Attenuation of serum inflammatory cytokines in hospitalized COVID-19 patients treated with NRICM101: A preliminary observational study.
TL;DR
NRICM101 administration was associated with reduced serum levels of key proinflammatory cytokines, indicating a potential anti-inflammatory effect, and may serve as an adjunctive therapy for patients with COVID-19-related hyperinflammation.
Abstract
Background
SARS-CoV-2 infection can induce a hyperinflammatory response through excessive cytokine release, contributing to disease severity and mortality. NRICM101, a government-endorsed multi-herbal traditional Chinese medicine formula, has shown promising immunomodulatory and antiviral effects in preclinical studies. However, clinical evidence on its effect on inflammatory biomarkers in COVID-19 patients remains limited.
Methods
To evaluate the clinical effects of NRICM101, we conducted a prospective observational study with non-randomized treatment allocation based on patient consent. A total of 51 hospitalized patients infected with the Alpha variant of SARS-CoV-2 in northern Taiwan (April-June 2021) were included. Fourteen patients received NRICM101 in addition to standard supportive care, while 37 received standard care alone. Serum cytokines-IL-6, IL-16, IP-10, MCP-1, and PDGF-BB-were measured using multiplex immunoassay. Clinical data including disease progression, oxygen requirement, length of hospitalization, and mortality were collected and analyzed.
Results
Patients in the NRICM101 group showed significantly lower levels of IL-6 (p = 0.033) and IL-16 (p = 0.040) compared to controls. IP-10 and MCP-1 levels exhibited downward trends without reaching statistical significance. Despite a higher baseline rate of respiratory failure in the NRICM101 group (35.7% vs. 5.4%; P = 0.005), clinical outcomes were comparable between the groups.
Conclusions
NRICM101 administration was associated with reduced serum levels of key proinflammatory cytokines, indicating a potential anti-inflammatory effect. Clinical outcomes were comparable between the two groups. NRICM101 may serve as an adjunctive therapy for patients with COVID-19-related hyperinflammation and warrants further evaluation in larger randomized trials.