학술논문
A Randomized, Double-Blind, Multicenter Clinical Study Comparing the Efficacy and Safety of a Drug Combination of Lopinavir/Ritonavir-Azithromycin, Lopinavir/Ritonavir-Doxycycline, and Azithromycin-Hydroxychloroquine for Patients Diagnosed with Mild to Moderate COVID-19 Infections
Document Type
article
Author
Purwati; Budiono; Brian Eka Rachman; Yulistiani; Andang Miatmoko; Nasronudin; Soroy Lardo; Yongki Iswandi Purnama; Mafidhatul Laely; Ike Rochmad; Taufik Ismail; Sri Wulandari; Dwi Setyawan; Alfian Nur Rosyid; Herley Windo Setiawan; Prastuti Asta Wulaningrum; Tri Pudy Asmarawati; Erika Marfiani; Shinta Karina Yuniati; Muhammad Rabiul Fuadi; Pepy Dwi Endraswari; Purwaningsih; Eryk Hendrianto; Deya Karsari; Aristika Dinaryanti; Nora Ertanti; Igo Syaiful Ihsan; Disca Sandyakala Purnama; Yuni Indrayani
Source
Biochemistry Research International, Vol 2021 (2021)
Subject
Language
English
ISSN
2090-2247
2090-2255
2090-2255
Abstract
Background. At the present time, COVID-19 vaccines are at the testing stage, and an effective treatment for COVID-19 incorporating appropriate safety measures remains the most significant obstacle to be overcome. A strategic countermeasure is, therefore, urgently required. Aim. This study aims to evaluate the efficacy and safety of a combination of lopinavir/ritonavir-azithromycin, lopinavir/ritonavir-doxycycline, and azithromycin-hydroxychloroquine used to treat patients with mild to moderate COVID-19 infections. Setting and Design. This study was conducted at four different clinical study sites in Indonesia. The subjects gave informed consent for their participation and were confirmed as being COVID-19-positive by means of an RT-PCR test. The present study constituted a randomized, double-blind, and multicenter clinical study of patients diagnosed with mild to moderate COVID-19 infection. Materials and Methods. Six treatment groups participated in this study: a Control group administered with a 500 mg dose of azithromycin; Group A which received a 200/50 mg dose of lopinavir/ritonavir and 500 mg of azithromycin; Group B treated with a 200/50 mg dose of lopinavir/ritonavir and 200 mg of doxycycline; Group C administered with 200 mg of hydroxychloroquine and 500 mg of azithromycin; Group D which received a 400/100 mg dose of lopinavir/ritonavir and 500 mg of azithromycin; and Group E treated with a 400/100 mg dose of lopinavir/ritonavir and 200 mg of doxycycline. Results. 754 subjects participated in this study: 694 patients (92.4%) who presented mild symptoms and 57 patients (7.6%) classified as suffering from a moderate case of COVID-19. On the third day after treatment, 91.7%–99.2% of the subjects in Groups A–E were confirmed negative by a PCR swab test compared to 26.9% in the Control group. Observation of all groups which experienced a significant decrease in virus load between day 1 and day 7 was undertaken. Other markers, such as CRP and IL-6, were significantly lower in all treatment groups (p