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Baby2Home (B2H) Mobile Health Application
Women and Infants Hospital of Rhode Island
COVID-19 Pandemic
Health Knowledge, Attitudes, Practice
Perinatal Depression
Mental Health Wellness
Post Partum Depression
The COVID-19 pandemic has transformed healthcare delivery; arguably, the fields of
obstetrics and pediatrics have experienced some of the greatest changes as they have
transitioned away from their role as a medical home and into more of an urgent care model
of care. Baby2Home is a digital health intervention... expand
The COVID-19 pandemic has transformed healthcare delivery; arguably, the fields of obstetrics and pediatrics have experienced some of the greatest changes as they have transitioned away from their role as a medical home and into more of an urgent care model of care. Baby2Home is a digital health intervention designed to bridge the resultant gaps in obstetrics and pediatrics healthcare services for new families over the first year of life. This randomized controlled trial will evaluate whether, compared to usual care, Baby2Home 1) improves maternal, paternal, and infant health service utilization outcomes over the first year postpartum, 2) improves maternal and paternal patient reported outcomes, and 3) reduces racial/ethnic and income-based disparities in preventive health services utilization and parental patient reported outcomes. Type: Interventional Start Date: Nov 2022 |
A Study to Learn About a Repeat 5-Day Treatment With the Study Medicines (Called Nirmatrelvir/Ritonavir)...
Pfizer
COVID-19
The purpose of this study is to learn about the safety and effects of
nirmatrelvir/ritonavir for the potential treatment of COVID-19 rebound.
The study is seeking participants who:
- Have completed treatment with nirmatrelvir/ritonavir
- Have a rebound in COVID-19 symptoms
- Are... expand
The purpose of this study is to learn about the safety and effects of nirmatrelvir/ritonavir for the potential treatment of COVID-19 rebound. The study is seeking participants who: - Have completed treatment with nirmatrelvir/ritonavir - Have a rebound in COVID-19 symptoms - Are SARS-CoV-2 (COVID-19) positive All study medications will be taken 2 times a day by mouth for 5 days. The first dose of study medication is taken at the study clinic and the rest at home. We will examine the experiences of people receiving the study medicines to those who do not. This will help us determine if the study medicines are safe and effective. People taking part will be in this study for about 24 weeks. Enrolled participants will need to visit the study clinic at least 8 times during the study. Type: Interventional Start Date: Oct 2022 |
A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older...
Pfizer
COVID-19
The purpose of this clinical trial is to learn about the safety and effects of the study
medicine (called Nirmatrelvir/Ritonavir) for the possible treatment of COVID-19.
Patients with COVID-19 who have more difficulty in fighting against infections have a
higher chance of severe illness. Such patients... expand
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Nirmatrelvir/Ritonavir) for the possible treatment of COVID-19. Patients with COVID-19 who have more difficulty in fighting against infections have a higher chance of severe illness. Such patients may benefit from longer treatment durations compared to the standard treatment regimen. The study is seeking participants who: - Have a confirmed COVID-19 infection - Are Immunocompromised - Experience onset of signs/symptoms attributable to the current COVID-19 infection within 5 days prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization. In addition, this study will also evaluate the efficacy and safety of a second treatment course of nirmatrelvir/ritonavir in people who experience that their COVID-19 is flaring up within 14 days of having taken a 5-day treatment course of nirmatrelvir/ritonavir. For this group, the study is seeking participants who: - Have a confirmed COVID-19 infection - Experience a worsening of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir - The worsening of COVID-19 symptoms must occur within 14 days after completion of the initial 5-day course of nirmatrelvir/ritonavir - Are Immunocompromised - Experience onset of signs/symptoms attributable to the current COVID-19 infection within 48 hours prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization. All participants will be taking the study medicine for either 5, 10, or 15 days. The study medication will be taken by mouth 2 times a day. Participants will take part in this study for about 24 weeks. The first dose of study medication is taken at the study site and the rest at home. Selected participants will need to visit the study site at least 10 times during the study. Type: Interventional Start Date: Aug 2022 |
IMM-BCP-01 in Mild to Moderate COVID-19
Immunome, Inc.
SARS-CoV2 Infection
COVID-19
The primary objective of this study is to evaluate the safety and tolerability of
intravenous (IV) IMM-BCP-01 in subjects with mild to moderate COVID-19 through Day 28.
The secondary objectives of the study are to:
- Determine pharmacokinetics (PK) and evaluate viral clearance after single... expand
The primary objective of this study is to evaluate the safety and tolerability of intravenous (IV) IMM-BCP-01 in subjects with mild to moderate COVID-19 through Day 28. The secondary objectives of the study are to: - Determine pharmacokinetics (PK) and evaluate viral clearance after single ascending doses of IV IMM-BCP-01 in subjects with mild to moderate COVID-19 through Day 28. - Evaluate the safety and tolerability, determine PK, and evaluate viral clearance of single ascending doses of IV IMM-BCP-01 in subjects with mild to moderate COVID-19 through Week 12. Type: Interventional Start Date: Jun 2022 |
Safety and Effectiveness of Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells in Moderate...
Vitti Labs, LLC
COVID-19 Acute Respiratory Distress Syndrome
Respiratory Distress Syndrome
Recent advances have been made in prevention of the viral infection via vaccines but
there is still need for effective treatment options for patients. Novel therapies need to
be developed to further improve clinical outcomes. The biggest medical challenge in the
response to COVID-19 is ARDS requiring... expand
Recent advances have been made in prevention of the viral infection via vaccines but there is still need for effective treatment options for patients. Novel therapies need to be developed to further improve clinical outcomes. The biggest medical challenge in the response to COVID-19 is ARDS requiring hospitalization in an intensive care setting and ventilator dependence. Intravenously administered umbilical cord derived exosomes and stem cells have been reported in literature to alleviate pulmonary distress in such patients. The purpose of this study is to explore the safety and benefits of intravenous administration of WJPure and EVPure in the treatment of COVID-19 patients with moderate to severe ARDS. . Type: Interventional Start Date: Mar 2025 |
Pilot Study of Vitamin K2 (MK-7) and Vitamin D3 Supplementation and the Effects on PASC Symptomatology...
University Hospitals Cleveland Medical Center
Post-acute COVID-19 Syndrome
Participants are being asked to take part in this research study because they have had a
previous diagnosis (at least 3 months ago) of COVID-19 and are experiencing persistent,
recurrent or even new symptoms, i.e. post-acute sequelae of SARS-CoV-2 (PASC). The
Investigators are interested in studying... expand
Participants are being asked to take part in this research study because they have had a previous diagnosis (at least 3 months ago) of COVID-19 and are experiencing persistent, recurrent or even new symptoms, i.e. post-acute sequelae of SARS-CoV-2 (PASC). The Investigators are interested in studying the effects of Vitamin K2 (MK-7) and Vitamin D3 supplementation on PASC symptoms and the underlying inflammatory process. Type: Interventional Start Date: Jun 2022 |
In Utero Exposure to SARS-CoV-2 (COVID-19) and Cardiovascular and Metabolic Endpoints in Early Life
Massachusetts General Hospital
In Utero SARS-CoV-2 Exposure
Since its initial outbreak in late 2019, coronavirus disease 2019 (COVID-19) caused by
the novel coronavirus SARS-CoV-2 has ravaged the globe, causing illness characterized by
inflammation and impaired oxygen levels. As a particularly vulnerable group, pregnant
women have had a heightened prevalence... expand
Since its initial outbreak in late 2019, coronavirus disease 2019 (COVID-19) caused by the novel coronavirus SARS-CoV-2 has ravaged the globe, causing illness characterized by inflammation and impaired oxygen levels. As a particularly vulnerable group, pregnant women have had a heightened prevalence and severity of infection. In this context, a new population of children has emerged who were exposed to maternal COVID-19 in the womb. As maternal diseases during pregnancy may impact the health of offspring over the life course, health outcomes among these individuals must be urgently evaluated. In the current study, the investigators will leverage a perinatal biorepository comprised of pregnant women with and without COVID-19 to delineate the metabolic and cardiovascular risk profiles of these offspring. This work stands to benefit the burgeoning population of children exposed to COVID-19 in the womb and to deepen the mechanistic understanding of developmental origins of cardiometabolic disease with respect to maternal infections. Type: Observational Start Date: Jun 2021 |
Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 Acute Respiratory Distress...
University of Minnesota
Covid19
SARS-CoV Infection
ARDS
ARDS, Human
Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patients
on mechanical ventilation. expand
Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patients on mechanical ventilation. Type: Interventional Start Date: Jan 2025 |
Trial of Combination Therapy to Treat COVID-19 Infection
ProgenaBiome
COVID
Covid-19
Corona Virus Infection
Coronavirus Infection
Coronavirus-19
In this trial patients will be treated with either a combination of therapies to treat
COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6
months. expand
In this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months. Type: Interventional Start Date: Dec 2020 |
A Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection
ProgenaBiome
COVID-19
Coronavirus Infection
Sars-CoV2
Corona Virus Infection
COVID
This is a Phase II interventional study testing whether treatment with
hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19 expand
This is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19 Type: Interventional Start Date: Jun 2020 |
Cardiopulmonary Exercise Tests in Patients With Long COVID
Sheffield Hallam University
Long COVID
COVID Long-Haul
The value of clinical cardiopulmonary exercise testing (CPET) within healthcare settings
has been established in the last decade. CPET methods remain highly relevant in the
COVID-19 endemic phase and should be used to assess those recovering from COVID-19
(SARS-CoV-2) infection. This diagnostic tool... expand
The value of clinical cardiopulmonary exercise testing (CPET) within healthcare settings has been established in the last decade. CPET methods remain highly relevant in the COVID-19 endemic phase and should be used to assess those recovering from COVID-19 (SARS-CoV-2) infection. This diagnostic tool could play an integral role in disease prognostication and evaluate the integrative response to incremental exercise. Date from such assessments can enable practitioners to characterise cardio-respiratory fitness and identify reasons for physical impairment or abnormal cardio-respiratory function. More than 50% of patients admitted to hospital will experience cardiorespiratory issues and significant morbidity during their recovery and will require significant rehabilitative support. In this context, measurements obtained from an assessment of cardio-respiratory responses to physiological stress could provide insight regarding the integrity of the pulmonary-vascular interface and characterisation of any impairment or abnormal cardio-respiratory function. Current approaches to rehabilitation are being developed on existing knowledge from Severe Acute Respiratory Syndrome (SARS) and Acute Respiratory Distress Syndrome (ARDS) related illness. These provide important insight but do not provide insight into the novel challenges provided by COVID-19. Type: Observational Start Date: Mar 2023 |
Xofluza-Wearables Feasibility-Study
Children's Hospital of Philadelphia
Infection, Coronavirus
Infections
Influenza
Transplant
Infection Viral
The goal of this prospective, interventional, single-center study is to assess whether
the early detection of Influenza with smartwatch algorithms and alerting, rapid testing,
and subsequent Baloxavir treatment demonstrate better post-infection outcomes versus
publicly available- and Centers for Disease... expand
The goal of this prospective, interventional, single-center study is to assess whether the early detection of Influenza with smartwatch algorithms and alerting, rapid testing, and subsequent Baloxavir treatment demonstrate better post-infection outcomes versus publicly available- and Centers for Disease Control (CDC)-derived national statistics for equivalent household populations as well as pediatric kidney, heart, liver, lung transplant recipients and waitlisted patients. Type: Interventional Start Date: Dec 2023 |
RECOVER-NEURO: Platform Protocol to Measure the Effects of Cognitive Dysfunction Interventions on Long...
Duke University
Long COVID
Long Covid19
Long Covid-19
This platform protocol is designed to be flexible so that it is suitable for a wide range
of settings within health care systems, for remote settings, and in community settings
where it can be integrated into COVID-19 programs and subsequent treatment plans.
This protocol is a prospective, multi-center,... expand
This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within health care systems, for remote settings, and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating potential interventions for PASC-mediated cognitive dysfunction. The hypothesis is that PASC associated dysfunction in cognitive domains, such as executive function and attention, may be improved by interventions that selectively focus on enhancing those domains. Type: Interventional Start Date: Sep 2023 |
RECOVER-NEURO: Platform Protocol, Appendix_A to Measure the Effects of BrainHQ, PASC CoRE and tDCS Interventions...
Duke University
Long COVID
Long Covid19
Long Covid-19
This platform protocol is designed to be flexible so that it is suitable for a wide range
of settings within health care systems, for remote settings, and in community settings
where it can be integrated into COVID-19 programs and subsequent treatment plans.
This protocol is a prospective, multi-center,... expand
This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within health care systems, for remote settings, and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating potential interventions for PASC-mediated cognitive dysfunction. The hypothesis is that PASC-associated dysfunction in cognitive domains, such as executive function and attention, may be improved by interventions that selectively focus on enhancing those domains. This design seeks to evaluate each intervention relative to the Active Comparator. The BrainHQ (alone) arm is important because the intervention is commercially available, accessible, relatively inexpensive, and does not require trained personnel to administer. BrainHQ has been also been proven effective in other studies of cognitive dysfunction such as studies in aging, mild cognitive impairment, traumatic brain injury, among others. The BrainHQ + PASC CoRE arm and the BrainHQ + tDCS arms are suspected to provide cognitive improvements beyond BrainHQ alone through different mechanisms. Both PASC CoRE and tDCS have extensive prior use and have demonstrated utility in improving aspects of cognitive function in other clinical settings.. Type: Interventional Start Date: Sep 2023 |
Sauna for Long Covid
Massachusetts General Hospital
Long COVID
Research suggests that Whole Body Hyperthermia in a sauna-like environment can reduce
symptoms related to post-acute sequelae of SARS-CoV-2 (PASC), or Long Covid. The
investigators aim to study the feasibility and treatment effect of this procedure for
patients experiencing Long Covid symptoms. expand
Research suggests that Whole Body Hyperthermia in a sauna-like environment can reduce symptoms related to post-acute sequelae of SARS-CoV-2 (PASC), or Long Covid. The investigators aim to study the feasibility and treatment effect of this procedure for patients experiencing Long Covid symptoms. Type: Interventional Start Date: Sep 2024 |
Long-Term Sequelae of SARS-COV-2 Infection: Diabetes Mellitus
The University of Texas Health Science Center at San Antonio
COVID-19
Diabete Mellitus
Hospitalized patients with severe COVID-19 have an increased incidence of insulin
resistance, impaired beta cell function, glucose intolerance (prediabetes), and overt
type 2 diabetes (T2D) compared to non-hospitalized patients with COVID-19 and COVID-19
negative individuals on long-term follow up. expand
Hospitalized patients with severe COVID-19 have an increased incidence of insulin resistance, impaired beta cell function, glucose intolerance (prediabetes), and overt type 2 diabetes (T2D) compared to non-hospitalized patients with COVID-19 and COVID-19 negative individuals on long-term follow up. Type: Observational Start Date: Jul 2023 |
The Impact of Chiropractic on Long COVID-19
Life University
Long COVID
The purpose of this waitlist-controlled, single-blind, one-way crossover, pilot trial is
to evaluate the potential effects of ~8 weeks of chiropractic care on patient-reported
fatigue and the autonomic nervous system in adults with long COVID. This study will allow
us to estimate the standard deviation... expand
The purpose of this waitlist-controlled, single-blind, one-way crossover, pilot trial is to evaluate the potential effects of ~8 weeks of chiropractic care on patient-reported fatigue and the autonomic nervous system in adults with long COVID. This study will allow us to estimate the standard deviation of the primary endpoint in our population with which a formal power calculation for a future randomized, controlled trial can be performed. Type: Interventional Start Date: Jan 2025 |
A Decentralized, Randomized Phase 2 Efficacy and Safety Study of Nirmatrelvir/Ritonavir in Adults with...
Harlan M Krumholz
Long COVID
This decentralized trial is a Phase 2, 1:1 randomized, double-blind, superiority,
placebo-controlled study in an anticipated 100 non-hospitalized highly symptomatic adult
participants with long COVID. It seeks to determine the efficacy, safety, and
tolerability of 15 days of Paxlovid (nirmatrelvir/ritonavir),... expand
This decentralized trial is a Phase 2, 1:1 randomized, double-blind, superiority, placebo-controlled study in an anticipated 100 non-hospitalized highly symptomatic adult participants with long COVID. It seeks to determine the efficacy, safety, and tolerability of 15 days of Paxlovid (nirmatrelvir/ritonavir), an anti-viral agent, compared with placebo plus ritonavir. The hypothesis is that viral persistence contributes to long COVID in some patients and nirmatrelvir/ritonavir compared with placebo/ritonavir can improve general health status in participants with long COVID. The study will also seek immune signatures associated with treatment response (overseen by Professor Akiko Iwasaki). The decentralized study does not require site visits, and participants in all 48 states including the District of Columbia, who meet entry criteria can enroll. It is designed to make it convenient to participate. The study drugs will be delivered to the participant's designated address. Long COVID is also known as post-acute sequelae of SARS-CoV-2 (PASC). Type: Interventional Start Date: Apr 2023 |
Pain in Long COVID-19: The Role of Sleep
Beth Israel Deaconess Medical Center
Long COVID
Pain is among the most frequently reported symptoms in Long COVID, along with sleep
disturbances, fatigue, and cognitive impairments. Sleep plays a critical role in
maintaining a pain-free state. The goal of this study is to characterize the type and
severity of pain in Long COVID, to characterize... expand
Pain is among the most frequently reported symptoms in Long COVID, along with sleep disturbances, fatigue, and cognitive impairments. Sleep plays a critical role in maintaining a pain-free state. The goal of this study is to characterize the type and severity of pain in Long COVID, to characterize sleep and sleep disturbances in Long COVID, and to understand the role of sleep in the development and persistence of pain symptoms in Long COVID. Type: Observational Start Date: Oct 2022 |
A Safety and Tolerability Study of Sotrovimab (VIR-7831) Prophylaxis Against COVID-19 in Immunocompromised...
Sophia Koo, M.D.
SARS CoV 2 Infection
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. expand
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 |
Frontline Clinician Psilocybin Study
University of Washington
Burnout, Caregiver
Burnout, Professional
COVID-19
Depression
Post Traumatic Stress Disorder
This study aims to investigate the effects of a single dose of psilocybin, delivered in
the contextof pre- and post-dose psychotherapy, on symptoms of depression and burnout
suffered by healthcare clinicians as a result of frontline work in the COVID pandemic. expand
This study aims to investigate the effects of a single dose of psilocybin, delivered in the contextof pre- and post-dose psychotherapy, on symptoms of depression and burnout suffered by healthcare clinicians as a result of frontline work in the COVID pandemic. Type: Interventional Start Date: Mar 2022 |
A Study of Acute Respiratory Infections in Global Outpatient Setting
Janssen Research & Development, LLC
Acute Respiratory Infection
The purpose of this study is to evaluate the positivity rate of respiratory syncytial
virus (RSV), influenza virus and severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) in high-risk participants presenting with acute respiratory infections
(ARIs) in outpatient settings during the influenza/RSV... expand
The purpose of this study is to evaluate the positivity rate of respiratory syncytial virus (RSV), influenza virus and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in high-risk participants presenting with acute respiratory infections (ARIs) in outpatient settings during the influenza/RSV season and to evaluate the association between lower respiratory tract disease (LRTD) and ARI-related hospitalization in participants positive for RSV. Type: Interventional Start Date: Dec 2021 |
A Trial of the Safety and Immunogenicity of the COVID-19 Vaccine (mRNA-1273) in Participants With Hematologic...
National Cancer Institute (NCI)
Solid Tumor Malignancy
Hematologic Malignancy
Leukemia
Lymphoma
Multiple Myeloma
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... expand
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 |
Prophylaxis and Treatment of COVID-19
Henry M. Jackson Foundation for the Advancement of Military Medicine
COVID-19
Acute Respiratory Infection
An observation study evaluating physiologic responses and host biomarker expression
patterns in early SARS-CoV-2 and acute respiratory infections (ARI) and among their close
contacts. expand
An observation study evaluating physiologic responses and host biomarker expression patterns in early SARS-CoV-2 and acute respiratory infections (ARI) and among their close contacts. Type: Observational Start Date: Jun 2021 |
A Study of Risk Factors for the COVID-19 Virus Infection
Memorial Sloan Kettering Cancer Center
COVID-19 Infections in Cancer Patients
The purpose of this study is to collect information that will help the reasearchers learn
more about COVID-19 infections in cancer patients, and to find out about the effects of
these infections on cancer treatment and outcomes. The research study involves asking
people to complete a series of online... expand
The purpose of this study is to collect information that will help the reasearchers learn more about COVID-19 infections in cancer patients, and to find out about the effects of these infections on cancer treatment and outcomes. The research study involves asking people to complete a series of online questionnaires that include questions about their medical history, lifestyle, and risk factors related to the COVID-19 infection. The study will enroll both MSK patients and their household family members. Type: Observational Start Date: Dec 2020 |
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