Trial NCT04411667
Publication Sakoulas G, Crit Care Expl , 2020 (published paper)
Dates: 2020-05-01 to 2020-06-16
Funding: Private (IVIG (Octagam 10%) was provided by Octapharma USA, Hoboken, NJ)
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
Intravenous Immunoglobulin 0.5 g/kg IV once a day for 3 days |
|
| Control
Standard care Definition of Standard care: SOC consisted of the subject remaining on or being eligible for any treatment not part of a randomized clinical trial at the time of enrollment. On May 13, 2020 and afterwards, this included the use of remdesivir. Subjects were also allowed to receive convalescent plasma therapy as part of the nationally available compassionate use registry. | |
| Participants | |
| Randomized 34 participants (n1=17 / n2= 17) | |
| Characteristics of participants N=34 Mean age : 54 20 males Severity : Mild: n=0 / Moderate: n=7/ Severe: n=26 Critical: n=0 | |
| 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 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 |
Some concerns |
| General comment |
In addition to all available versions of the published article, the study registry was used in data extraction. No protocol or pre-specified statistical analysis plan are 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. |