Study of EDP-235 in Non-hospitalized Adults with Mild or Moderate COVID-19.

Type: Interventional

Start Date: Nov 2022

open study

The study hypothesis is that cromolyn, when combined with standard COVID-19 treatment, will improve patient symptoms and reduce the number of days to improved quality of life. Investigators will study the effects of adding cromolyn to the standard treatment of hospitalized patients with COVID-19 pneumonia and who require supplemental oxygen. Cromolyn will be administered as a nebulized treatment four times a day for four days followed by intranasal administration for two weeks. Investigators may also screen for biomarkers that could indicate inflammatory responses and treatment-induced improvement. Participants will receive either study drug or placebo which will be administered by nebulization for 4 days followed by 14 days of intranasal administration. Participants will be followed while in the hospital and then as outpatients up to day 21 following randomization.

Type: Interventional

Start Date: Nov 2021

open study

The purpose of this study is to investigate the efficient vaccine type as a booster dose for Coronavirus Disease of 2019 (COVID-19) in solid organ transplant recipients.

Type: Interventional

Start Date: Sep 2021

open study

The current study primarily aims to determine the status of vaccination in enrolled cancer patients and identify barriers to coronavirus disease 2019 (COVID-19) vaccination in cancer patients who have not been vaccinated. Secondary objectives include determining the rate of vaccination in those who have ever been COVID-19 positive and those who have never been COVID-19 positive. The study team also seeks to determine factors associated with vaccine-acceptance and vaccine-hesitancy in the adult cancer population, identify side effects of COVID-19 vaccines in vaccinated cancer patients and to examine the effect of COVID-19 vaccination on overall clinical outcome in cancer patients. The study team will be conducting telephone interviews/surveys with up to130 adult cancer patients for data collection.

Type: Observational

Start Date: Aug 2021

open study

The research objective of the UNITE Study is to assess device feasibility of ultrasound application to the spleen using a small wearable ultrasound system to assess its effect on coronavirus disease 2019 (COVID-19) in a pilot study using an early stage prototype device. Specific Aims: 1. Determine the feasibility of splenic ultrasound with a prototype wearable device in affecting physiological markers in COVID-19 infected patients between an ultrasound group versus a control group for the primary analyses; and 2. Evaluate the potential capabilities of splenic ultrasound with this prototype wearable device in affecting additional outcomes in COVID-19 infected patients in the ultrasound group compared to a control group.

Type: Interventional

Start Date: Apr 2021

open study

This research study will evaluate the association of Androgen Receptor (AR) gene expression and COVID-19 disease severity and mortality. The research procedure involves collection of a single saliva sample which will be mailed to the participants by the study team. This saliva will be used in a COVID-19 Androgen Sensitivity Test (CoVAST) which will detect AR gene expression. Eligible participants are males, at least 18 years or older, and have tested positive for COVID-19.

Type: Observational

Start Date: Aug 2020

open study

This is a longitudinal, multi-center, observational study collecting diverse biological measurements and clinical and epidemiological data for the purpose of enabling a greater understanding of the onset of severe outcomes, primarily acute respiratory distress syndrome (ARDS) and/or mortality, in patients presenting to the hospital with suspicion or diagnosis of COVID-19. We seek to understand whether there are early signatures that predict progression to ARDS, mortality, and/or other comorbid conditions. The duration of the study participation is approximately 3 months.

Type: Observational

Start Date: May 2020

open study

The novel coronavirus (COVID-19) is affecting the way many people live their lives, including seeking medical care and maintaining good self-care to keep healthy. Additionally, in the event many people become critically ill at once, COVID-19 has the possibility of overwhelming hospitals to the point where they have to make decisions about how to determine who receives intensive care and life-support measures. Many hospitals as well as local or state governments have been working on policies to determine how to make these decisions. This study seeks to learn about how COVID-19 has affected the way patients and healthcare providers care for themselves and about their thoughts and concerns about policies that may "ration" life-support resources.

Type: Interventional

Start Date: May 2020

open study

PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY) is a prospective cohort study of pregnant and recently pregnant women who are: either patients under investigation for COVID-19 or a confirmed case of COVID-19. Data from PRIORITY will be used to evaluate the impact of COVID-19 on the clinical course and pregnancy outcomes of pregnant women and women within 6 weeks of pregnancy.

Type: Observational [Patient Registry]

Start Date: Mar 2020

open study

The study is designed as a prospective, multicentric, clinical study to investigate the positive percent agreement (PPA) and negative percent agreement (NPA) of the Panbio™ COVID-19/Flu A&B Panel using anterior nasal swab specimens tested directly, relative to the comparator methods, Roche cobas® SARS-CoV-2 (K231306) and Quidel Lyra® Influenza A+B Assay(K230236) (RT-PCR) in symptomatic patients suspected of respiratory viral infection by a healthcare provider.

Type: Interventional

Start Date: Nov 2023

open study

This is a prospective longitudinal cohort study to evaluate the impact of COVID-19 vaccination and booster on maternal and infant immunity against COVID-19 variants over time.

Type: Observational

Start Date: Sep 2022

open study

A retrospective chart review study to determine the effects of psychotropic medications and prior psychiatric diagnoses on COVID-19 patients' disease progression, and severity.

Type: Observational

Start Date: Jan 2022

open study

This is a phase I randomized, placebo-controlled, single site to assess the local and systemic safety of intranasal Q-Griffithsin (Q-GRFT) after 14 doses in approximately 45 adult participants. Participants will be randomized 2:1 (Q-GRFT nasal spray: placebo nasal spray) resulting in 30 participants enrolled into the Q-GRFT arm and 15 participants enrolled into the placebo arm. A clinician will apply two metered doses of Q-GRFT in each nostril (400μl total) of the participant on the day of enrollment. Participants will be monitored in the clinic for 1 hour after administration and return for a 24-hour post dose visit. If safe and acceptable, a second period of daily administration by the participant for 13 days will commence. Safety assessments will be performed at day 7, day 14, and day 28 visits after the initiation of the second period. The expected duration of study participation for each participant will be approximately 6-8 weeks. The primary endpoint is the proportion of participants who experience a related Grade 2 or higher adverse event. Secondary and exploratory endpoints include persistence and systemic absorption of Q-GRFT, acceptability and the impact of Q-GRFT nasal spray on smell.

Type: Interventional

Start Date: Mar 2022

open study

The goal of this longitudinal and observational study is to better understand the psychiatric consequences of COVID-19 over time. Psychiatric outcomes like mood, anxiety, stress, and cognitive symptoms in patients who underwent inpatient hospitalization at NewYork-Presbyterian Hospital/Weill Cornell Medicine for COVID-19 will be assessed at 6 months or later post-discharge.

Type: Observational

Start Date: Dec 2021

open study

The COVID-19 pandemic has caused significant morbidity and mortality across the world. Effective vaccines are now available but underutilized. In July 2021, Ascension Health implemented a mandate requiring all employees to obtain the COVID-19 vaccine by November 12th. In August 2021, the number of COVID-19 cases in the US increased rapidly, specifically in states with lower vaccination rates, many of which are served by Ascension Health facilities. In this study, we will evaluate a rapidly deployed health system initiative to use text messaging to nudge Ascension employees who have not yet been vaccinated to commit to a date and receive vaccination.

Type: Interventional

Start Date: Oct 2021

open study

This observational study will prospectively characterize the long-term symptoms and side effects of COVID-19 in cohorts of people living with and without HIV. This will be achieved through a series of remote study visits involving completing surveys about health history, symptoms, mood, quality of life and changes in health, and up to two blood draws from home through the use of a mobile phlebotomy service.

Type: Observational

Start Date: Jun 2021

open study

This C3 project, Community network-driven COVID-19 testing of vulnerable populations in the Central US, will implement and evaluate a COVID-19 testing and vaccination approach that combines an evidence-based Social Network Testing Strategy (SNS) with community developed COVID-19 public health messages (SNS+). C3 will engage two disenfranchised populations across rural and urban sites in states across the Central US (Texas (TX), Louisiana (LA), Arkansas (AR), Indiana (IN), Illinois (IL)). C3 leverages NIDA's Justice Community Opioid Innovation Network (JCOIN), the PIs' extensive community located COVID-19 testing programs, and a network of established community partnerships. The collaborative community-academic partnerships, research and engagement infrastructure, and team's leadership across JCOIN will ensure that C3 can rapidly recruit, enroll and test most disenfranchised community members, (n=2400) and through this process, accelerate any forthcoming COVID-19 public health prevention interventions. C3 focuses on two communities most impacted by COVID-19: 1) Criminal justice involved (CJI) - non-incarcerated people with previous history of arrest/jail/prison, probation/parole, drug-court attendance, witnessed or experienced a negative interaction with police or law enforcement; and 2) Low-income Latinx - community members at 250% or below Federal Poverty Level. Both of these diverse populations, and the overlap between them, have some of the highest rates of COVID-19 infection and death in the United States. Messaging that affirms individual agency and corrects misinformation, combined with accessible and acceptable testing, is required to accelerate COVID-19 prevention for these populations.Using a two-arm randomized controlled trial design, participants will be enrolled into the Social Network testing Strategy (SNS) arm (involves social networking referrals only) or the Social Network testing Strategy with COVID-19 prevention messages (SNS+) messaging arm. The latter includes affirmation/misinformation correction messaging (discussion tools and coaching). SNS and SNS+messaging arms will both include an initial group of index study participants who will refer their network members into the study and the process will repeat itself one more time for a total of 3 waves. Indexes will refer network members (1st degree) and then those network members will refer one more round (2nd degree).

Type: Interventional

Start Date: Apr 2021

open study

The purpose of this study is to assess whether convalescent plasma therapy is associated with reduced 30-day all-cause mortality in a population of Veteran inpatients with non-severe coronavirus disease 2019 (COVID-19).

Type: Observational

Start Date: May 2020

open study

The objective of the study is to evaluate the efficacy of helmet NIV in reducing the duration of invasive mechanical ventilation in order to minimize ventilator needs during the COVID-19 pandemic.

Type: Interventional

Start Date: Aug 2020

open study

The Hackensack Meridian Health Universal Observational COVID-19, a descriptive observational database, is a multi-center initiative collecting data throughout the Hackensack Meridian Health Network (HMH). HMH utilizes the EPIC system at most of the facilities, which will serve as the primary data source. The database will be designed within the REDCap system. A de-identified dataset will be sent to COTA for primary statistical analysis as requested by the research teams.

Type: Observational [Patient Registry]

Start Date: Mar 2020

open study

This Phase III trial four treatment strategies non-critically ill hospitalized participants (not requiring intensive care unit (ICU) admission and/or mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin.

Type: Interventional

Start Date: Apr 2020

open study

The main objective of our study is to determine if treatment with sirolimus can improve clinical outcomes in hospitalized patients with COVID-19. The investigators will employ a randomized, double blind, placebo-controlled study design. 28 subjects were randomized in a 2:1 fashion to receive sirolimus or placebo. Sirolimus will be given as a 6mg oral loading dose on day 1 followed by 2mg daily for a maximum treatment duration of 14 days or until hospital discharge, whichever happens sooner. Chart reviews will be conducted daily to determine changes in clinical status, concomitant medications and laboratory parameters. Study specific biomarkers will be measured at baseline and then at days 3, 7 and 14.

Type: Interventional

Start Date: Apr 2020

open study

This project is a randomized controlled pilot trial using mixed methods to examine the feasibility, acceptability, and initial effects of a telemedicine group-based intervention designed to improve symptom management and coping in adults with Post-COVID.

Type: Interventional

Start Date: Jan 2023

open study

This is a double-blind, randomized, placebo-controlled single-center clinical trial to explore the safety and efficacy of a full cannabis flower formulation, rich in cannabinoids and terpenes formulation, Xltran Plus™ and Xltran™, both compared to placebo for the treatment of Long COVID patients with prolonged symptoms caused by COVID-19.

Type: Interventional

Start Date: Aug 2024

open study

Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and in infected patients, it produces symptoms which range from completely asymptomatic to those expressing severe illness. Early recognition of those developing severe manifestations allows for rapid and appropriate intervention, including admission to intensive care unit and intensive care therapy, such as mechanical ventilation. A current problem is that only limited data exist predicting the clinical course of COVID-19. This study will determine whether non-invasive urinalysis is useful in assessing and predicting the severity or clinical course of patients with COVID-19.

Type: Observational

Start Date: Sep 2020

open study