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0 0.5 1 1.5 2+ Symptomatic case 24% Improvement Relative Risk Symptomatic case, MH 29% Symptomatic case, PCR+ 51% Symptomatic case, pooled 26% c19hcq.org Naggie et al. NCT04334148 HERO-HCQ HCQ RCT PrEP Is pre-exposure prophylaxis with HCQ beneficial for COVID-19? Double-blind RCT 1,359 patients in the USA (April - November 2020) Fewer symptomatic cases with HCQ (not stat. sig., p=0.18) Naggie et al., Int. J. Infectious Diseases, doi:10.1016/j.ijid.2023.01.019 Favors HCQ Favors control
Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: A randomized, multicenter, placebo-controlled trial (HERO-HCQ)
Naggie et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2023.01.019 (date from earlier preprint), HERO-HCQ, NCT04334148 (history)
Naggie et al., Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: A randomized, multicenter,.., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2023.01.019 (date from earlier preprint), HERO-HCQ, NCT04334148
Aug 2021   Source   PDF  
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HCQ prophylaxis RCT reporting statistically significant lower cases when pooling results with the COVID PREP RCT, OR 0.74 [0.55-1.0] p = 0.046. There were no significant safety issues.
The trials were both terminated early resulting in a loss of power, however the combination shows statistically significant efficacy of HCQ. Note that this result has been censored in the journal version, see [medrxiv.org]. The journal paper still shows the COVID PREP paper in the reference list, but the analysis and discussion has been deleted.
The journal version falsely states: "The prophylactic use of HCQ by HCW was safe but not effective", whereas the paper actually estimates OR 0.75, which becomes statistically significant OR 0.74 when pooled with COVID PREP.
The preprint contains a different version: "...but did not produce a clinically useful treatment". It's unclear why ~25% fewer cases would not be useful.
They also state "This is one of several negative studies", however the result is positive, just not reaching statistical significance before pooling with COVID PREP.
risk of symptomatic case, 23.5% lower, RR 0.76, p = 0.18, treatment 41 of 683 (6.0%), control 53 of 676 (7.8%), NNT 54, odds ratio converted to relative risk, logistic regression.
risk of symptomatic case, 29.3% lower, RR 0.71, p = 0.18, treatment 41 of 683 (6.0%), control 53 of 676 (7.8%), NNT 54, odds ratio converted to relative risk, Mantel-Haenszel.
risk of symptomatic case, 50.5% lower, RR 0.49, p = 0.34, treatment 3 of 683 (0.4%), control 6 of 676 (0.9%), NNT 223, PCR confirmed.
risk of symptomatic case, 26.0% lower, OR 0.74, p = 0.046, pooled results with COVID-PREP, RR approximated with OR.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Naggie et al., 25 Aug 2021, Double Blind Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, mean age 43.6, 23 authors, study period April 2020 - November 2020, trial NCT04334148 (history) (HERO-HCQ).
Contact: susanna.naggie@duke.edu.
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Abstract: Journal Pre-proof Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: A randomized, multicenter, placebo-controlled trial (HERO-HCQ) Susanna Naggie , Aaron Milstone , Mario Castro , Sean P. Collins , Seetha Lakshmi , Deverick J. Anderson , Lizbeth Cahuayme-Zuniga , Kisha Batey Turner , Lauren W. Cohen , Judith Currier , Elizabeth Fraulo , Anne Friedland , Jyotsna Garg , Anoop George , Hillary Mulder , Rachel E. Olson , Emily C. O’Brien , Russell L. Rothman , Elizabeth Shenkman , Jack Shostak , Christopher W. Woods , Kevin J. Anstrom , Adrian F. Hernandez , on behalf of the HERO Research Program PII: DOI: Reference: S1201-9712(23)00019-X https://doi.org/10.1016/j.ijid.2023.01.019 IJID 6591 To appear in: International Journal of Infectious Diseases Received date: Revised date: Accepted date: 27 July 2022 6 January 2023 12 January 2023 Please cite this article as: Susanna Naggie , Aaron Milstone , Mario Castro , Sean P. Collins , Seetha Lakshmi , Deverick J. Anderson , Lizbeth Cahuayme-Zuniga , Kisha Batey Turner , Lauren W. Cohen , Judith Currier , Elizabeth Fraulo , Anne Friedland , Jyotsna Garg , Anoop George , Hillary Mulder , Rachel E. Olson , Emily C. O’Brien , Russell L. Rothman , Elizabeth Shenkman , Jack Shostak , Christopher W. Woods , Kevin J. Anstrom , Adrian F. Hernandez , on behalf of the HERO Research Program, Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: A randomized, multicenter, placebo-controlled trial (HERO-HCQ), International Journal of Infectious Diseases (2023), doi: https://doi.org/10.1016/j.ijid.2023.01.019 This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2023 Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/) Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: a randomized, multicenter, placebo-controlled trial (HERO-HCQ) Susanna Naggie, MDa, Aaron Milstone, MD, MHSb, Mario Castro, MD, MPHc, Sean P. Collins, MD, PhDd, Seetha Lakshmi, MDe, Deverick J. Anderson, MDf, Lizbeth Cahuayme-Zuniga, MDg, Kisha Batey Turner, BSd, Lauren W. Cohen, MAa, Judith Currier, MDh, Elizabeth Fraulo, RN, BSNa, Anne Friedland, MDa, Jyotsna Garg, MSa, Anoop George, RTT, MPAi, Hillary Mulder, PhDa, Rachel E. Olson, RN, MS, MBAa, Emily C. O’Brien, PhDa, Russell L. Rothman, MD, MPPd, Elizabeth Shenkman, PhDj, Jack Shostak, MBAa, Christopher W. Woods, MDa, Kevin J. Anstrom, PhDk, Adrian F. Hernandez, MD, MHSa, on behalf of the HERO Research Program a Duke Clinical Research Institute, Duke University, Durham, North Carolina USA b Williamson Medical Center, Franklin, Tennessee USA c University of Kansas Medical Center, Kansas City, Kansas USA d Vanderbilt University Medical Center, Nashville, Tennessee USA e University of South Florida, Tampa, Florida..
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