Controlled, double-blind, randomized trial to assess the efficacy and safety of hydroxychloroquine chemoprophylaxis in SARS CoV2 infection in healthcare personnel in the hospital setting: A structured summary of a study protocol for a randomised controlled trial

Assessed by RV006 · Research Assistant/Biostatistician

Assessed on 4 Nov 2025

OverallReviewer's overall integrity assessment, derived from all research questions Some concerns

DOI 10.1186/s13063-020-04400-4 (opens in new tab)

Resource ripekg:research-integrity-assessment/RIPEA7A26A29DA8B9E483

5 Research Questions · 2 Evidence Items

Q1.1 — Does the study have an associated retraction?

Automated Assessment:Assessment produced by the automated systemNo

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsNo

Rationale: No rationale provided

Q1.2 — Does the study have an associated expression of concern or other relevant post-publication notice?

Automated Assessment:Assessment produced by the automated systemNo

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsNo

Rationale: No rationale provided

Q1.3 — Do other studies by the research team highlight causes for concern?

Automated Assessment:Assessment produced by the automated systemNo

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsNo

Rationale: No rationale provided

Q2.2 — Are there concerns relating to the timing or absence of study registration?

Automated Assessment:Assessment produced by the automated systemUnclear

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsUnclear

Rationale: The registration date of this protocol is 5/15/2020 via https://www.clinicaltrialsregister.eu/ctr-search/search?query=2020-001704-42. This study is ongoing and not start recruitment "Currently, recruitment has not yet started, with the start scheduled for the second week of May 2020.", and it has not updated. I was not able to find this trial on EU Clinical website https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en.

Supporting Evidence (2)

Clinical Trial RegistrationSource: Clinical trial registry (e.g. ClinicalTrials.gov, ISRCTN)

Registration ID: 2020-001704-42

Registry: EU CTR

Registry Link: https://trialsearch.who.int/Trial2.aspx?TrialID=2020-001704-42 (opens in new tab)

Prospective:Whether the trial was registered before participant recruitment began No

Assessment Rationale:How INSPECT-AI determined the prospective registration status by comparing dates LLM-extracted recruitment start date (normalized_date) is missing or empty.

Study Design EvidenceDates and timelines extracted by INSPECT-AI from the publication text

Recruitment Start: N/A

Recruitment Start Rationale:INSPECT-AI's reasoning for how it identified the recruitment start date Currently, recruitment has not yet started, with the start scheduled for the second week of May 2020, but no specific date is mentioned.

Recruitment End: N/A

Recruitment End Rationale:INSPECT-AI's reasoning for how it identified the recruitment end date No explicit end-of-recruitment date after full search.

Study End: N/A

Study End Rationale:INSPECT-AI's reasoning for how it identified the study end date No explicit study end date found.

Overall — What is the overall integrity assessment of the study?

Automated Assessment:Assessment produced by the automated systemN/A

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsSome concerns

Rationale: No rationale provided