tetano
Editor, Senior Moderator
Cureus
. 2021 Dec 21;13(12):e20572.
doi: 10.7759/cureus.20572. eCollection 2021 Dec.
Pre-exposure Prophylaxis With Various Doses of Hydroxychloroquine Among Healthcare Personnel With High-Risk Exposure to COVID-19: A Randomized Controlled Trial
Fibhaa Syed[SUP] 1 [/SUP], Muhammad Hassan[SUP] 2 [/SUP], Mohammad Ali Arif[SUP] 1 [/SUP], Sadia Batool[SUP] 1 [/SUP], Rauf Niazi[SUP] 1 [/SUP], Ume E Laila[SUP] 1 [/SUP], Sadia Ashraf[SUP] 1 [/SUP], Junaid Arshad[SUP] 3 [/SUP]
Affiliations
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.
Keywords: covid-19; healthcare personnel; hydroxychloroquine.; pre-exposure prophylaxis; sars-cov-2.
. 2021 Dec 21;13(12):e20572.
doi: 10.7759/cureus.20572. eCollection 2021 Dec.
Pre-exposure Prophylaxis With Various Doses of Hydroxychloroquine Among Healthcare Personnel With High-Risk Exposure to COVID-19: A Randomized Controlled Trial
Fibhaa Syed[SUP] 1 [/SUP], Muhammad Hassan[SUP] 2 [/SUP], Mohammad Ali Arif[SUP] 1 [/SUP], Sadia Batool[SUP] 1 [/SUP], Rauf Niazi[SUP] 1 [/SUP], Ume E Laila[SUP] 1 [/SUP], Sadia Ashraf[SUP] 1 [/SUP], Junaid Arshad[SUP] 3 [/SUP]
Affiliations
- PMID: 35103151
- PMCID: PMC8776514
- DOI: 10.7759/cureus.20572
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.
Keywords: covid-19; healthcare personnel; hydroxychloroquine.; pre-exposure prophylaxis; sars-cov-2.
