Trial N/A
Publication Shao Z, medRxiv, 2020
Dates: 12/1/2019 to 3/1/2020
| Methods | |
| Non-randomized study | |
| Location :
Multicenter / China Follow-up duration (days): 60 | |
| Inclusion criteria | Inclusion Criteria: (1) Adult aged >=18 years old; (2) Laboratory (RT-PCR) confirmed SARS-COV-2 infection in throat swab and/or sputum and/or lower respiratory tract samples; or conformed plasma positive of specific antibody (IgM or/and IgG) against SARS-COV-2; (3)In-hospital treatment 72 hours; (4) Meet any one of the following a-c criteria for severe type or d-f criteria for critical type: (a) Respiratory rate >=30/min; or (b) Rest SPO2<=90%; or (c) PaO2/FiO2<=300 mmHg; or (d) Respiratory failure and needs mechanical ventilation; or (e) Shock occurs; or (f) Multiple organ failure and needs ICU monitoring; |
| Exclusion criteria | Exclusion Criteria: (1) Exist of other evidences that can explain pneumonia including but not limited to influenza A virus, influenza B virus, bacterial pneumonia, fungal pneumonia, noninfectious causes, etc.; (2) Women who are pregnant or breast-feeding; (3) Researchers consider unsuitable. |
| Type of analysis | Multivariable logistic regression |
| Interventions | |
| Treatment
Intravenous immunoglobulin (*) |
|
| Control
Standard care Definition of Standard care: * | |
| Participants | |
| N analyzed 325 participants (n1=174 / n2= 151) | |
| Characteristics of participants N=325 Mean age : NR 189 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=222 Critical: n=103 | |
| Primary outcome | |
| In the register NR | |
| In the report 28 day and 60 day mortality | |
| Documents avalaible |
Protocol No Statistical plan No 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 | This is a quasi-experimental study. The baseline data are extracted from Table 1. They concern the unadjusted sample (n=325). 60 day mortality HR is the primary outcome using a multivariate logistic regression adjustment method for analysis. No registration or protocol were available. |