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0 0.5 1 1.5 2+ Symptomatic case -60% Improvement Relative Risk Symptomatic case (b) -110% Symptomatic case (c) 16% Case -92% Case (b) -137% Case (c) -21% Syed et al. NCT04359537 HCQ RCT PrEP Is pre-exposure prophylaxis with HCQ beneficial for COVID-19? RCT 101 patients in Pakistan More symptomatic cases (p=0.41) and cases (p=0.12), not stat. sig. Syed et al., Cureus, doi:10.7759/cureus.20572 Favors HCQ Favors control
Pre-exposure Prophylaxis With Various Doses of Hydroxychloroquine Among Healthcare Personnel With High-Risk Exposure to COVID-19: A Randomized Controlled Trial
Syed et al., Cureus, doi:10.7759/cureus.20572 (date from earlier preprint), NCT04359537 (history)
Syed et al., Pre-exposure Prophylaxis With Various Doses of Hydroxychloroquine Among Healthcare Personnel With High-Risk.., Cureus, doi:10.7759/cureus.20572 (date from earlier preprint), NCT04359537
May 2021   Source   PDF  
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Small PrEP RCT of low risk healthcare workers, showing no significant differences. Authors report that there was no hospitalization, ICU care, or death from COVID-19, however table 3 of the preprint shows severe events labeled as "requiring hospitalization". Symptomatology and disease severity results in tables 3 and 4 appear inconsistent. NCT04359537 (history).
risk of symptomatic case, 59.7% higher, RR 1.60, p = 0.41, treatment 10 of 48 (20.8%), control 6 of 46 (13.0%), group 1.
risk of symptomatic case, 110.5% higher, RR 2.10, p = 0.13, treatment 14 of 51 (27.5%), control 6 of 46 (13.0%), group 2.
risk of symptomatic case, 16.4% lower, RR 0.84, p = 0.77, treatment 6 of 55 (10.9%), control 6 of 46 (13.0%), NNT 47, group 3.
risk of case, 91.7% higher, RR 1.92, p = 0.12, treatment 15 of 38 (39.5%), control 7 of 34 (20.6%), group 1.
risk of case, 136.6% higher, RR 2.37, p = 0.02, treatment 19 of 39 (48.7%), control 7 of 34 (20.6%), group 2.
risk of case, 21.4% higher, RR 1.21, p = 0.77, treatment 8 of 32 (25.0%), control 7 of 34 (20.6%), group 3.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Syed et al., 17 May 2021, Randomized Controlled Trial, Pakistan, peer-reviewed, 8 authors, trial NCT04359537 (history).
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Abstract: Open Access Original Article DOI: 10.7759/cureus.20572 Pre-exposure Prophylaxis With Various Doses of Hydroxychloroquine Among Healthcare Personnel With High-Risk Exposure to COVID-19: A Randomized Controlled Trial Review began 12/04/2021 Review ended 12/16/2021 Published 12/21/2021 © Copyright 2021 Syed et al. This is an open access article distributed under the terms of the Creative Fibhaa Syed 1 , Muhammad Hassan 2 , Mohammad Ali Arif 1 , Sadia Batool 1 , Rauf Niazi 1 , Ume E. Laila 1 , Sadia Ashraf 1 , Junaid Arshad 3 Commons Attribution License CC-BY 4.0., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. 1. Internal Medicine, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad, PAK 2. Neurology, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad, PAK 3. Cardiology, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad, PAK Corresponding author: Muhammad Hassan, Abstract Objective This trial aimed to evaluate the safety and efficacy of pre-exposure prophylaxis (PrEP) with various hydroxychloroquine (HCQ) doses against a placebo among healthcare personnel (HCP) with high-risk exposure to coronavirus disease 2019 (COVID 19). Methods A phase II, randomized, placebo-controlled trial was conducted including 200 subjects with no active or past severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (antibody testing and reverse transcription-polymerase chain reaction (RT-PCR) were taken at the time of enrollment). Subjects of experimental groups one to three received HCQ in various doses and the control group received a placebo. The study outcomes in terms of safety and efficacy were monitored. Participants exhibiting COVID-19 symptoms were tested for SARS-CoV-2 during the study and by the end of week 12 with RT-PCR or serology testing (COVID-19 IgM/IgG antibody testing). Results Out of the total participants, 146 reported exposure to a confirmed COVID-19 case in the first month, and 192 were exposed by week 12 of the study. Moreover, the precautionary use of personal protective equipment (PPE) significantly varied; initially more than 80% of the exposed HCPs were not ensuring PPE being used by the patients treated by them, which gradually developed over time. Mild treatment-related side effects were observed among the interventional and placebo arm patients. There was no significant clinical benefit of PrEP with HCQ as compared to placebo (p>0.05). Conclusion It is concluded that the PrEP HCQ does not significantly prevent COVID-19 among high-risk HCPs. Categories: Preventive Medicine, Infectious Disease Keywords: hydroxychloroquine., healthcare personnel, covid-19, pre-exposure prophylaxis, sars-cov-2
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