The prophylactic effect of hydroxychloroquine on the severity of COVID-19 infection in an asymptomatic population: A randomized clinical trial
Termeh Tarjoman, Mahnaz Valizadeh, Parisa Shojaei, Behnam Farhoo, Mehrangi Zange, Masood Naj, Seyed Hamid Jamaldi, Masoumeh Mesgar, Za Hanifezadeh, Fae Abdollahi, Hamidreza Massumi Naini, Mohsen Alijani, Hasti Ziaee, Dr Arezoo Chouhdari
doi:10.22037/sdh.v10i1.43032
Background: Laboratory and observational data suggest that hydroxychloroquine (HCQ) has biological activity against SARS-CoV-2, potentially permitting its use for disease prevention. This study aimed to evaluate the hydroxychloroquine effect as prophylaxis for SARS-CoV-2 infection. Methods: This double-blind randomized controlled trial was performed on 1000 people between 18-65 who were not suspected of having COVID-19 symptoms at the time of enrollment and had no positive COVID-19 virus test. Hydroxychloroquine or placebo tablets (800 mg/d for the first day followed by 200 mg/d for 6 weeks) were prescribed randomly for participants in 2 groups and followed for 10 weeks. Results: Among 871 participants who were followed within 10 weeks 97(11.1%) became SARS-CoV-2 positive. there were statistically significant differences between infected or noninfected in the hydroxychloroquine (36 of 97 [37.1%]) and placebo (61 of 97 [62.9 %]) groups with a risk ratio of 2.1 (95% confidence interval (CI) 1.01 -3.21; p = 0.005). The incidence of severe forms of COVID-19 (i.e., hospitalized in the coronavirus ward or the ICU) was 2 of 97 (0.02 %) in participants who received a placebo compared to hydroxychloroquine. The proportion of non-infected people who received hydroxychloroquine prophylaxis was nearly twice higher than that of placebo users (1.87, 95% CI: 1.19 -2.84, p = 0.05). There were no significant differences between the two groups regarding side effects (1.1% vs. 0.9%), and no severe adverse reactions were observed.
Conclusion: Pre-exposure therapy with hydroxychloroquine appears to prevent moderate and severe illness caused by COVID-19 in asymptomatic persons.
Author's contribution data analysis and interpretation: Arezoo Chouhdari; statistical analysis: Arezoo Chouhdari; supervision or mentorship: Termeh Tarjoman, Arezoo Chouhdari; write the first draft of the manuscript: Termeh Tarjoman, Arezoo Chouhdari; All authors contributed to the intellectual content, and manuscript editing and read and approved the final manuscript.
Ethical considerations Questionnaires were filled with the participants' satisfaction and written consent was obtained from the participants in this study.
Conflicts of interest All authors declare no conflict of interest.
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