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Covid19 clinical trials

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NCT ID: NCT05040789 Withdrawn - COVID-19 Clinical Trials

Phase 3 Study to Evaluate the Lot Consistency of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine

Start date: November 22, 2021
Phase: Phase 3
Study type: Interventional

This Phase 3 study is intended to assess clinical lot-to-lot consistency by evaluating and comparing the immunogenicity of three consecutively manufactured lots of Coronavirus-like Particle (CoVLP).

NCT ID: NCT05040776 Withdrawn - Covid19 Clinical Trials

COVID-19 ThromboprophylaXIs Study of Novel FXIa Inhibitor Frunexian (EP-7041) in ICU Patients

Start date: October 2023
Phase: Phase 2
Study type: Interventional

This is a multicenter, open-label, single cohort study of patients with confirmed COVID-19 syndrome who based on clinical judgment require care in an intensive care unit, regardless of whether or not mechanical ventilation is in use or is anticipated. Patients should be enrolled on the first day of the ICU stay; withdrawal of prior thromboprophylaxis, if any, will follow specific protocol guidance. Enrolled patients will thereafter be administered intravenous frunexian (EP-7041) until disposition from the hospital (including post-ICU non-critical care management)

NCT ID: NCT05037019 Withdrawn - Breast Cancer Clinical Trials

SIGNAL During a COVID-19 Pandemic

Start date: May 2020
Phase: N/A
Study type: Interventional

The standard treatment for early stage, estrogen-receptor positive breast cancer is lumpectomy and sentinel lymph node biopsy followed by 16-25 treatments of adjuvant whole-breast radiation therapy plus or minus hormone therapy. However, the COVID-19 pandemic has necessitated changes in the way breast cancer is treated in order to reduce contact between individuals, reduce spread of the novel coronavirus, and lessen the impact on health care resources. As elective surgeries are being cancelled, current pandemic guidelines recommend that patients be started on hormone treatment while waiting for surgeries to be re-instated. Only after this surgery occurs will patients receive radiation treatment, dramatically extending the time between diagnosis and end of treatment. Emergency pandemic guidelines in the UK and other countries recommend 5 fractions of pre-operative radiation therapy where appropriate. Based on previous work in the SIGNAL 1.0 and SIGNAL 2.0 clinical trials, the investigators are proposing treating patients with early stage breast cancers with one single fraction of stereotactic neoadjuvant radiation during the pre-operative waiting period. This will allow patients to complete radiation therapy upfront while reducing the number of patient visits to hospital. This will also allow investigators to evaluate the ability of single-fraction targeted radiation to induce a pathologic complete response.

NCT ID: NCT05029856 Withdrawn - Covid19 Clinical Trials

Evaluation of the Safety and Immunogenicity of SII Vaccine Constructs Based on the SARS-CoV-2 (COVID-19) Variant in Adults

Start date: February 4, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a randomized, observer-blinded, Phase 1/2 study with an open-label group to evaluate the safety and immunogenicity of 3 novel SARS-CoV-2 variant vaccine constructs adjuvanted with Matrix-M1 adjuvant. Investigational products will include a monovalent SII SARS-CoV-2 B.1.351 (Beta) variant vaccine (SII B.1.351), a bivalent SII vaccine containing antigen for both the ancestral strain and B.1.351 (Beta) variant of SARS-CoV-2 (SII Bivalent), and a monovalent SII SARS-CoV-2 B.1.617.2 (Delta) variant vaccine (SII B.1.617.2).

NCT ID: NCT05029245 Withdrawn - Covid19 Clinical Trials

IntraDermal Versus Intramuscular Comirnaty® Efficacy Study

PRIDE
Start date: August 31, 2021
Phase: Phase 3
Study type: Interventional

The 8-week, Prospective, Randomized controlled of IntraDermal administration of Comirnaty® 6 microgram compare to Intramuscular Comirnaty® 30 microgram by 28 days interval Efficacy Study in 4 groups of healthy volunteer ( 1 people who complete sinovac vaccination 2 people who received 1 dosage of AstraZeneca vaccine 3 naive vaccination 4 any other vaccination not in 1-3 with anti Spike antibody less than 650 AU/ ml) . Comparison of antibody level and T cell response to SAR-CoV-2 antigen in vitro after 28 day post vaccination is primary outcome and the side effect as well as infection rate in 8 weeks is secondary outcomes.

NCT ID: NCT05026801 Withdrawn - Clinical trials for Respiratory Tract Infection Viral

Azithromycin Plus Hydroxychloroquine for COVID-19 Infection

Start date: February 8, 2021
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blinded, Phase 3, multi-center trial of the clinical and microbiologic response of patients with a respiratory tract infection (RTI) due to coronavirus treated with a combination of azithromycin and hydroxychloroquine. Approximately 200 patients with symptoms of an RTI who test positive for SARS-CoV-2 by polymerase chain reaction (PCR) will receive a combination of azithromycin 500 mg and hydroxychloroquine 600 mg or matching placebos for six consecutive days. There will be two treatment regimens into which patients are randomized so that all patients will receive some active therapy.

NCT ID: NCT05023512 Withdrawn - Covid19 Clinical Trials

Understanding Public Attitudes Towards the COVID-19 Vaccination

CEAL
Start date: October 28, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to better understand public attitudes towards coronavirus disease 2019 (COVID-19) vaccination. This understanding will inform the development of community engagement strategies to be used in future interventions and studies aimed at addressing factors that impact the disproportionate burden of COVID-19 in under-served and vulnerable communities.

NCT ID: NCT05018975 Withdrawn - Clinical trials for COVID-19 Acute Respiratory Distress Syndrome

Tazemetostat for the Treatment of Moderate to Severe COVID-19 Infection

IST
Start date: January 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of repurposing tazemetostat for the treatment of Acute Respiratory Distress Syndrome (ARDS) or Systemic Cytokine Release Syndrome (SCRS) in COVID-19 patients.

NCT ID: NCT05016934 Withdrawn - Covid19 Clinical Trials

Evaluation of Safety and Immunogenicity of a Novel Vaccine for Prevention of Covid-19 in Adults Previously Immunized

Start date: November 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Randomized controlled trial to evaluate safety, immunogenicity and efficacy of three different doses (10, 25 and 50 mcg) of a novel vaccine compared with placebo in adult volunteers previously immunized against Covid-19 with other vaccines [Corona Vac (Sinovac), ChAdOx1 (AZ 1222, Astra Zeneca) or Ad26.Co2.S (Janssen)].

NCT ID: NCT04993326 Withdrawn - Covid19 Clinical Trials

Advancing DSME/S and COVID-19 Prevention and Protection Through "emPOWERed to Change" Program

Start date: January 10, 2022
Phase: N/A
Study type: Interventional

African Americans (AA)/People of Color (POC) are disproportionately impacted by COVID-19 to an extent not observed in other racial/ethnic subgroups. People of color are uniquely affected because keeping diabetes under control - the best defense against COVID-19 - has become more difficult as the pandemic has disrupted medical care, exercise and healthy eating routines which are already well-known challenges for the African American community. Diabetes Self-Management Education and Support (DSMS/S) facilitates the knowledge, skills, and ability necessary for diabetes self-care as well as activities that assist a person in implementing and sustaining the behaviors needed to manage their condition on an ongoing basis. Now, given the implications of COVID-19 on the AA/POC diabetes community, it is imperative to enhance DSME/S with education about protection and prevention of COVID-19. To begin to solve this problem we will adapt and implement the "emPOWERed to Change" DSME/S program to provide enhanced type 2 diabetes mellitus (T2DM) education with an additional emphasis on COVID-19 protection and prevention. This study will employ Community Based Participatory Research methods and will be conducted virtually in the community setting. The proposed hypothesis, based on the Health Belief Model (HBM) and the Theory of Planned Behavior (TPB), is: African Americans (AA)/People of Color (POC) in Los Angeles County with type 2 diabetes mellitus (T2DM) randomized to participate in the "emPOWERed to Change" program (N=48) are more likely to demonstrate sustained glycemic control, increase in knowledge and skills related behaviors, and risk factors associated with T2DM and SARS-CoV-2 (COVID-19) and increased compliance with prevention, and vaccination as compared to those who are randomized to usual care (N=48) in this 12 week program. We propose a randomized control study design among 96 participants with 48 assigned to an intervention group and 48 assigned to a control group. This study will also explore the experience of the participants' appraisal of knowledge and skills acquisition for DSME/S to maintain T2DM control, reduce complications, and SARS-CoV-2 (COVID-19) prevention and protection. The ultimate goal is to design prospective larger behavioral studies (SuRe first or R21) with a multi-centered intervention with other RTRN institutions to demonstrate the applicability of this approach specifically focusing on the AA/POC community.