Newswires
Title Not in Corporate Clinical Trial Registry (CCTR): Coronavirus – COVID-19
2023 JUN 08 (NewsRx) -- By a
As a matter of record, on
Tracking Information
| Trial Identifier | NCT05876377 |
| First Submitted Date | |
| First Posted Date | |
| Results First Submitted Date | Not Provided |
| Results First Posted Date | Not Provided |
| Last Update Submitted Date | |
| Last Update Posted Date | |
| Primary Completion Date | |
| Start Date | |
| Current Primary Outcome Measures | •Number of patients with Post-COVID condition (PCC) defined as a composite of 3 definitions [ Time Frame: 29-120 days after COVID-19 diagnosis ] -- A diagnosis of PCC using the ICD-10-CM code OR new onset of specific conditions (Cardiovascular, Hemolytic and Vascular, Pulmonary, Renal, gastrointestinal, Neurologic, Endocrine or Mental health) OR new onset of any commonly experienced diagnosis or symptom. |
| •Number of patients with an mRNA bivalent vaccination [ Time Frame: Date of vaccine authorization through a minimum of 8 months ] -- Any record of mRNA bivalent vaccination as recorded in the state immunization registry. | |
| Current Secondary Outcome Measures | •Number of patients with PCC defined using the ICD-10-CM code [ Time Frame: 29-120 days after COVID-19 diagnosis ] |
| •Number of patients with PCC defined with a new specific condition [ Time Frame: 29-120 days after COVID-19 diagnosis ] -- A new onset of any of the following specific conditions (Cardiovascular, Hemolytic and Vascular, Pulmonary, Renal, gastrointestinal, Neurologic, Endocrine or Mental health) | |
| •Number of patients with a new PCC defined with commonly experienced diagnoses or symptoms [ Time Frame: 29-120 days after COVID-19 diagnosis ] | |
| •Number of patients with PCC defined with a new diagnosis for a cardiovascular condition [ Time Frame: 29-120 days after COVID-19 diagnosis ] | |
| •Number of patients with PCC defined with a new diagnosis for a hemolytic/vascular condition [ Time Frame: 29-120 days after COVID-19 diagnosis ] | |
| •Number of patients with PCC defined with a diagnosis for a new pulmonary condition [ Time Frame: 29-120 days after COVID-19 diagnosis ] | |
| •Number of patients with PCC defined with a diagnosis for a new musculoskeletal condition [ Time Frame: 29-120 days after COVID-19 diagnosis ] | |
| •Number of patients with PCC defined with a new diagnosis for a renal condition [ Time Frame: 29-120 days after COVID-19 diagnosis ] | |
| •Number of patients with PCC defined with a diagnosis for a new gastrointestinal condition [ Time Frame: 29-120 days after COVID-19 diagnosis ] | |
| •Number of patients with PCC defined with a diagnosis for a new neurologic condition [ Time Frame: 29-120 days after COVID-19 diagnosis ] | |
| •Number of patients with PCC defined with a diagnosis for a new endocrine condition [ Time Frame: 29-120 days after COVID-19 diagnosis ] | |
| •Number of patients with PCC defined with a diagnosis for a new mental health condition [ Time Frame: 29-120 days after COVID-19 diagnosis ] | |
| Other Outcome Measures | Not Provided |
| Change History | Complete list of historical revisions of study NCT05876377 |
Descriptive Information
| Brief Title | Effectiveness and Use of COVID-19 Vaccines Using Information From the California State Vaccine Registry |
| Official Title | Title Not in Corporate Clinical Trial Registry (CCTR) |
| Brief Summary | This study aims to use vaccination information from the California Immunization Registry linked with HealthVerity insurance claims for patients residing in |
| Detailed Description | Not Provided |
| Study Type | Observational |
| Study Phase | Not Provided |
| Study Design | Observational Model: Cohort |
| Time Perspective: Retrospective | |
| Condition | SARS-CoV-2 |
| COVID-19 | |
| Post-Acute COVID-19 Syndrome | |
| Intervention | •Biological: Pfizer-BioNTech COVID-19 bivalent mRNA vaccine |
| Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older. | |
| Other Names: | |
| ⚬Pfizer-BioNTech COVID-19 Vaccine, Bivalent | |
| Study Arms | •Boosted with Pfizer-BioNTech COVID-19 bivalent mRNA vaccine |
| Patient identified in the vaccine registry having a single dose Pfizer-BioNTech COVID-19 bivalent mRNA vaccine after completion of the primary series | |
| Interventions: | |
| ⚬Biological: Pfizer-BioNTech COVID-19 bivalent mRNA vaccine |
Recruitment Information
| Recruitment Status | Not yet recruiting |
| Estimated Enrollment | 18000000 |
| Estimated Completion Date | |
| Primary Completion Date | |
| Eligibility | Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: Include patients whose claims records and vaccine registry data are both available in the HealthVerity databases Include patients who are eligible to receive the bivalent booster during the study period ≥2 monovalent doses have been received ≥2 months have elapsed since the most recent prior monovalent dose. Exclusion Criteria: Patients meeting any of the following criteria will not be included in the study: Exclude patients with a PCC episode prior to being eligible for the bivalent mRNA COVID-19 vaccine booster Receipt of the bivalent mRNA COVID-19 vaccine booster prior to authorization Exclude patients ≥12 years old who received a bivalent mRNA COVID-19 vaccine booster prior to |
| Sex/Gender | Sexes Eligible for Study: All |
| Ages | 6 months to 99 years |
| No | |
| Contacts | Primary contact: Pfizer CT.gov Call Center, 1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com |
| Listed Location Countries | Not Provided |
| Removed Location Countries |
Administrative Information
| NCT Number | NCT05876377 |
| Other Study ID Numbers | C4591059 |
| Has Data Monitoring Committee | Not Provided |
| Studies a |
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| Studies a |
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| Plan to Share Data | No |
| Plan to Share Data (IPD) Description | |
| Collaborators | Not Provided |
| Investigators | Study Director: Pfizer CT.gov Call Center, |
| Information Provided By | |
| Verification Date |
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