Trial N/A
Publication Geleris J, N Engl J Med, 2020
Dates: 3/7/2020 to 4/25/2020
Methods | |
Non-randomized study | |
Location :
Single center / USA Follow-up duration (days): 23 | |
Inclusion criteria | All admitted adults who had a positive test result for the virus SARS-CoV-2 from analysis of nasopharyngeal or oropharyngeal swab specimens obtained at any point during their hospitalization from March 7 to April 8, 2020. |
Exclusion criteria | Patients who were intubated, died, or were discharged within 24 hours, or were directly admitted to alternative facilities within 24 hours after presentation to the emergency department. |
Type of analysis | Propensity score matching |
Interventions | |
Treatment
Hydroxychloroquine (600mg initial 400mg maintenance) Co-Intervention: Standard care Duration : 5 days |
|
Control
Standard care Definition of Standard care: Patients received various other medications, including: statins, ACE inhibitors/ARBs, glucocorticoids, anticoagulants, antibiotics including azithromycin, remdesivir, tocilizumab. | |
Participants | |
N analyzed 1085 participants (n1=811 / n2= 274) | |
Characteristics of participants N=1085 Mean age : NR 635 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
Primary outcome | |
In the register NR | |
In the report The time from study baseline to intubation or death. For patients who died after intubation, the timing of the primary end point was defined as the time of intubation. | |
Documents avalaible |
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 |
Serious |
Notes | This is an emulated trial. The treatment group was defined as all participants receiving hydroxychloroquine at study baseline or during the follow-up period before intubation or death (i.e., the primary composite outcome). Study baseline was defined as 24 hours after arrival at the emergency department. We extracted data for the primary analysis reported in the paper (propensity score with inverse probability weighting). Secondary analyses include propensity score matching. We extracted baseline data from the unadjusted data columns in Table 1. All patients in both arms were cared for in the same hospital, we therefore extracted 'standard care' as present in both arms. |