Viral SARS-CoV-2 rebounds in commercial pharmacy-based SARS-CoV-2 PCR testing

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105624
• EU PAS number:
  EUPAS103517
• Study ID:
  105624
• Official title and acronym:
  Viral SARS-CoV-2 rebounds in commercial pharmacy-based SARS-CoV-2 PCR testing
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a non-interventional, retrospective cohort study using secondary data sources containing structured data from the US. This study will include adults (≥18 years of age) and pediatric participants (<18 years of age) with a positive SARS-CoV-2 test (e.g. positive polymerase chain reaction (PCR) of direct SARS-CoV-2 viral testing). This study will be conducted using SARS-CoV-2 diagnostic testing data from the Helix Respiratory Registry with linkage to the retrospective Komodo Healthcare claims data during the period of June 01, 2020, to February 28, 2023. Viral SARS-CoV-2 rebound will be examined after stratification of variables such as SARS-CoV-2 therapeutic treatment, viral load patterns, high-risk status for progression to severe SARS-CoV-2, age (<50 years of age versus 50+ years of age), and by timing around rebounds in relation to initial test positivity to treatment for SARS-CoV-2.
• Study status:
  Ongoing

Research institution and networks

Institutions

Pfizer

Helix OpCo, LLC

Study timelines

Date when funding contract was signed

Planned: 17/11/2022

Actual: 17/11/2022

Study start date

Planned: 22/02/2023

Actual: 23/02/2023

Data analysis start date

Planned: 22/02/2023

Actual: 23/02/2023

Date of final study report

Planned: 15/02/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

C4671048 NI APPROVED PROTOCOL_FINAL_V1.0_08FEB2023_redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable