This is a phase 2 double-blind, randomized study of PBI-0451(Pomotrelvir) in nonhospitalized symptomatic adults with COVID-19. PBI-0451(Pomotrelvir) is a new chemical entity and inhibitor of the main protease of coronaviruses, including the SARS-CoV-2 that causes COVID-19 disease. This study is designed to evaluate the antiviral activity, safety, and efficacy of orally administered PBI-0451(Pomotrelvir) compared with placebo.

Type: Interventional

Start Date: Sep 2022

open study

This is an open-label study examining the safety and tolerability of sotrovimab, administered in two sequential doses as prophylaxis in immunocompromised patients with impaired humoral immunity against SARS-CoV-2.

Type: Interventional

Start Date: Feb 2022

open study

Background: Coronavirus disease (COVID-19) is a viral infection. It has spread rapidly across the globe. It has overwhelmed health systems. Researchers are concerned that it may undo years of progress in the reduction of cancer-specific death. They want to test a vaccine that might protect people with cancer from COVID-19. Objective: To test the safety and efficacy of a vaccine using messenger ribonucleic acid (mRNA)-1273 that may protect people with cancer from COVID-19. Eligibility: Adults ages 18 and older who have a solid tumor or blood cancer and who may benefit from a vaccine that might prepare their immune system for fighting and preventing infection from COVID-19. Patients with solid tumors must be receiving treatment with an immunotherapy agent. Design: Participants will be screened with a medical history, medicine review, and physical exam. They will have blood tests. They will have a pregnancy test if needed. Participants will get 2 doses of the mRNA-1273 vaccine if they have not been vaccinated already. It will be injected into a muscle in the arm on Days 1 and 29. They will be followed for 12 months after the second dose. Participants will have study visits at the Clinical Center on Days 1, 29, 36,57, 209, and 394. Some visits will last about 4-6 hours. Patients will be able to get up to 3 doses of mRNA-1273 as a booster on trial if they have already completed a primary series of a vaccine. Participants who have already received a booster dose of vaccine will be able to enroll to receive additional boosters. It will be injected into a muscle in the arm on Day 1. Participants will be followed for 12 months after their last booster injection. Participants who receive booster doses will have study visits at the Clinical Center on Days 1, 29, 57, 180 and 360. Participants will give blood and saliva samples for research. Participation will last about 16 months.

Type: Interventional

Start Date: Apr 2021

open study

The COVID-19 CHAMPS Study will obtain data on the physical and mental health and well-being of workers potentially exposed to the SARS-CoV-2 virus in the course of their duties. Included are a broad range of occupations including those working in the community (police officers, firefighters, emergency personnel, screening staff) as well as in permanent or temporary sites that care for patients (service staff, nurses, physicians and other health professionals). CHAMPS will obtain data on various exposure factors and health and create a registry of participants for extended follow up and sub-studies.

Type: Observational [Patient Registry]

Start Date: May 2020

open study

This randomized blinded multi-center phase 2 trial will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma among adults with severe COVID-19. Adults ≥18 years of age may participate. A total of 219 eligible subjects will be randomized in a 2:1 ratio to receive either high-titer anti-SARS-CoV-2 plasma or non-convalescent fresh frozen plasma (control plasma).

Type: Interventional

Start Date: Apr 2020

open study

The goal of this clinical trial is to develop a comprehensive mental health counseling program purposed to address the social determinant of health impacts of the coronavirus disease of 2019 (COVID-19). The main questions the investigators aim to answer are: 1) What are the mental and social determinant of health impacts of a COVID-19 diagnosis, and 2) What are the impacts of a counseling program implemented to address those impacts? Participants will participate in individual interviews, attend individual and group counseling, and be provided resources related to their social determinants of health needs.

Type: Interventional

Start Date: Apr 2024

open study

The goal of this observational study is to determine the feasibility of conducting a large-scale study on the effect of using osteopathic manipulative treatment (OMT) to treat patients with post-COVID-19 symptoms. The main questions it aims to answer are: 1. Is it feasible to conduct a large-scale study of the effect of OMT on patients with post-COVID-19 symptoms (based on how many patients agree to participate and how many complete the study)? 2. How much change in patients' post-COVID-19 symptom severity, quality of life, and ability to return to work can we expect to see following OMT? Participants will receive OMT as directed by their physician and complete questionnaires after every other OMT session. 1. Participants will complete questionnaires about their post-COVID-19 symptoms, quality of life, ability to return to work, and adverse events they experienced 3 days after every other OMT session. 2. Participants will be sent links to the questionnaires for 4 months or when their symptoms resolve, whichever comes first. 3. Additionally, participants will complete a follow-up questionnaire 2 months after they stop receiving OMT for their post-COVID-19 symptoms or 6 months after enrollment in the study, whichever comes first.

Type: Observational

Start Date: Sep 2023

open study

The purpose of this study is to learn how Itraconazole affects the blood level of PF-07817883 in Healthy Adults. This study is seeking participants who are: - male and female aged 18 to 65 years old, - overtly healthy. This can be determined my medical evaluation, medical history, lab tests etc. This study will consist of 2 parts, Period 1 and Period 2. Period 1: participants will take PF-07817883 one time by mouth at the study clinic. Period 2: participants will take PF-07817883 one time by mouth at the study clinic. They will also take daily itraconazole by mouth for 7 days. Participants will stay at the study clinic for 2 weeks in total. The study doctors will collect blood and urine samples from everyone. The study doctors will check participants' reactions to the study medicine for safety measures. There is a follow-up call at 28 to 35 days from the last dose of PF-07817883. Itraconazole is an approved medicine. It is also a metabolism inhibitor. When taken with some medicines, it affects the actual level of these medicines in the body. This study will compare blood levels of PF-07817883 given with and without Itraconazole. This will help decide safety and right amount for PF-07817883 when given with metabolism inhibitors.

Type: Interventional

Start Date: Apr 2023

open study

Post-acute sequelae of SARS-CoV2 (PASC), colloquially known as "long-COVID," is thought to affect between 10-30% of all COVID-19 survivors. Patients with PASC also report worsening behavioral health symptoms over time that include new-onset depression, anxiety, and even suicidal behavior. The purpose of this randomized, double-blind, controlled trial is to test the efficacy of a glutamate modulator among PASC patients suffering from new-onset or worsening of depressive symptoms.

Type: Interventional

Start Date: Mar 2023

open study

This study is designed to test the efficacy and safety of combinations of two well-understood agents - famotidine and celecoxib. Each of these agents separately demonstrate clinical activity in mitigating COVID-19 disease symptoms or severity, and each of which appear to have separate and complementary mechanisms of action.

Type: Interventional

Start Date: Dec 2021

open study

This is randomized trial where households will be randomized to identify the optimal SARS-CoV-2 (COVID-19) testing modality in a population-representative sample of households in Baltimore City, Maryland. 1,386 households in Baltimore City will be randomized 1:1:1 to one of three testing modalities: 1) fixed-site standard of care testing; 2) community-based mobile van testing; or 3) self-collected home, based testing.

Type: Interventional

Start Date: Feb 2021

open study

Initial data from COVID-19 patients suggests that one of the primary causes of death is significant endothelial injury leading to blood clotting and impaired multiorgan microvascular perfusion. The current study uses a safe, convenient bedside imaging tool called contrast-enhanced ultrasound (CEUS) to estimate the extent of microvascular perfusion impairment in the heart, kidneys and/or brain of COVID-19 pediatric patients in vivo and assess the significance of imaging findings by correlating to clinical outcomes. This pilot study will be conducted at one site, The Children's Hospital of Philadelphia. The investigators plan to enroll and evaluate 30 patients.

Type: Interventional

Start Date: Dec 2020

open study

Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.

Type: Interventional

Start Date: May 2020

open study

The overall goal of this study is to find out if rehabilitation exercise can help people who have long COVID. Participants will be randomized by chance to receive either aerobic exercise or breathing exercise (combined with stretches). Participants will be guided and supported in completing a tailored, 6-week home exercise program to be performed 5 - 6 days a week, prescribed and supervised by rehabilitation therapists. Participants will perform breathing exercises, which will be supervised by an occupational therapist. The focus of Aim 1 is to determine feasibility of implementing RESToRE in long COVID.

Type: Interventional

Start Date: Oct 2023

open study

This is a phase 2/3, multicenter, randomized, placebo-controlled, observer-blind study assessing the safety, tolerability, immunogenicity, and efficacy of prophylactic hAd5-S-Fusion+N-ETSD against COVID-19. It is intended that a minimum of 25% of subjects will be in the >55-year stratum. Safety, immunogenicity, and efficacy assessments will be conducted per the Schedule of Events (SoE) and subjects are expected to participate for up to a maximum of approximately 2 years.

Type: Interventional

Start Date: Dec 2020

open study

The purpose of this study is to estimate the relative bioavailability of PF-07321332/ritonavir oral powder relative to the commercial tablet formulation under fasted condition in healthy adult participants. The study will also assess the effect of 3 different food vehicles on the relative bioavailability of the PF-07321332/ritonavir oral powder formulation as well as the safety, tolerability, and palatability of PF-07321332/ritonavir oral powder in healthy adult participants.

Type: Interventional

Start Date: Mar 2022

open study

To create and evaluate effective COVID-19 testing uptake strategies that focus on underserved individuals who are exposed but have not accessed testing, and underserved individuals who are not routinely tested because they are unaware of their exposure or risk status in order to increase testing among these populations and reduce Covid-19 related disparities.

Type: Interventional

Start Date: Oct 2020

open study

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

The purpose of this study is to determine the effect of sacubitril/valsartan versus placebo on markers of cardiac injury, structure, and function among patients who recovered from acute COVID-19 infection.

Type: Interventional

Start Date: Aug 2021

open study

The primary objective of this study is to evaluate the safety and efficacy of Xiflam versus Placebo in patients who present with signs and symptoms of Long COVID. Xiflam (n=10) or placebo (n=5) will be administered orally once a day (QD) for 12 weeks.

Type: Interventional

Start Date: Mar 2024

open study

The COVID-19 pandemic severely impacted the medical system both directly but also through incomplete recovery from the virus in the form of post-acute sequelae of COVID-19 (PASC). PASC affects at least 9.6 million individuals as of May 2022 and continues to affect many more. PASC is a multisystem disorder often presenting with mental fog, dyspnea on exertion, and fatigue among other symptoms. The etiology of PASC is uncertain but theories include direct cytotoxicity, dysregulated immune responses, endotheliitis associated with microthrombi, eNOS uncoupling, and myocardial fibrosis with impaired ventricular compliance. To date, there are no established treatments. Exercise has the potential as a therapeutic option to improve VO2peak and improve each of the aforementioned underlying etiologies. The investigators plan to examine the effect of High-Intensity Interval Training (HIIT) and Moderate intensity exercise training (MOD) on the symptoms and exercise tolerance of patients with PASC. The investigators approach will consist of a randomized, blinded, 2-arm, parallel-group design. Enrolled subjects will be randomly assigned to one of two groups in a 1:1 allocation ratio. All groups will undergo a 4-week intervention of 3 days of HIIT per week and 2 days of MOD per week or control of light stretching and controlled breathing. Subjects will be assessed before and after the 4-week intervention to examine the extent to which 4 weeks of the HIIT and MOD combination improves VO2peak and left ventricular diastolic function, global longitudinal strain (GLS), and global circumferential strain (GCS). Further, the investigators will explore changes in markers such as heart rate, heart rhythm, blood pressure, quality of life, exercise tolerance, and PASC symptoms as well as blood/serum markers.

Type: Interventional

Start Date: Sep 2023

open study

This study intends to describe the characteristics of patients given the Pfizer-BioNTech bivalent mRNA COVID-19 vaccine and any commercially available influenza vaccines at the same time versus at different times.

Type: Observational

Start Date: May 2023

open study

Long COVID patients experience high symptom burden for many months after initial infection of the COVID-19 virus. This study will investigate a mobile intervention Merging Yoga and Self-Management Skills (MY-Skills Mobile) as a complementary therapy for fatigue, pain, mood and quality of life in long COVID patients at the UCHealth Center for Integrative Medicine. The study aim is to assess the feasibility and acceptability of MY-Skills Mobile and research procedures including planned assessments.

Type: Interventional

Start Date: Feb 2023

open study

Oklahoma has high COVID-19 incidence, particularly among underserved minority and rural Oklahomans. Oklahoman's are also reporting SARS-CoV-2 vaccine hesitancy and signs of slowing vaccine uptake, with increased hesitancy among American Indian and rural populations. The project aims to work with ongoing community testing events to implement interventions to improve vaccine uptake among Oklahoma's underserved populations.

Type: Interventional

Start Date: Mar 2022

open study

This study uses a population-based approach to increase uptake of COVID-19 testing within a highly segregated and underserved African American community in Chicago.

Type: Interventional

Start Date: Mar 2021

open study