GlowTest COVID-19 Antigen Home Test in a simulated home use environment. This is an open label study to evaluate the usability of the GlowTest COVID-19 Antigen Home Test using information from the Quick Reference Instructions and website.

Type: Interventional

Start Date: Dec 2021

open study

COVID-19 Vaccine Response in Sickle Cell Disease
ASH Research Collaborative Sickle Cell Disease COVID-19
The purpose of this study is to assess the antibody response to COVID-19 vaccination in a cohort of patients with sickle cell disease (SCD) and to assess vaccine and SCD related complications around the time of vaccination. expand

The purpose of this study is to assess the antibody response to COVID-19 vaccination in a cohort of patients with sickle cell disease (SCD) and to assess vaccine and SCD related complications around the time of vaccination.

Type: Observational

Start Date: Dec 2021

open study

Yogic Breathing and Guided Meditation for Long Covid Symptoms
Beth Israel Deaconess Medical Center COVID-19 Stress Shortness of Breath
This study aims to assess the impact of brief digitally delivered breathing practice and guided meditation on post-Covid physical and mental symptoms in Long Covid Patients. expand

This study aims to assess the impact of brief digitally delivered breathing practice and guided meditation on post-Covid physical and mental symptoms in Long Covid Patients.

Type: Interventional

Start Date: Sep 2021

open study

A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters
ModernaTX, Inc. SARS-CoV-2
The main goal of this study is to assess the safety, reactogenicity, and immunogenicity of the study vaccines. expand

The main goal of this study is to assess the safety, reactogenicity, and immunogenicity of the study vaccines.

Type: Interventional

Start Date: Dec 2021

open study

Randomized Double-Blind Phase 2 Study of Allogeneic HB-adMSCs for the Treatment of Chronic Post-COVID-19...
Hope Biosciences Stem Cell Research Foundation Post COVID-19 Syndrome
This study will enroll up to 80 subjects with Chronic Post COVID-19 Syndrome. Subjects will receive four intravenous injections of either allogeneic HB-adMSC's or a placebo over 10 weeks with two follow-up visits and an end of study visit at week 26. expand

This study will enroll up to 80 subjects with Chronic Post COVID-19 Syndrome. Subjects will receive four intravenous injections of either allogeneic HB-adMSC's or a placebo over 10 weeks with two follow-up visits and an end of study visit at week 26.

Type: Interventional

Start Date: Dec 2021

open study

Validation of HyperDetector for SARS-CoV-2
HyperSpectral APD SARS-COV2 Infection
To evaluate the HyperDetector as a method to rapidly screen SARS-CoV-2 To determine the sensitivity and specificity of the screening assay performed on oral swab and saliva specimens, compared to a validated RT-PCR COVID-19 method using nasal or nasopharyngeal swabs and... expand

To evaluate the HyperDetector as a method to rapidly screen SARS-CoV-2 To determine the sensitivity and specificity of the screening assay performed on oral swab and saliva specimens, compared to a validated RT-PCR COVID-19 method using nasal or nasopharyngeal swabs and to separately collected nasal swabs, oral swabs, oral rinse and saliva samples. To determine the best workflow for using such an assay to reflex suspicious/positive samples to a validated RT-PCR COVID-19 assay.

Type: Observational

Start Date: Dec 2020

open study

Patients' Attitudes Toward and Experiences With Buprenorphine Treatment
Cambridge Health Alliance Opioid-use Disorder Acceptability of Health Care Opioid-Related Disorders
This study will disseminate five surveys collecting individual's attitudes and experiences during buprenorphine treatment for Opioid Use Disorder during the COVID-19 pandemic. expand

This study will disseminate five surveys collecting individual's attitudes and experiences during buprenorphine treatment for Opioid Use Disorder during the COVID-19 pandemic.

Type: Observational

Start Date: Nov 2021

open study

Healthcare Provider Human Papillomavirus Education and Professional Skills Intervention
University of Texas, El Paso Health Personnel Attitude Health Knowledge, Attitudes, Practice
Healthcare providers (HCP) serving the El Paso U.S.-Mexico Border Region will be recruited to compare educational and professional skills interventions focused on the human papillomavirus (HPV). Our hypothesis is that improving provider knowledge and communication strategies about... expand

Healthcare providers (HCP) serving the El Paso U.S.-Mexico Border Region will be recruited to compare educational and professional skills interventions focused on the human papillomavirus (HPV). Our hypothesis is that improving provider knowledge and communication strategies about HPV and its vaccine will reduce hesitancy and increase uptake and completion among the populations they serve.

Type: Interventional

Start Date: Dec 2021

open study

A Clinical Evaluation of Pine Trees Health Test System Including the Pine Trees Health Reader and COVID-19...
Pine Trees, Inc. SARS (Severe Acute Respiratory Syndrome) Covid19
The scope of this study is to validate the Pine Trees Health COVID-19 Molecular Test with unique clinical specimens from across two (2) geographically diverse point-of-care testing sites in the United States. The results will be analyzed and compared against results from the... expand

The scope of this study is to validate the Pine Trees Health COVID-19 Molecular Test with unique clinical specimens from across two (2) geographically diverse point-of-care testing sites in the United States. The results will be analyzed and compared against results from the CDC 2019- Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. The primary objective is to generate clinical performance data for the Pine Trees Health COVID19 molecular diagnostic test in the point-of-care setting.

Type: Observational

Start Date: Aug 2021

open study

Performance of a Remote Monitoring Program for Patients Diagnosed With COVID-19
George Washington University Covid19 Infectious Disease SARS-CoV Infection
The GW Medical Faculty Associates recently launched a remote monitoring program for patients diagnosed with COVID-19. Patients are provided with a home pulse oximeter and thermometer. Participants complete daily surveys about their symptoms and vital signs and are escalated to... expand

The GW Medical Faculty Associates recently launched a remote monitoring program for patients diagnosed with COVID-19. Patients are provided with a home pulse oximeter and thermometer. Participants complete daily surveys about their symptoms and vital signs and are escalated to receive phone calls and video visits if responses are abnormal. Investigators would like to complete a study of the program to understand: 1. Operational parameters of program performance, such as how many patients were enrolled and how many patients completed monitoring 2. Clinical course of patients, including their reported symptoms over time and clinical endpoints such as hospitalization or ICU admission 3. Patient satisfaction with program

Type: Observational

Start Date: Sep 2020

open study

Study to Reinforce Immunity (STRI) Phase 2 Clinical Trial
Eyecheck, Inc. Covid19
Protocol STRI12 - Study to Reinforce Immunity (STRI) - A Phase 2 Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety and Efficacy of STRI Formula in Non-Hospitalized Participants with COVID-19 (the Study) expand

Protocol STRI12 - Study to Reinforce Immunity (STRI) - A Phase 2 Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety and Efficacy of STRI Formula in Non-Hospitalized Participants with COVID-19 (the Study)

Type: Interventional

Start Date: Nov 2021

open study

A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects
Suzhou Kintor Pharmaceutical Inc, Covid19
This study is an adaptive Phase III randomized double-blind placebo-controlled trial to evaluate the efficacy and safety of Proxalutamide (GT0918) in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted at approximately 80 sites... expand

This study is an adaptive Phase III randomized double-blind placebo-controlled trial to evaluate the efficacy and safety of Proxalutamide (GT0918) in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted at approximately 80 sites globally. The study will compare GT0918 plus standard of care (SOC) with the placebo plus SOC. Approximately 1030 subjects will be randomized in a 1:1 ratio to either GT0918 plus SOC or placebo plus SOC group.

Type: Interventional

Start Date: Sep 2021

open study

Pilot Study for PET/MR Imaging of Covid-19
Stanford University Brain Diseases Covid19
The primary goal of this project is to study the feasibility of a prototype brain-dedicated PET insert for an MR scanner for simultaneous acquisition of PET/MR images of metabolism and perfusion in Covid-19 negative and positive/once positive subjects. This study serves as a... expand

The primary goal of this project is to study the feasibility of a prototype brain-dedicated PET insert for an MR scanner for simultaneous acquisition of PET/MR images of metabolism and perfusion in Covid-19 negative and positive/once positive subjects. This study serves as a pilot study for establishing an imaging protocol for combined PET and MR derived functional information as well as MRI acquired anatomical information.

Type: Interventional

Start Date: Jan 2022

open study