Trial INA-TX6YYSS
Publication Purwati, 2021 (published paper)
Funding: Public/non profit (Indonesian Intelligence Agency)
Conflict of interest: No
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Multicenter / Indonesia Follow-up duration (days): * | |
| Inclusion criteria | Male or female adults over the age of 18;
Positive result on the COVID-19 PCR swab test; Presented mild, moderate, or severe symptoms; Willing to give informed consent |
| Exclusion criteria | Pregnant or breastfeeding mothers;
Individuals with severe liver disorders (indicated by increases in transaminases levels three times or more in excess of the normal range); Impaired renal functions (indicated by decreases in creatinine clearance of less than 60 mL/minute); Arrhythmia, and/or a compromised potassium/magnesium balance |
| Interventions | |
| Treatment 1 Lopinavir-Ritonavir(Low dose)+Azithromycin | |
| Control Azithromycin | |
| Treatment 3 Lopinavir-Ritonavir(Low dose)+Doxycycline | |
| Treatment 4 Hydroxychloroquine+Azithromycin | |
| Treatment 5 Lopinavir-Ritonavir+Azithromycin | |
| Treatment 6 Lopinavir-Ritonavir+Doxycycline | |
| Participants | |
| Randomized 759 participants n1=128/ n2=119/ n3=129/ n4=123/ n5=131n6=129 | |
| Characteristics of participants N=759 Mean age : NR 721 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=* | |
| Primary outcome | |
| In the register Percentage of patients who have improved clinical outcome and/or decreased mortality (first come first counted) | |
| In the report Improvements in such physical functions as maintaining optimum body temperature (<37.5C); respiratory rate (≤20 times per minute without the use of auxiliary respiratory muscles); oxygen saturation/SpO2 (>95% without provision of supplemental oxygen); and hemodynamic stability (mean arterial pressure/MAP >65 mmHg). Moreover, the decrease in mortality rate was noted to establish the efficacy of drug combination therapy. | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated NR |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
* |
| General comment |
This study is pending contact with authors. No review-specific outcomes reported/extracted.
In addition to the published article, the study registry (in Bahasa Indonesia) was used in data extraction and risk of bias assessment. Protocol and statistical analysis plan were not available. The target sample size specified in the registry was achieved. Mortality was listed as an outcome in the registry but was not reported. Viral negative conversion was reported, but not in a way that could be extracted. There were no significant changes from the trial registration in the intervention and control treatments. The overall follow-up of the study was unclear. |