IVIg Investigator Initiated Studies

Clinical Trial: IVIg Treatment for Respiratory Failure

An investigator-initiated clinical trial led by George Sakoulas, M.D., of Sharp Memorial Hospital in San Diego, studied the use of IVIg as a coronavirus pandemic treatment for adults experiencing respiratory failure. Supported by Octapharma USA, the research focused on treating the most critical patients at the heart of the coronavirus pandemic, those experiencing respiratory failure, becoming dependent on ventilators.

Specifically, the study investigated whether or not IVIg treatment can halt COVID-19 progression to respiratory failure requiring patient transfer into intensive care and use of mechanical ventilation, and whether adding IVIg to the standard of care can reduce the number of days requiring oxygen therapy and the duration of hospital stay.

Study Design¹

• Randomized prospective open-label study
• Patients had positive COVID-19 PCR test
• Patients were admitted to floor or ICU requiring oxygen of ≥4 liters NC for O2 saturation ≥96% but NOT INTUBATED
• Patients were randomized into one of 2 groups:
  • Standard of care (SOC) arm: SOC included any intervention deemed appropriate for COVID-19 treatment that DID NOT INCLUDE an investigational agent that is part of another randomized trial
  • IVIg arm: SOC plus IVIg 0.5 g/kg/d x 3 days
• Endpoints included the need for mechanical ventilation, death due to other causes before ventilation, or hospital discharge

Preliminary Results¹

• 15 patients per arm at time of analysis
• 6 patients in the SOC arm required intubation for 80 cumulative ventilator-dependent patient days and 2 patients in the IVIg arm required intubation for 15 cumulative ventilator-dependent patient days
• All of the first 5 patients enrolled in the IVIg arm during the first week of May have been discharged home and are breathing independently on room air
• Of the first 5 patients enrolled in the SOC arm, one has died, one has been discharged home, one remains ventilator-dependent, and two are hospitalized on a medical floor

Final Results¹

• There were 17 patients in the SOC arm,16 in the IVIg arm, well matched by age, gender, ethnicity, comorbidities and illness severity
• The use of IVIg (0.5 g.kg.d x 3 days) reduced the rate of progression of respiratory failure requiring mechanical ventilation in COVID-19 patients (13% with IVIg vs 41% without IVIg, p=0.12)
• Data becomes statistically significant when applied to patients with enrollment A-a gradient ≥ 200 (14% with IVIg vs. 58% without IVIg, p=0.038)
• Treatment with IVIg also shortened hospital length of stay, ICU length of stay, and improvement in oxygenation at day 7
• Sample size was too small to see an effect on mortality (1/16 IVIg vs 3/17 SOC)
• Limitations include: the study population was homogenous reflective of COVID-19 demographics in San Diego, the study was not blind, the concomitant use of methylprednisolone may have confounded the results

Clinical Trial: IVIg Treatment for Myocardial Dysfunction

In addition to pulmonary distress, severely and critically ill COVID-19 patients may develop myocardial dysfunction, specifically, elevated cardiac biomarkers and evidence of left ventricular (LV) damage. An investigator-initiated research study led by Kelly McCants, M.D., Medical Director of the Norton Heart & Vascular Institute in Louisville, Kentucky, is investigating the use of IVIg treatment and steroids as a possible treatment regimen for patients developing heart problems.

Learn more about this effort, supported by Octapharma and BioMatrix.