Trial N/A
Publication Ip A, medRxiv, 2020
Dates: 3/1/2020 to 5/5/2020
| Methods | |
| Non-randomized study | |
| Location :
Multicenter / USA Follow-up duration (days): * | |
| Inclusion criteria | 1) Positive SARS-CoV-2 diagnosis by reverse-transcriptase polymerase chain reaction, 2) Hospitalized within the time frame of March 1, 2020 until May 5, 2020, 3) Non-pregnant, 4) Not on a randomized clinical trial, and 5) Did not die during first day of hospitalization, and 5) Were not discharged to home within 24 hours. |
| Exclusion criteria | 1. SARS-CoV2 infection not confirmed positive (n=85)2. Pregnancy (n=43)3. On Clinical trial (n=88)4. No date for hospital admission or admission after May 5 (n=221)5. Discharged on day of admission (n=337)6. Death within 1 day of admission (n=39) |
| Type of analysis | Propensity score stratification |
| Interventions | |
|
Treatment 1
Azithromycin ("at prescribers? discretion" ) Duration : "at prescribers? discretion" Definition of Standard care: * | |
|
Treatment 2
Hydroxychloroquine + Azithromycin ("at prescribers? discretion" ) Duration : "at prescribers? discretion" Definition of Standard care: * | |
|
Treatment 3
Hydroxychloroquine ("at prescribers? discretion" ) Duration : "at prescribers? discretion" Definition of Standard care: * | |
|
Treatment 4
Tocilizumab ("at prescribers? discretion" ) Duration : "at prescribers? discretion" Definition of Standard care: * | |
| Participants | |
| N analyzed 598 participants (n1=256 / n2= 342) | |
| Characteristics of participants N=2512 Mean age : NR 0 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=* | |
| Primary outcome | |
| In the register NR | |
| In the report death with follow-up through May 5, 2020 | |
| Documents avalaible |
Protocol No Statistical plan Yes Data-sharing stated No |
| 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 a non randmized study. The baseline data are extracted from Table 1. They concern the unadjusted sample (n=2512). The time to death HR extracted concerns the prospensity score with multivariate logistic regression adjusted sample for each arm. The model for the HCQ only arm differs from that for the HCQ+AZM and AZM only arms. No registration or protocol were available. SAP and data output were available. |