Trial *
Publication Sbidian E, medRxiv, 2020
Dates: 2/1/2020 to 4/6/2020
| Methods | |
| Non-randomized study | |
| Location :
Multicenter / France Follow-up duration (days): 28 | |
| Inclusion criteria | All adult (>= 18 years of age) inpatients with at least one polymerase chain reaction-documented SARS-CoV-2 RNA from a nasopharyngeal sample between February 1st, 2020 and April 6th, 2020 were eligible for the present analysis. The date of inclusion in the study cohort (index date) was defined as the date of admission. We restricted the study population to previously hydroxychloroquine- and azithromycin-naive inpatients, defined as those who had not received a prescription before the index date |
| Exclusion criteria | excluded those having received specific COVID-19 treatments, i.e. treatments assessed in ongoing trials: remdesivir, lopinavir-ritonavir (ATC J05AR10), favipiravir (J05AX27), anti-interleukin 1 - i.e., anakinra (ATC L04AC03), canakinumab (ATC L04AC038) - anti-interleukin 6 - i.e., tocilizumab (ATC L04AC037), sarilumab (ATC L04AC14). When patients were transferred between hospitals for the same stay, several discharge reports were available which were analyzed as a single hospital stay until first discharge home. Patients who died or were discharged within 24 hours following their admission were excluded. The end of follow-up was defined by the time of death, discharge home, day 28 (D28) after admission, whichever occurred first, or administrative censoring on May 4, 2020. Patients transferred to hospitals outside AP-HP or to follow-up care and rehabilitation services before day 28 were considered as censored. |
| Type of analysis | Augmented inverse probability of treatment weighting |
| Interventions | |
|
Treatment 1
Hydroxychloroquine + Azithromycin (600mg day 1, 400mg 9 additional days/500mg day 1, 250 4 additional days)Co-Intervention: Standard care Duration : 10 days, 5 days Definition of Standard care: * | |
|
Treatment 2
Hydroxychloroquine (600mg day 1, 400mg 9 additional days)Co-Intervention: Standard care Duration : 10 days, 5 days Definition of Standard care: * | |
| Participants | |
| N analyzed 4019 participants (n1=227 / n2= 3792) | |
| Characteristics of participants N=4642 Mean age : NR 2738 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=* | |
| Primary outcome | |
| In the register NR | |
| In the report all-cause 28-day mortality, assessed as a time-to-event endpoint under a competing risks survival analysis framework | |
| 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 |
Moderate |
| Notes | This is a quasi-experimental study. The baseline data are extracted from table 1. They concern the unadjusted sample (n=4642). The time to death, 28-day mortality, 28-day recovery extracted and time to recovery all concern the AIPTW adjusted sample. No registration, protocolor SAP were available. |