Trial NCT04521309
Publication Ali S, EClinicalMedicine (2021) (published paper)
Dates: 2020-06-19 to 2021-02-03
Funding: Public/non profit (Higher Education Commission (HEC), Pakistan)
Conflict of interest: No

Methods
RCT
Blinding: single blinding
Location : Single center / Pakistan
Follow-up duration (days): 28
Inclusion criteria
  • Above 18 years of age
  • positive SARS-CoV-2 PCR on nasopharyngeal and/or oropharyngeal swabs
  • admitted to the clinical trial site approved tertiary care hospital (isolation ward and ICU)
  • either severely (hospitalized, requiring any supplemental oxygen) or critically (hospitalized, requiring non-invasive ventilation, high-flow oxygen devices or invasive ventilation) ill with Acute Respiratory Distress Syndrome (ARDS) i.e. dyspnea, respiratory rate >=30/min, blood oxygen saturation =<90%, PaO2/FiO2 <300, and lung infiltrates >50% on chest X-ray
Exclusion criteria
  • A history of IgA deficiency, autoimmune disorder, thromboembolic disorder, or allergic reaction to immunoglobulin treatment
  • pregnant females
  • patients requiring two or more inotropic agents to maintain blood pressure
  • patients with acute or chronic kidney injury/failure
  • known case of thromboembolic disorder
  • aseptic meningitis
Interventions
Treatment
C-IVIG
0.15-0.3 g/Kg IV once-off
Control
Standard care

Participants
Randomized
participants :
C-IVIG=40
Standard care=10
Characteristics of participants
N= 50
Mean age : NR
35 males
Severity : Mild: n=0 / Moderate: n=22 / Severe: n=27 Critical: n=1
Number of vaccinated participants: NR
Primary outcome
In the register
28 Days mortality; Requirement of supplemental oxygen support; Number of days on assisted ventilation; Days to step down; Days to Hospital Discharge; Adverse events during hospital stay; Change in C-Reactive Protein (CRP) levels; Change in neutrophil lymphocyte ratio
In the report
28-day mortality; clinical status; PaO2/FiO2 ratio
Documents
available

Protocol

Yes. In English

Statistical plan

NR

Data-sharing willing stated in the publication:

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
Some concerns
General comment In addition to the published article, the study registry and protocol were used in data extraction and risk of bias assessment. The registration was made 2 months after start of recruitment, but nearly 6 months before the end of the study, with no changes to outcomes. The dosages in the registry were changed after completion of the study. The primary outcomes in the report (28-day mortality, patient's clinical status during study duration and Horowitz index at outcome day) are not the same as those in the registry (28 days mortality, requirement of supplemental oxygen support, number of days on assisted ventilation, days to step down and to hospital discharge, adverse events during hospital stay, change in C-Reactive Protein levels, and change in neutrophil lymphocyte ratio; time frame: 28 days). The ordinal scale on which discharge and WHO score 7 or above outcome data are based was not included in the registry or protocol. The article reports a small phase I/II trial that achieved its target sample size.