Trial NCT04411667
Publication Sakoulas G, Crit Care Expl (2020) (published paper)
Dates: 2020-05-01 to 2020-06-16
Funding: drug donation only (no specific funding, IVIG (Octagam 10%) was provided by Octapharma USA, Hoboken, NJ (donation))
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / USA
Follow-up duration (days): 30
Inclusion criteria
  • Adult patients > 18 years of age presenting with COVID-??19 infection confirmed by positive polymerase chain reaction testing for SARS-??CoV2 genome in nasopharyngeal or oropharyngeal swab sample were considered for inclusion if they demonstrated moderate to severe hypoxia (sPO2 <96% on > 4 liters O2 by nasal cannula) but not on mechanical ventilation. This corresponds to FiO2 of 37% to maintain a PaO2 of 90 mm Hg (alveolar-??arterial [A-??a] gradient of 120 mm Hg or PaO2/FiO2 243).
Exclusion criteria
  • Quote from the registry
    Severe allergy to any IVIG product formulation
    History of DVT, PE, thromboembolic stroke or other thrombotic events Hypersensitivity to corn. Octagam?? contains maltose which is a sugar derived from corn.
    Uncontrolled hypertension (SBP>180 mm Hg or DBP>120mmHg)
    Active participant in another research treatment study
    Mechanically ventilated patient
    Code status is Do Not Resuscitate or Do Not Intubate
Interventions
Treatment
IV Ig
0.5 g/kg IV once a day for 3 days
Control
Standard care

Participants
Randomized
participants :
Standard care=17
IV Ig=17
Characteristics of participants
N= 34
Mean age : NR
20 males
Severity : Mild: n=0 / Moderate: n=7 / Severe: n=26 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Mechanical Ventilation [ Time Frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days ]
In the report
Respiratory failure requiring receipt of mechanical ventilation (a composite of either receiving ventilation or the subject status changed to a do not resuscitate/do not intubate resulting in progressive respiratory failure and death)
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:
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 all available versions of the published article, the study registry was used in data extraction. The protocol or and statistical analysis plan were available. There is no change from the trial registration in the intervention and control treatments.
Quote: "For subjects not already receiving glucocorticoid therapy, enrolled treatment arm subjects received methylprednisolone 40 mg IV once 30 minutes before IVIG to mitigate headache commonly experienced after IVIG therapy."
Quote: "Immediately after randomization and notification of the principal investigator, one subject was immediately deemed unevaluable by the principal investigator and excluded due to a high risk of bacterial superinfection (elevated absolute neutrophil count of 9900/mm3 and concomitant procalcitonin of 1.45 ng/mL).
On August 25th, 2020 we received additional information from authors on this study.