Trial *
Publication Giacomelli A, J Med Virol , 2020
Dates: 2020-02-21 to 2020-03-20
| Methods | |
| Non-randomized study | |
| Location :
Single center / Italy Follow-up duration (days): 30 | |
| Inclusion criteria | patients with COVID-19 pneumonia who were hospitalised at Luigi Sacco Hospital, Milan, Italy, between 21 February and 20 March 2020. COVID-19 pneumonia was diagnosed on the basis of the detection of SARS-CoV-2 RNA on nasopharyngeal swab using a real-time reverse-transcriptase polymerase chain reaction (RT-PCR) test processed using the automated ELITe InGenius system and the GeneFinder COVID-19 Plus RealAmp Kit assay (ELITechGroup, Puteaux, France) and a chest X-ray with signs of pneumonia or ≤93% oxygen saturation (SpO2) while breathing room air |
| Exclusion criteria | The exclusion criteria were the presence of any condition that would not allow the treatment to be safely administered (including any known allergy or hypersensitivity to the drugs used in the protocol); severe liver or kidney disease; the use of medications contraindicated with LPV/r that could not be replaced or discontinued; pregnancy or breast-feeding; known HIV infection; a history of cardiomyopathy, arrhythmias or conduction disorders; and a history of ocular macular disease or retinal damage. |
| Type of analysis | Multivariable logistic re |
| Interventions | |
|
Treatment 1
LPV/r+HCQ early (400/100mg+200 mg) Duration : The median dura | |
|
Treatment 2
LPV/r+HCQ delayed (400/100mg+200 mg) Duration : The median duraThe median dura | |
| Participants | |
| N analyzed 172 participants (n1=43 / n2= 129) | |
| Characteristics of participants N=* Mean age : NR 124 males Severity : Mild: n=14 / Moderate: n=92/ Severe: n=60 Critical: n=6 | |
| Primary outcome | |
| In the register NR | |
| In the report Clinical improvement | |
| Documents avalaible |
Protocol NR Statistical plan NR Data-sharing stated Yes |
| 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 |
Serious |
| Notes | * |