Patients with moderate pneumonia due to COVID-19 showed significant clinical improvement with intravenous immunoglobulin (IVIG) in addition to standard of care treatment compared with standard of care treatment alone, according to a small study published in the Journal of Infectious Diseases.
In this randomized, open-label, phase 2 study, patients across 4 centers in India were randomly assigned in a 1:1 ratio to receive either IVIG plus standard of care treatment (experimental group, n=50) or standard of care treatment alone (control group, n=50) to determine the safety and efficacy of IVIG therapy for treating moderate COVID-19 pneumonia.
The primary outcome was the number of days of hospitalization. Secondary outcomes included number of days on mechanical ventilation, days until cessation of cough, duration of stay at an intensive care unit, and the number of days it took to achieve normal body temperature, oxygen level, and respiratory rate.
Of the 100 patients included in the study, 67% were men and the mean age was 48.7 years. The 2 groups were similar in age, sex, BMI, and comorbidity distribution. In addition, there was no difference in hematological and biochemical parameters both at baseline and end of study, which was 28 days from initiation of treatment.
The mean days of hospitalization was significantly lower in the experimental vs control group (7.72 vs 17.50 days; P =.0001). With the exception of the number of days needed to achieve normal respiratory rate and duration of intensive care unit stay, the mean days for the remaining secondary outcomes were also significantly lower in the experimental vs control group:
- Days until cessation of cough: 3.52 vs 6.67 (P =.0001)
- Days to achieve normal body temperature: 2.18 vs 5.45 (P =.005)
- Days on mechanical ventilation: 2.42 vs 4.47 (P =.01)
- Days to achieve normal oxygen level: 2.45 vs 4.75 (P =.03)
At day 14, 92% of patients in the experimental group tested negative for COVID-19 vs 24% of patients in the control group. At day 28, no one in the experimental group tested positive for COVID-19, while 6% of patients tested positive in the control group. The median time to a negative COVID-19 test was significantly shorter in the experimental vs control group (7 vs 18 days).
Except for one patient who died in the control group, adverse events across both groups were mild-to-moderate in nature.
Limitations of this study included a small sample size and no follow-up with patients upon hospital discharge.
“The results of this study have shown that initiation of IVIG as adjuvant treatment for COVID-19 patients with moderate pneumonia can reduce the number of days to clinical improvement,” the researchers concluded.
Disclosure: This trial was financially supported by Virchow Biotech. Several study authors declared affiliations with Virchow Biotech.
Raman RS, Barge VB, Darivenula AK, et al. A phase II safety and efficacy study on prognosis of moderate pneumonia in COVID-19 patients with regular intravenous immunoglobulin therapy. J Infect Dis. Published online February 15, 2021. doi:10.1093/infdis/jiab098