Trials Annotator

Trial NCT04329923

View at ClinicalTrials.gov

Org. Study IDs: 842838

Last trial update was posted on 2020-12-10

MeSH Interventions

Hydroxychloroquine

MeSH Conditions

COVID-19

Other Conditions

Stopping Reasons

Cohort 1: slow accrual Cohort 2: Other studies showed no benefit Cohort 3: Study met pre-specificied futility analysis at planned second interim analysis

Limitations And Caveats

Sub-study 1 was terminated early after the first interim analysis due to slow accrual Sub-study 2 was terminated early after the first 7 patients based on the recommendation of UPenn research oversight committees Sub-study 3 was terminated early due to meeting futility criteria on a pre-specified second interim analysis

Result Publications

Abella BS, Jolkovsky EL, Biney BT, Uspal JE, Hyman MC, Frank I, Hensley SE, Gill S, Vogl DT, Maillard I, Babushok DV, Huang AC, Nasta SD, Walsh JC, Wiletyo EP, Gimotty PA, Milone MC, Amaravadi RK; Prevention and Treatment of COVID-19 With Hydroxychloroquine (PATCH) Investigators. Efficacy and Safety of Hydroxychloroquine vs Placebo for Pre-exposure SARS-CoV-2 Prophylaxis Among Health Care Workers: A Randomized Clinical Trial. JAMA Intern Med. 2021 Feb 1;181(2):195-202. doi: 10.1001/jamainternmed.2020.6319. [PMID: 33001138] [DOI: 10.1001/jamainternmed.2020.6319]

Annotations

Category Annotations

No annotators decided on categories yet

Intervention Annotations

#	Outdated	Intervention				Condition
#	Outdated	Name		Route	DrugBank ID	Condition