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Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated...
Imunon
SARS CoV 2 Infection
This is an open-label phase 1/2, dose-escalation study. Participants will receive a single
intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle and will be followed
through 12 months post-vaccination (through Study Day 365).
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This is an open-label phase 1/2, dose-escalation study. Participants will receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle and will be followed through 12 months post-vaccination (through Study Day 365). Type: Interventional Start Date: May 2024 |
A Randomized Trial Evaluating a mRNA-VLP Vaccine's Immunogenicity and Safety for COVID-19
AstraZeneca
COVID-19
SARS-CoV-2 Infection
The purpose of this study is to characterize the safety and immunogenicity of AZD9838 and
AZD6563 when administered as a single dose vaccination against SARS-CoV-2 in adults.
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The purpose of this study is to characterize the safety and immunogenicity of AZD9838 and AZD6563 when administered as a single dose vaccination against SARS-CoV-2 in adults. Type: Interventional Start Date: Nov 2023 |
UNITE Study (UMN-SW) for COVID-19
University of Minnesota
Covid19
Cytokine Storm
Inflammation
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.... expand
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 |
Exercise Therapy in Cancer Patients Who Are Recovering From COVID-19
Memorial Sloan Kettering Cancer Center
Covid19
Coronavirus
Cancer
The purpose of the study is to evaluate the safety and tolerability of a 30-week aerobic
exercise therapy program in cancer patients recovering from COVID-19. The study will look at
whether the aerobic exercise therapy causes few or mild side effects in participants. Aerobic... expand
The purpose of the study is to evaluate the safety and tolerability of a 30-week aerobic exercise therapy program in cancer patients recovering from COVID-19. The study will look at whether the aerobic exercise therapy causes few or mild side effects in participants. Aerobic exercise is physical activity that uses the large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed for several minutes at a time. The aerobic exercise therapy being used in this study will be a walking program that will be adjusted so it matches participant fitness levels (how much exercise you can handle). Type: Interventional Start Date: Mar 2021 |
Hyperpolarized 129Xe MRI of Survivors of COVID-19
University of Kansas Medical Center
Covid19
The purpose of this study is to evaluate pulmonary function of patients recovering from mild,
moderate, and severe COVID-19 disease using hyperpolarized 129Xe MRI.
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The purpose of this study is to evaluate pulmonary function of patients recovering from mild, moderate, and severe COVID-19 disease using hyperpolarized 129Xe MRI. Type: Interventional Start Date: Feb 2021 |
COVID-19 In-vitro Diagnostic Test and Androgen Receptor Gene Expression
University of California, Irvine
Covid19
Androgen Receptor Gene Overexpression
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... expand
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 |
COVID-19 PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY)
University of California, San Francisco
Pregnancy
Coronavirus
COVID-19
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... expand
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 |
Study to Determine the Response to COVID-19 Vaccination and Prevalence of COVID-19 in Subjects With Chronic...
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Chronic or Recovered Hepatitis B
Chronic or Recovered Hepatitis C
Chronic or Recovered Hepatitis D
NAFLD
NASH
Background:
The COVID-19 global pandemic killed more than 6 million people worldwide. Several vaccines
have been developed against the virus that causes this disease. These vaccines are effective
at preventing severe symptoms and death from COVID-19. Some people with chronic... expand
Background: The COVID-19 global pandemic killed more than 6 million people worldwide. Several vaccines have been developed against the virus that causes this disease. These vaccines are effective at preventing severe symptoms and death from COVID-19. Some people with chronic liver disease, especially those with an advanced condition called cirrhosis, do not respond to many vaccines as well as healthy people do. The goal of this natural history study is to find out how well people with chronic liver disease respond to the COVID-19 vaccines. Objective: To learn how chronic liver disease affects the body s immune response to vaccination against COVID-19. Eligibility: People aged 18 years or older with chronic liver disease. They must also be enrolled in protocol 91-DK-0214 or 18-DK-0091. Design: Participants will have 3 visits, each spaced 6 months apart. Each visit will last 2 hours. Participants will have their vital signs recorded. These include age, sex, race, height, and weight. They will give their medical history. At each visit, participants will have blood drawn through a needle inserted into a vein in the arm. The sample drawn at each visit will be from 1 to 8 tablespoons. At each visit, participants will fill out a questionnaire. They will answer questions about whether they have been vaccinated against COVID-19; whether they have had COVID-19; and whether they have been exposed to someone who had COVID-19. The questionnaire will take 10 to 15 minutes. Researchers will also look at results of past blood tests from other research studies. Type: Observational Start Date: Mar 2023 |
A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When...
GlaxoSmithKline
Respiratory Syncytial Virus Infections
This study will assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA
investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid
(mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in... expand
This study will assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and above. Type: Interventional Start Date: Apr 2024 |
RECOVER-AUTONOMIC Platform Protocol
Kanecia Obie Zimmerman
Long COVID
Long Covid19
Long Covid-19
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,... 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, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. Type: Interventional Start Date: Mar 2024 |
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate...
BioNTech SE
Influenza
COVID-19
The purpose of this study is to understand the safety and effects of a combined influenza and
COVID-19 vaccine. This combined vaccine is compared to separate vaccines for the protection
against influenza and SARS-CoV-2. Influenza and COVID-19 are diseases that can spread easily... expand
The purpose of this study is to understand the safety and effects of a combined influenza and COVID-19 vaccine. This combined vaccine is compared to separate vaccines for the protection against influenza and SARS-CoV-2. Influenza and COVID-19 are diseases that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. Giving both influenza and COVID-19 vaccines together against influenza and SARS-CoV-2 could provide great benefits to both patients and caregivers in terms of simple and easy care. Around 9000 participants will be assigned into 1 of 4 vaccination groups (Group A, B, C or D) by chance. Cohort 1: Around 4500 participants will be assigned by chance to one of the following: - Group A:Influenza and COVID-19 combination A vaccine, given at the same time in the right arm and placebo (an injection consisting of just salt water and no medicines in it) in the left arm. - Group B: COVID-19 vaccine, given at the same time to the right arm and licensed influenza vaccine in the left arm. Cohort 2: Around 4500 participants will be assigned by chance to one of the following: - Group C: Influenza and COVID-19 combination B vaccine, given at the same time in the right arm and placebo in the left arm. - Group D: COVID-19 vaccine, given at the same time in the right arm and licenced influenza vaccine in the left arm. All participants will receive 2 injections as per their assigned study group at Visit 1. The participants will be followed for about 6 months. During this time, the study will compare participant experiences when they receive a combined vaccination to when they receive separate vaccinations. This will help understand if the study medicine is safe. Type: Interventional Start Date: Dec 2023 |
Ensitrelvir for Viral Persistence and Inflammation in People Experiencing Long COVID
Timothy Henrich
Long COVID
Post Acute Sequelae of COVID-19
Post-Acute COVID-19
Persistent viral infection with viral reservoirs and detection of circulating spike protein
after the initial acute illness is one potential pathogenic mechanism for Long COVID. This
mechanism may be susceptible to antiviral therapy that blocks viral replication, which has... expand
Persistent viral infection with viral reservoirs and detection of circulating spike protein after the initial acute illness is one potential pathogenic mechanism for Long COVID. This mechanism may be susceptible to antiviral therapy that blocks viral replication, which has the potential to alleviate long COVID symptoms. This trial will study the safety and efficacy of Ensitrelvir (S-217622), an antiviral, to treat individuals with Long COVID in an adult population. Type: Interventional Start Date: Apr 2024 |
PROmotion of COVID-19 BOOSTer VA(X)Ccination in the Emergency Department - PROBOOSTVAXED
University of California, San Francisco
COVID-19
The goal of this cluster randomized clinical trial is to test the efficacy of messaging
interventions to increase booster vaccine uptake in adults in the emergency department(ED).
The main question[s] and goals of this study are:
- does the intervention of vaccine messaging... expand
The goal of this cluster randomized clinical trial is to test the efficacy of messaging interventions to increase booster vaccine uptake in adults in the emergency department(ED). The main question[s] and goals of this study are: - does the intervention of vaccine messaging increase booster vaccine uptake at 30 days post ED visit? - does the intervention of asking about vaccine acceptance increase booster vaccine uptake at 30 days post ED visit? - considering recent national changes to funding and availability of updated vaccines, the investigators will examine the effects of these changes on vaccine acceptance and uptake in ED populations. Specifically, they will stratify EDs and ED patients according to the ED availability of vaccines, and they will also examine whether costs and availability of vaccines are a deterrent to patient acceptance and uptake of vaccines Type: Interventional Start Date: Jan 2024 |
Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel
Abbott Rapid Dx
COVID-19
Influenza A
Influenza B
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... expand
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 |
Building Engagement Using Financial Incentives Trial - Colorectal Cancer Screening
Tulane University
Health Behavior
Colorectal Cancer
Influenza
COVID-19
Vaccine Hesitancy
The goal of this pilot clinical trial is to determine feasibility and explore whether
financial incentives paid to primary care patients for completing colorectal cancer screening
increase completion of colorectal cancer screening. The main questions it aims to answer are:... expand
The goal of this pilot clinical trial is to determine feasibility and explore whether financial incentives paid to primary care patients for completing colorectal cancer screening increase completion of colorectal cancer screening. The main questions it aims to answer are: - Do patient financial incentives for completing colorectal cancer screening increase screening completion? - Does a patient financial incentive for colorectal cancer screening offered alongside patient financial incentives for COVID-19 and flu shots increase completion of those shots? Participants who are due for colorectal cancer screening will receive telephone outreach from primary care staff who will offer a stool-based colorectal cancer screening. Participants will be randomly assigned to either Group 1 or Group 2. Group 1 participants will be offered financial incentives for completing COVID-19 and flu shots within 2 months of enrollment. Group 2 participants will be offered financial incentives for completing a COVID-19 shot, a flu shot, and colorectal cancer screening within 2 months of enrollment. Researchers will compare to see if completion of a COVID-19 shot, a flu shot, and colorectal cancer screening is different between the two groups. Type: Interventional Start Date: Nov 2023 |
Pilot Randomized Study of RD-X19 Tx Device in Subjects With PCC (Long Covid) in the Outpatient Setting
EmitBio Inc.
Post COVID-19 Condition (PCC)
Duration of Treatment: 7 days, 2 times per day.
Following Randomization on Week 1 Day 1, Subjects will continue to have televisits and rate
symptoms and upright activity weekly during a 5 week follow up. Subjects will be followed via
in clinic visits at week 2/day 8 (+3/-0... expand
Duration of Treatment: 7 days, 2 times per day. Following Randomization on Week 1 Day 1, Subjects will continue to have televisits and rate symptoms and upright activity weekly during a 5 week follow up. Subjects will be followed via in clinic visits at week 2/day 8 (+3/-0 days) and Week 6 / day 36, (+3/-3days). Subjects will receive a weekly televisit during Week 3 / day 15 (+3/-3), Week 4 / day 22 (+3/-3), and Week 5 / day 29 (+3/-3). Type: Interventional Start Date: Oct 2023 |
Getting INFORMED and Living Well Among Asian Americans in California
University of California, San Francisco
COVID-19
Well-Being, Psychological
The project is to facilitate pandemic recovery by promoting emotional wellness among Asian
Californians. The intervention includes a 6-week program in which participants may choose to
receive text only or text + Lay Health Worker outreach targeting 600 self-identified Asian... expand
The project is to facilitate pandemic recovery by promoting emotional wellness among Asian Californians. The intervention includes a 6-week program in which participants may choose to receive text only or text + Lay Health Worker outreach targeting 600 self-identified Asian Americans residing in California who speak/read English, Chinese, Korean, Hmong, or Vietnamese. Type: Interventional Start Date: Mar 2024 |
RADx-UP CDCC Rapid Research Pilot Program "Culturally-relevant Community Connections (C3) to Increase...
Duke University
COVID-19
The purpose of this study is to identify barriers and facilitators to COVID testing among
members of the Black/African American community. The expected outcome of this project is to
increase COVID testing among Black/African American community. The secondary aim is to
examine... expand
The purpose of this study is to identify barriers and facilitators to COVID testing among members of the Black/African American community. The expected outcome of this project is to increase COVID testing among Black/African American community. The secondary aim is to examine the use of culturally relevant edutainment video messaging combined with trusted opinion leaders in the community as a strategy to increase COVID testing. Type: Observational Start Date: Aug 2023 |
A Study to Learn About How Loss of Liver Function Affects the Blood Levels of the Study Medicine Called...
Pfizer
COVID-19
The purpose of the study is to learn about the safety of PF-07817883 and how PF-07817883 is
processed in the body of adult participants. These participants will have different degrees
of loss of liver function. Participants with mild, moderate, severe or no loss of liver
function... expand
The purpose of the study is to learn about the safety of PF-07817883 and how PF-07817883 is processed in the body of adult participants. These participants will have different degrees of loss of liver function. Participants with mild, moderate, severe or no loss of liver function will be enrolled in 4 groups. This study is seeking participants who: - are male or female of 18- 75 years of age - either have different amounts of damage to liver function or for one of the groups, no damage - willing to follow the requirements of the study including stay at clinic for 6 nights and 7 days About, 6-8 participants will be selected in groups 1, 2 and 3. In group 4, around 4 to 8 participants will be selected. If participants consent to participate in the study, it may take up to 4 weeks to complete all the tests to confirm if they are eligible to participate in the study. If they seem to be eligible for the study, participants will be admitted to a clinic research unit (CRU) atleast 12 hours before dosing. On Day 1, participants will receive a single dose of study medicine (Day 1). A series of blood samples will be collected before and after dosing. Participants will be discharged from the CRU on Day 6. A follow-up phone call (on CRU visit, if needed), will occur 28-35 days after dosing. The whole study will last for a minimum of 5 weeks and a maximum of 10 weeks. Type: Interventional Start Date: Jun 2023 |
COVID Booster in Pregnancy and Lactation
Thomas Jefferson University
COVID-19
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.
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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 |
Vagal Nerve Stimulation for Post COVID Fatigue
Mayo Clinic
Post COVID Syndrome
Fatigue
Headache
The purpose of this study is to evaluate the impact of vagal nerve stimulation on patients
with post COVID syndrome who have fatigue and headache.
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The purpose of this study is to evaluate the impact of vagal nerve stimulation on patients with post COVID syndrome who have fatigue and headache. Type: Interventional Start Date: Dec 2022 |
A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age
ModernaTX, Inc.
Respiratory Syncytial Virus
The main purposes of Part A of this study are to evaluate the safety, tolerability, and
immunogenicity of mRNA-1345 coadministered with a seasonal influenza vaccine (Afluria®
Quadrivalent); to evaluate the impact of coadministered influenza vaccine on the immune
response to... expand
The main purposes of Part A of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with a seasonal influenza vaccine (Afluria® Quadrivalent); to evaluate the impact of coadministered influenza vaccine on the immune response to RSV-A; and to evaluate the impact of coadministered RSV vaccine on the immune response to influenza. The main purposes of Part B of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with mRNA-1273.214; to evaluate the effect of coadministered mRNA-1273.214 on the immune response to RSV-A; and to evaluate the effect of coadministered RSV vaccine on the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The main purposes of Part C (single arm, open-label) of this study are to evaluate the safety and tolerability of a booster dose (BD) of mRNA-1345 administered at 1 Year following a primary dose; to evaluate the immune response to RSV-A of a BD of mRNA 1345 administered at 1 Year following a primary dose; and to evaluate the immune response to RSV-B of a BD of mRNA-1345 administered at 1 Year following a primary dose. Type: Interventional Start Date: Apr 2022 |
COVID-19 & Psychiatry: A Retrospective Chart Review
Northwestern University
COVID-19
A retrospective chart review study to determine the effects of psychotropic medications and
prior psychiatric diagnoses on COVID-19 patients' disease progression, and severity.
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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 |
A Live Recombinant Newcastle Disease Virus-vectored COVID-19 Vaccine Phase 1 Study.
Sean Liu
SARS-CoV-2
This study will be a phase-1, open-label, placebo-controlled, evaluation of two-dosages of a
live, recombinant Newcastle disease virus expressing the spike protein of SARS-CoV-2
(NDV-HXP-S), an investigational product for IN, IM, or a combined IN+IM vaccination in
healthy... expand
This study will be a phase-1, open-label, placebo-controlled, evaluation of two-dosages of a live, recombinant Newcastle disease virus expressing the spike protein of SARS-CoV-2 (NDV-HXP-S), an investigational product for IN, IM, or a combined IN+IM vaccination in healthy adults previously immunized against COVID-19. The IN and IM live virus vaccinations will be identical in composition and only differ in route of administration. Type: Interventional Start Date: Feb 2022 |
Safety and Acceptability of Q GRFT Nasal Spray for COVID-19 Prophylaxis
Sharon Hillier
COVID-19
Pharmacokinetics
Safety
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... expand
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 |
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