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EPIC-Peds: A Study to Learn About the Study Medicine Called PF-07321332 (Nirmatrelvir)/Ritonavir in1
Pfizer
COVID-19
The purpose of this clinical trial is to learn about the safety, pharmacokinetics
(pharmacokinetics helps us understand how the drug is changed and eliminated from your
body after you take it), and efficacy (how well a study treatment works in the study) of
the study medicine (called nirmatrelvir/r1 expand
The purpose of this clinical trial is to learn about the safety, pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it), and efficacy (how well a study treatment works in the study) of the study medicine (called nirmatrelvir/ritonavir) for potential treatment of coronavirus disease 2019 (COVID-19). The study medicine will be given to patients under 18 years of age with COVID-19 that are not hospitalized but are at risk for severe disease. Type: Interventional Start Date: Mar 2022 |
REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity1
Duke University
COVID-19
Critical Illness
ICU Acquired Weakness
PICS
Cardiorespiratory Fitness
Multicenter, prospective, randomized controlled trial providing mobile health supported
physical rehabilitation to 120 patients who have been critically ill with COVID-19 and
who complete at least one exercise session. expand
Multicenter, prospective, randomized controlled trial providing mobile health supported physical rehabilitation to 120 patients who have been critically ill with COVID-19 and who complete at least one exercise session. Type: Interventional Start Date: Feb 2023 |
Telehealth 2.0: Evaluating Effectiveness and Engagement Strategies for CPT-Text for PTSD
Stanford University
Posttraumatic Stress Disorder
There is a pressing need to increase capacity to treat PTSD related to or exacerbated by
the COVID-19 pandemic. Texting-based therapy holds promise to increase capacity and
reduce barriers to delivering evidence-based treatments (EBTs), but ongoing engagement in
digital mental health interventions1 expand
There is a pressing need to increase capacity to treat PTSD related to or exacerbated by the COVID-19 pandemic. Texting-based therapy holds promise to increase capacity and reduce barriers to delivering evidence-based treatments (EBTs), but ongoing engagement in digital mental health interventions is low. This study will compare a texting-based EBT for PTSD to culturally-informed texting-based treatment for PTSD as usual, and it will also compare a unique incentive strategy to typical platform reminders aimed to prevent early discontinuation in therapy. This online study is open to individuals who live in 13 different states. Type: Interventional Start Date: Mar 2022 |
Safety and Immunogenicity of RNA-based Vaccines Against SARS-CoV-2 Variants in Healthy Participants
BioNTech SE
SARS-CoV-2 Infection
COVID-19
SARS-CoV-2 Acute Respiratory Disease
SARS (Disease)
This trial consisted of three parts, Part A, Part B, and Part C, and evaluated the safety
and immunogenicity of a third (booster) injection of the multivalent vaccine BNT162b2
(B.1.1.7 + B.1.617.2), and the safety and immunogenicity of a third booster injection of
the monovalent vaccine BNT162b2 (B1 expand
This trial consisted of three parts, Part A, Part B, and Part C, and evaluated the safety and immunogenicity of a third (booster) injection of the multivalent vaccine BNT162b2 (B.1.1.7 + B.1.617.2), and the safety and immunogenicity of a third booster injection of the monovalent vaccine BNT162b2 (B.1.617.2) or BNT162b2 (B.1.1.7), in participants who had received two doses of the parent vaccine BNT162b2 at 30 µg, at least 6 months after the second dose of BNT162b2. It also evaluated the safety and immunogenicity of a three-dose regimen of BNT162b2 (B.1.1.7 + B.1.617.2) in participants who had not received prior Coronavirus Disease 2019 (COVID-19) vaccination. In addition, the safety and immunogenicity of BNT162b2 (B.1.1.529.1) or BNT162b2 given as a third or fourth vaccine dose to RNA COVID-19 vaccine-experienced participants with history of SARS-CoV-2 Omicron variant infection was evaluated and contrasted with the natural immune response reached after infection with the SARS-CoV-2 Omicron variant in RNA COVID-19 vaccine-experienced participants. Type: Interventional Start Date: Aug 2021 |
Piloting Virtual Reality Environments to Treat PTSD in Healthcare Workers
Weill Medical College of Cornell University
Posttraumatic Stress Disorder
Healthcare workers and COVID-19 patients may experience psychological distress consequent
to the pandemic, and are at particularly elevated risk for experiencing posttraumatic
stress disorder (PTSD), based on evidence from previous infectious disease outbreaks. The
best-validated treatment for PTSD1 expand
Healthcare workers and COVID-19 patients may experience psychological distress consequent to the pandemic, and are at particularly elevated risk for experiencing posttraumatic stress disorder (PTSD), based on evidence from previous infectious disease outbreaks. The best-validated treatment for PTSD is exposure therapy. Exposure therapy help patients suffering from PTSD to revisit and overcome their traumatic experiences. Including virtual reality in exposure therapy has a long history in treating PTSD; and has been used to treat military veterans and first-responders following 9/11. The investigators are developing and testing a virtual environment to treat PTSD including sub threshold PTSD symptoms in HCWs who experience occupational related trauma (e.g., working with COVID-19 patients) and COVID-19 patients. An independent evaluator will assess symptoms of PTSD and other psychopathology, using structured clinical interviews and self-report measures with well-established psychometric properties, at baseline, halfway through treatment, after completion of treatment, and at three-months post-treatment. Participants will complete ten ninety minute sessions (in-person or remotely), twice a week for five weeks aimed at mitigating their symptoms of PTSD. Remote participants will receive VR headsets after the baseline assessment and will keep them for the duration of the study. The pilot study will aim to demonstrate the feasibility and the tolerability of the virtual reality intervention in these populations. Type: Interventional Start Date: Oct 2023 |
To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pr1
BioNTech SE
SARS-CoV-2 Infection
COVID-19
Maternal Immunization
Results will be submitted, however please note that data are not yet available for all
serology outcome measures.
This will be a Phase 2/3, randomized, placebo-controlled, observer-blind study evaluating
the safety, tolerability, and immunogenicity of 30 µg of BNT162b2 or placebo administered
in 21 expand
Results will be submitted, however please note that data are not yet available for all serology outcome measures. This will be a Phase 2/3, randomized, placebo-controlled, observer-blind study evaluating the safety, tolerability, and immunogenicity of 30 µg of BNT162b2 or placebo administered in 2 doses, 21 days apart, in approximately 350 healthy pregnant women 18 years of age or older vaccinated at 24 to 34 weeks' gestation. Participants will be randomized 1:1 to receive BNT162b2 or placebo (saline). Type: Interventional Start Date: Feb 2021 |
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB05 +1
Edesa Biotech Inc.
COVID-19
ARDS
COVID-19 patients who develop severe disease often develop acute respiratory distress
syndrome (ARDS) as a result of a dysregulated immune response. This in turn stimulates a
pro-inflammatory cascade ("cytokine storm") as well as emergency myelopoiesis.
This proinflammatory cascade is activated wh1 expand
COVID-19 patients who develop severe disease often develop acute respiratory distress syndrome (ARDS) as a result of a dysregulated immune response. This in turn stimulates a pro-inflammatory cascade ("cytokine storm") as well as emergency myelopoiesis. This proinflammatory cascade is activated when viral-mediated cell damage occurs in the lungs, resulting in the release of damage-signaling alarmin molecules such as S100A8/A9 (Calprotectin), HMGB1, Resistin, and oxidized phospholipids. These damage-associated molecular patterns (DAMPs) are recognized by the pattern recognition receptor Toll-Like Receptor 4 (TLR4) found on macrophages, dendritic cells and other innate immune cells and result in additional release of pro-inflammatory molecules. Several recent studies have shown that S100A8/A9 serum levels in hospitalized COVID-19 patients positively correlate with both neutrophil count and disease severity. Taken together the DAMP-TLR4 interaction forms a central axis in the innate immune system and is a key driver of the pathological inflammation observed in COVID-19. We hypothesis that targeting the initial step in the signalling pathways of these DAMPs in innate immunity offers the best hope for controlling the exaggerated host response to SARS-CoV-2 infection. EB05 has demonstrated safety in two clinical studies (>120 patients) and was able to block LPS-induced (TLR4 agonist) IL-6 release in humans. Given, this extensive body of evidence we believe EB05 could ameliorate ARDS due to COVID-19, significantly reducing ventilation rates and mortality. Type: Interventional Start Date: Nov 2020 |
Impact of COVID-19 Pandemic on Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients with B1
M.D. Anderson Cancer Center
Breast Ductal Carcinoma in Situ
COVID-19 Infection
Hereditary Breast Carcinoma
Invasive Breast Carcinoma
This study investigates the impact of COVID-19 pandemic on out-of-pocket costs, lost
wages, and unemployment in patients with breast cancer undergoing breast surgery.
Post-mastectomy reconstructive patients are at high risk for financial toxicity (adverse
effects of escalating health care cost on w1 expand
This study investigates the impact of COVID-19 pandemic on out-of-pocket costs, lost wages, and unemployment in patients with breast cancer undergoing breast surgery. Post-mastectomy reconstructive patients are at high risk for financial toxicity (adverse effects of escalating health care cost on well-being). The goal of this study is to collect information about financial costs patients may have as a result of surgical treatment for cancer with or without breast reconstruction and to learn if COVID-19 affects patient costs of breast reconstruction. This may help researchers demonstrate the financial consequences of undergoing breast surgery. Type: Observational Start Date: May 2019 |
Natural History of Systemic and Nasal Mucosal Immunity to Influenza and SARS-CoV-2 in Adults After1
National Institute of Allergy and Infectious Diseases (NIAID)
Influenza
COVID-19
Background:
Influenza (flu) vaccinations are required for all NIH staff members who have direct
contact with patients. COVID-19 vaccines are recommended for persons 6 months of age and
older. Researchers want to learn about immunity in NIH staff members who get a flu and/or
COVID-19 vaccine.
Obje1 expand
Background: Influenza (flu) vaccinations are required for all NIH staff members who have direct contact with patients. COVID-19 vaccines are recommended for persons 6 months of age and older. Researchers want to learn about immunity in NIH staff members who get a flu and/or COVID-19 vaccine. Objective: To understand what happens to the body s immune system throughout the year after getting the flu and/or COVID-19 vaccine. Eligibility: Adults ages 18 and older who work at NIH and plan to get the current season s flu vaccine and/or COVID-19 vaccine. Design: Participants will not get any vaccines as part of this study. Participants will be screened with a medical history and medicine review. They will get a survey via email. It will ask about their flu and SARS-CoV-2 history and vaccinations. Participants will have 12 monthly visits at NIH. If during that year they get both flu and SARS-COV-2 vaccines, their participation will be extended. Once a month, participants will be contacted. They will discuss any new medicines, recent vaccinations, or changes in medical history. Once a month, participants will have blood drawn. Once a month, participants will have nasal sampling. A small, flat absorptive strip will be placed in the nostril to soak up mucus. Participants will press against the outside of their nostril with their finger for 1 minute. Participants may be able to collect samples at home and mail them to NIH if they are not able to visit in person. Participation will last for about 12 13 months. Type: Observational Start Date: Aug 2021 |
Probiotic Use for Recovery Enhancement from Long COVID-19
Rush University Medical Center
Post-Acute COVID-19 Syndrome
The goal of this clinical trial is to learn if probiotics can improve symptoms and
quality of life in participants with Long COVID. The main questions it aims to answer
are:
1. Do probiotics reduce the number and severity of symptoms in those with Long COVID?
2. Do probiotics improve physical1 expand
The goal of this clinical trial is to learn if probiotics can improve symptoms and quality of life in participants with Long COVID. The main questions it aims to answer are: 1. Do probiotics reduce the number and severity of symptoms in those with Long COVID? 2. Do probiotics improve physical and mental health quality of life in those with Long COVID? 3. Do probiotics improve return to work and daily activities in those with Long COVID? Researchers will compare probiotics to a placebo (a look-alike substance that contains no probiotics) to see if probiotics works to treat Long COVID. Participants will take the study medication (placebo or probiotic) for 4 months. They will then cross-over (take the other medication) for an additional 4 months. Participants will complete a survey at baseline, 4 months, and 8 months. Type: Interventional Start Date: Dec 2024 |
Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Pos1
CSL Behring
Post-COVID Postural Orthostatic Tachycardia Syndrome
This is a prospective, phase 3, multicenter, double-blind, randomized placebo-controlled
study to investigate the efficacy, safety, and pharmacokinetics (PK) of repeat doses of
IgPro20 in participants with post SARS-CoV-2 infection 2019 postural orthostatic
tachycardia syndrome (post-Coronavirus Di1 expand
This is a prospective, phase 3, multicenter, double-blind, randomized placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics (PK) of repeat doses of IgPro20 in participants with post SARS-CoV-2 infection 2019 postural orthostatic tachycardia syndrome (post-Coronavirus Disease 2019 [COVID-19] POTS [post-COVID-POTS]). Type: Interventional Start Date: Aug 2024 |
RECOVER-ENERGIZE Platform Protocol
Duke University
Long COVID
Long Covid19
Long Covid-19
This is a platform protocol designed to be flexible so that it is suitable for a range of
interventions and settings within diverse health care systems and community settings with
incorporation into clinical COVID-19 management programs and treatment plans if results
achieve key study outcomes.
Th1 expand
This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). The focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC. Type: Interventional Start Date: Jul 2024 |
Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19
MaxWell Clinic, PLC
Long COVID
The Primary objective of this study is to determine, using unblinded samples, if it is
possible to develop an algorithm for the classification of specific blood RNA from
patients with long COVID together and separately from the apparent health normal controls
and other medical conditions that share1 expand
The Primary objective of this study is to determine, using unblinded samples, if it is possible to develop an algorithm for the classification of specific blood RNA from patients with long COVID together and separately from the apparent health normal controls and other medical conditions that share the signs and symptoms of long COVID. Type: Interventional Start Date: Mar 2024 |
Lithium Long COVID Dose-finding Study
State University of New York at Buffalo
Long COVID
This open-label study will assess if lithium dosages of 30-45mg/day are associated with
greater symptomatic benefit than dosages of 10-15mg/day previously assessed among 50
patients with long COVID. expand
This open-label study will assess if lithium dosages of 30-45mg/day are associated with greater symptomatic benefit than dosages of 10-15mg/day previously assessed among 50 patients with long COVID. Type: Interventional Start Date: Oct 2023 |
Additional Recombinant COVID-19 Humoral and Cell-Mediated Immunogenicity in Immunosuppressed Popula1
University of Wisconsin, Madison
Immunosuppression
COVID-19
To determine whether providing a recombinant booster COVID-19 vaccine improves sustained
humoral and cell-mediated immunogenicity against SARS-CoV-2 in immunosuppressed patients
with Inflammatory Bowel Disease (IBD) and/or solid organ transplant recipients. 120
participants will be enrolled and can1 expand
To determine whether providing a recombinant booster COVID-19 vaccine improves sustained humoral and cell-mediated immunogenicity against SARS-CoV-2 in immunosuppressed patients with Inflammatory Bowel Disease (IBD) and/or solid organ transplant recipients. 120 participants will be enrolled and can expect to be on study for 6 months. Type: Interventional Start Date: Nov 2023 |
Phase I Safety Study of B/HPIV3/S-6P Vaccine Via Nasal Spray in Adults
National Institute of Allergy and Infectious Diseases (NIAID)
SARS-CoV-2 Infection
This Phase 1 clinical trial will evaluate the safety and immunogenicity of an intranasal
vaccine candidate, a recombinant, live-attenuated, bovine/human parainfluenza virus
vector vaccine expressing the 6-P prefusion-stabilized version of the SARS-CoV-2 spike
protein. expand
This Phase 1 clinical trial will evaluate the safety and immunogenicity of an intranasal vaccine candidate, a recombinant, live-attenuated, bovine/human parainfluenza virus vector vaccine expressing the 6-P prefusion-stabilized version of the SARS-CoV-2 spike protein. Type: Interventional Start Date: Sep 2023 |
Evaluation of the RD-X19 Treatment Device in Individuals With Mild COVID-19
EmitBio Inc.
COVID-19
This is a randomized, double-blind, sham controlled, stratified, pivotal efficacy and
safety study of the EmitBio RD-X19 treatment device in Individuals 40 Years of age and
older with Mild COVID-19 in the at-home setting. expand
This is a randomized, double-blind, sham controlled, stratified, pivotal efficacy and safety study of the EmitBio RD-X19 treatment device in Individuals 40 Years of age and older with Mild COVID-19 in the at-home setting. Type: Interventional Start Date: Apr 2023 |
Efficacy and Safety Study of Efgartigimod in Adults with Post-COVID-19 POTS
argenx
Postural Orthostatic Tachycardia Syndrome
The study aims to investigate the safety, tolerability, efficacy, pharmacodynamics (PD),
pharmacokinetics (PK), and immunogenicity of efgartigimod compared to placebo in
participants with post-COVID-19 postural orthostatic tachycardia syndrome (POTS)
(post-COVID-19 POTS). expand
The study aims to investigate the safety, tolerability, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod compared to placebo in participants with post-COVID-19 postural orthostatic tachycardia syndrome (POTS) (post-COVID-19 POTS). Type: Interventional Start Date: Sep 2022 |
RECOVER-VITAL: Platform Protocol to Measure the Effects of Antiviral Therapies on Long COVID Sympto1
Kanecia Obie Zimmerman
Long COVID
Long Covid19
This study is a platform protocol designed to be flexible so that it is suitable for a
wide range of settings within health care systems 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-ar1 expand
This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems 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, double-blind, randomized, controlled platform trial with different interventions organized as appendices to the protocol. Each appendix (or sub-study) evaluates potential mechanisms of action, efficacy, and safety of antivirals and other therapeutics in individuals with PASC, according to the platform protocol objectives. The hypothesis is that persistent viral infection, viral reactivation, and/or overactive/chronic immune response and inflammation are underlying contributors to PASC and that antiviral and other applicable therapies may result in viral clearance or decreased inflammation and improvement in PASC symptoms. Type: Interventional Start Date: Jul 2023 |
A Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVI1
Pfizer
COVID-19
The purpose of this clinical trial is to learn about how study medicine (Paxlovid, which
contains nirmatrelvir and ritonavir) is changed and eliminated from the body, as well as
its safety, and the extent to which side effects can be tolerated for treatment of
pregnant women with mild or moderate C1 expand
The purpose of this clinical trial is to learn about how study medicine (Paxlovid, which contains nirmatrelvir and ritonavir) is changed and eliminated from the body, as well as its safety, and the extent to which side effects can be tolerated for treatment of pregnant women with mild or moderate COVID-19 compared to non-pregnant women with mild or moderate COVID-19. This study is seeking participants who: - are expecting a healthy baby and are in their second or third trimester pregnancy and have mild or moderate COVID-19 - are not pregnant and have mild or moderate COVID-19. All participants in this study will take Paxlovid by mouth every 12 hours for 5 days. We will study the experiences of people receiving the study medicine. This will help us decide if the study medicine is safe. All participants will take part in this study for at least 34 days; pregnant participants will take part until their delivery, so that the study duration may be up to 6 months, depending on their delivery date. During this time, participants will have 7to 8 visits and, if pregnant, a visit at delivery. Around 2 to 3 visits and the delivery visit will be done in person (at the clinic or at the participant's home). The other 5 visits may be done over the phone, unless in-person visit is necessary as decided by the doctor. Blood samples will be collected on the first 4 to 5 study visits (and at other study visits, if necessary). Type: Interventional Start Date: Jun 2022 |
Mindfulness Intervention for Post-Covid Symptoms
Mayo Clinic
COVID-19
Post Acute Sequelae of SARS-CoV-2
The purpose of this research is to study if post-Covid patients using a wearable brain
sensing wellness device (Muse-S) to learn meditation practice during a time where they
are experiencing lengthy Covid symptoms will help in decreasing stress and anxiety. expand
The purpose of this research is to study if post-Covid patients using a wearable brain sensing wellness device (Muse-S) to learn meditation practice during a time where they are experiencing lengthy Covid symptoms will help in decreasing stress and anxiety. Type: Interventional Start Date: Jun 2022 |
Study to Evaluate Pharmacokinetic Comparability Between AZD7442 Co-formulation (AZD8895 + AZD1061)1
AstraZeneca
Corona Virus Disease
The study will assess pharmacokinetic (PK) comparability between different formulations
of AZD7442, which is a combination of two individual monoclonal antibodies (mAbs),
AZD8895 and AZD1061. expand
The study will assess pharmacokinetic (PK) comparability between different formulations of AZD7442, which is a combination of two individual monoclonal antibodies (mAbs), AZD8895 and AZD1061. Type: Interventional Start Date: Nov 2021 |
Safety of Pediatric COVID-19 Vaccination
Duke University
Pain
Injection Site Reaction
Adverse Drug Event
This is a prospective, observational study. During the study, children and adolescents
(ages ≥ 5 to < 16) will be followed post administration of mRNA COVID-19 vaccines.
Injection site (local), systemic reaction, and unsolicited adverse event data will be
assessed on vaccination day and during the1 expand
This is a prospective, observational study. During the study, children and adolescents (ages ≥ 5 to < 16) will be followed post administration of mRNA COVID-19 vaccines. Injection site (local), systemic reaction, and unsolicited adverse event data will be assessed on vaccination day and during the 7 days following each vaccination using either identical web-based or paper diaries, depending on study participant preference. At Duke University, Cincinnati's Children Hospital, and Kaiser Permanente Northern California, serum samples will be collected for optional assessment of antibody titers to COVID-19. Each participant who opts in will have baseline (within 3 days of vaccination) serologies obtained and immunogenicity assessment at 28 (+7) days after each dose. All participants will be followed for 180 days after dose 2 for serious adverse events and adverse events of special interest. Type: Observational Start Date: Apr 2022 |
Patient Perceptions of the Relational Empathy of Healthcare Practitioners From the Department of Em1
M.D. Anderson Cancer Center
COVID-19 Infection
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
This study investigates patients' perceptions of their doctor's or nurse's empathy during
an in-person interaction with the doctor or nurse wearing personal protective equipment
(PPE) compared to during a video interaction with the doctor or nurse without PPE. The
goal of this research study is to1 expand
This study investigates patients' perceptions of their doctor's or nurse's empathy during an in-person interaction with the doctor or nurse wearing personal protective equipment (PPE) compared to during a video interaction with the doctor or nurse without PPE. The goal of this research study is to learn whether patients who visit the Acute Cancer Care Center at MD Anderson believe they get better (more empathetic) care from doctors who visit them in person wearing PPE or from doctors who visit them by video call and do not wear PPE. Type: Observational Start Date: Jun 2021 |
Study Assessing the Feasibility, Safety and Efficacy of Genetically Engineered Glucocorticoid Recep1
M.D. Anderson Cancer Center
Adenovirus Infection
BK Virus Infection
Cytomegaloviral Infection
Hematopoietic and Lymphoid Cell Neoplasm
JC Virus Infection
This phase I trial tests the feasibility and safety of genetically modified cytotoxic
T-lymphocytes in controlling infections caused by adenovirus (ADV), BK virus (BKV),
cytomegalovirus (CMV), JC virus (JCV), or COVID-19 in immunocompromised patients with
cancer. Viral infections are a leading caus1 expand
This phase I trial tests the feasibility and safety of genetically modified cytotoxic T-lymphocytes in controlling infections caused by adenovirus (ADV), BK virus (BKV), cytomegalovirus (CMV), JC virus (JCV), or COVID-19 in immunocompromised patients with cancer. Viral infections are a leading cause of morbidity and mortality after hematopoietic stem cell transplantation, and therapeutic options for these infections are often complicated by associated toxicities. Genetically modified cytotoxic T-lymphocytes (CTLs) are designed to kill a specific virus that can cause infections. Depending on which virus a patient is infected with (ADV, BKV, CMV, JCV, or COVID-19), the CTLs will be designed to specifically attack that virus. Giving genetically modified CTLs may help to control the infection. Type: Interventional Start Date: Jan 2023 |
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