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0 0.5 1 1.5 2+ Symp. case -60% Improvement Relative Risk Symp. case (b) -110% Symp. case (c) 16% Case -92% Case (b) -137% Case (c) -21% HCQ  Syed et al.  Prophylaxis  RCT Is pre-exposure prophylaxis with HCQ beneficial for COVID-19? RCT 101 patients in Pakistan (May - September 2020) More symptomatic cases (p=0.41) and cases (p=0.12), not sig. Syed et al., Cureus, May 2021 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 preprint), NCT04359537
May 2021  
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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, study period 1 May, 2020 - 25 September, 2020, trial NCT04359537 (history).
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Pre-exposure Prophylaxis With Various Doses of Hydroxychloroquine Among Healthcare Personnel With High-Risk Exposure to COVID-19: A Randomized Controlled Trial
Fibhaa Syed, Muhammad Hassan, Mohammad Ali Arif, Sadia Batool, Rauf Niazi, Ume E Laila, Sadia Ashraf, Junaid Arshad
Cureus, doi:10.7759/cureus.20572
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.
Additional Information Disclosures Human subjects: Consent was obtained or waived by all participants in this study. Shaheed Zulfiqar Ali Bhutto Medical University Ethical Review Committee issued approval F.1-1/2015/ERB/SZABMU/549. Unconditional approval of the project. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.
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