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
Purwati et al.,
A Randomized, Double-Blind, Multicenter Clinical Study Comparing the Efficacy and Safety of a Drug Combination..,
Biochemistry Research International, doi:10.1155/2021/6685921
RCT 754 patients comparing HCQ+AZ along with other treatment groups using lopinavir/ritonavir and doxycycline to a control group taking AZ, finding significantly faster viral clearance with all treatment groups. (The labels in Figure 2 appear to be reversed).
risk of no viral clearance, 66.3% lower, RR 0.34, p < 0.001, treatment 38 of 121 (31.4%), control 111 of 119 (93.3%), NNT 1.6, day 7.
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Purwati et al., 9 Feb 2021, Double Blind Randomized Controlled Trial, Indonesia, peer-reviewed, 12 authors.
Abstract: Hindawi
Biochemistry Research International
Volume 2021, Article ID 6685921, 12 pages
https://doi.org/10.1155/2021/6685921
Research Article
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
Purwati ,1,2 Budiono,2 Brian Eka Rachman,3 Yulistiani,3,4 Andang Miatmoko,1,3
Nasronudin,4 Soroy Lardo,5 Yongki Iswandi Purnama,5 Mafidhatul Laely,6 Ike Rochmad,7
Taufik Ismail,8 Sri Wulandari,8 Dwi Setyawan,3 Alfian Nur Rosyid,4
Herley Windo Setiawan,4 Prastuti Asta Wulaningrum,4 Tri Pudy Asmarawati ,4
Erika Marfiani,4 Shinta Karina Yuniati,4 Muhammad Rabiul Fuadi,4 Pepy Dwi Endraswari,4
Purwaningsih,4 Eryk Hendrianto,1 Deya Karsari,1 Aristika Dinaryanti,1 Nora Ertanti ,1
Igo Syaiful Ihsan,1 Disca Sandyakala Purnama,1 and Yuni Indrayani1
1
Stem Cell Research and Development Center, Airlangga University, Campus C UNAIR, Mulyorejo, Mulyosari,
Surabaya 60115, Indonesia
2
Faculty of Vocational Studies, Airlangga University, Campus B UNAIR, Jl. Dharmawangsa Dalam Selatan, Gubeng,
Surabaya 60286, Indonesia
3
Faculty of Pharmacy, Airlangga University, Nanizar Zaman Joenoes Building, Campus C UNAIR, Mulyorejo, Mulyosari,
Surabaya 60115, Indonesia
4
Airlangga University Hospital, Campus C UNAIR, Mulyorejo, Mulyosari, Surabaya 60115, Indonesia
5
Gatot Soebroto Army Hospital, Jl. Abdul Rahman Saleh, Senen, Jakarta 10410, Indonesia
6
COVID-19 Isolation Center, Lamongan, Indonesia
7
Dustira Hospital, Jl. Dustira, Baros, Cimahi Tengah, Cimahi 40521, Indonesia
8
Polri Hospital, Jl. Raya Bogor, Kramat Jati, Jakarta 13510, Indonesia
Correspondence should be addressed to Purwati; purwati@fk.unair.ac.id
Received 4 November 2020; Revised 14 December 2020; Accepted 15 January 2021; Published 9 February 2021
Academic Editor: Zubeyir Huyut
Copyright © 2021 Purwati et al. This is an open access article distributed under the Creative Commons Attribution License, which
permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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/ritonavirazithromycin, 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 RTPCR 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..
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