Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-26 @ 2:38 PM
NCT ID:
NCT05911906
Description:
The PenCTU data team will have access to the trial dataset, including identifiable participant data. Other members of the CTU and the wider study team will have restricted access to pseudo-anonymised study data. Access to the dataset will be granted to the Sponsor and host institution on request, to permit study-related monitoring, audits and inspections. Access will be overseen by the CTU data manager and trial manager. Access to the final dataset will be provided to the trial statisticians for analysis. After the trial has been reported, the anonymised individual participant data that underlie the results will be available on request from the CI and Sponsor, along with supplementary files as required (e.g., data dictionaries, blank data collection forms, analysis code, etc). Data will be shared with (or access to the data will be provided to) requestors whose proposed use of the data has been approved by the CI and Sponsor, under an appropriate data-sharing agreement.
Study:
NCT05911906
Study Brief:
An Open-label, Clinical Feasibility Study of the Efficacy of Remdesivir for Long-COVID.