Journal of Clinical and Diagnostic Research. 2021 Feb, Vol-15(2): OC27-OC32 27 27 DOI: 10.7860/JCDR/2021/46795.14529 Original Article Internal Medicine Section Use of Ivermectin as a Potential Chemoprophylaxis for COVID-19 in Egypt: A Randomized Clinical Trial INTRODUCTION An outbreak of unknown viral infection began with a cluster of cases complaining severe respiratory symptoms in Wuhan, Hubei, China, during the end of the year 2019. Soon, the causing organism was identified, as novel coronavirus. The virus was named as Severe Acute Respiratory Syndrome-2 (SARS-CoV-2) and the disease caused by it as Coronavirus Disease 2019 (COVID-19). Then, COVID-19 has been considered a global pandemic by the WHO on 11 March, 2020 [1,2]. No consensus on a certain drug therapy for COVID-19 infection has been documented up until now. Currently, many drugs are under clinical trials or empirically included in treatment protocols for COVID-19. Drug repurposing is the most widely used method for rapid response in the face of this pandemic [1]. Trials to invent new medicines might not be feasible is short course of time. Nevertheless, there is a need to protect personnel in close contact with the patients. One of such drug trials was through use of ivermectin, a previously Food and Drug Administration (FDA)-approved drug [3]. Currently, it is under scrutiny for its role in management of COVID-19 in different clinical trials worldwide. As of now, there are more than 36 clinical trials registered all over the world to investigate its role; the authors have two of them [4]. Moreover, ivermectin has been previously approved for management of Onchocerca volvulus and lymphatic filariasis [5]. It is known to have a wide- spectrum antiviral activity against a number of viruses under in vitro investigations [6-9]. Ivermectin has been shown to inhibit the nuclear import of viral proteins. Moreover, it has been demonstrated to limit infection caused by some Ribonucleic Acid (RNA) viruses including influenza, dengue and West Nile viruses. In an in vitro study, ivermectin was found to be an inhibitor of the SARS-CoV-2, with a single addition to Vero/ hSLAM cells 2-hour post infection and able to effect ~5000-fold reduction in viral RNA at 48 hour [3,10]. Moreover, some senior experienced doctors have suggested that ivermectin could be an effective chemoprophylaxis and therapeutic for management of novel coronavirus disease due to its antiviral properties [11]. The rate of secondary attack of SARS-CoV-2 is high among family members in close contact especially the household (about 10-15%) [12]. Social distancing, isolation, and infection control measures are of paramount importance, but might be insufficient. To the best of our knowledge, no reports worldwide studied the possible effects of ivermectin in pre- or post-exposure prophylaxis against SARS-CoV-2. Therefore, the aim of this study was to evaluate possible role of oral ivermectin as a post-exposure chemoprophylactic drug in asymptomatic family members in close contact with COVID-19 patients. MATERIALS AND METHODS The current study was a prospective community-based, interventional randomised open label-controlled investigation; registered at clinicaltrials.gov with number NCT04422561. Chest physicians contributing in this work were responsible for simultaneous randomisation and follow-up of participants, as they diagnosed and referred the index cases. It was carried out at the faculty of Medicine, Zagazig University, Egypt; the period from June 1 to July 28, 2020. The study has been approved by the Institutional Research Board (IRB) of Zagazig Faculty of Medicine under the code: 6150-31-5-2020. A written informed consent was obtained from all participants in the study. A consent was also obtained from the legal guardian of participant/s aged below 18 years. WAHEED M SHOUMANN 1 , ABDELMONEM AWAD HEGAZY 2 , RAMADAN M NAFAE 3 , MOUSTAFA I RAGAB 4 , SAAD R SAMRA 5 , DALIA ANAS IBRAHIM 6 , TAREK H AL-MAHROUKY 7 , ASHRAF E SILEEM 8 Keywords: Close contacts, Control, Coronavirus, Pandemic, SARS-CoV-2 ABSTRACT Introduction: The rate of secondary attacks of SARS-COV-2 is high among household close contacts. Social distancing, isolation and infection control measures are important for preventing exposure to infection, but insufficient. Aim: The study aimed to evaluate possible role of oral ivermectin as a chemoprophylaxis in asymptomatic family close contacts with COVID-19 patients. Materials and Methods: A prospective interventional randomised open label-controlled study was conducted (registered at clinicaltrials.gov; NCT04422561) during June and July 2020. Two arms were designed according to use of ivermectin. In ivermectin arm, contacts received ivermectin according to Body Weight (BW) on day of the diagnosis of their index case. The nonintervention group received no treatment. Both groups were followed-up for two weeks for development of symptoms suggestive of COVID-19. Results: Ivermectin group included 203 contacts (to 52 index cases) aged 39.75±14.94 years; 52.2% were males. Nonintervention group included 101 contacts (to a total of 24 index cases) aged 37.69±16.96 years, 49.5% were males. Fifteen contacts (7.4%) developed COVID-19 in the ivermectin arm compared to 59 (58.4%) in the nonintervention arm (P <0.001). The protection rate for ivermectin was more prominent in contacts aged less than 60-year-old (6.2% infected compared to 58.7% if no treatment). Ivermectin in the protection against SARS-CoV-2 infection had an OR of 12.533 and 11.445 (compared to nontreatment) in both univariate and multivariate models, respectively. Side effects of ivermectin were reported in 5.4%; they were mild. Conclusion: Ivermectin is suggested to be a promising, effective and safe chemoprophylactic drug in management of COVID-19.