Safety and efficacy of Fibroquel® (polymerized type I collagen) in adult outpatients with moderate COVID-19: an open-label study

Abstract

Background: SARS-CoV-2 infection induces a hyperinflammatory syndrome, causing acute respiratory distress syndrome, and clinical deterioration. The current therapeutic investigation has been focusing on the development of novel immunosuppressant therapies to control cytokine production. Objective: To evaluate the safety and clinical effect of intramuscular administration of polymerized type I collagen in adult outpatients with moderate COVID-19. Design, setting, and participants: This was an open-label study that recruited 20 adult patients with confirmed COVID-19 diagnosis, from June 16, 2020 to September 20, 2020. The final date of follow-up was November 4, 2020. Interventions: Patients received intramuscularly 1.5 ml of polymerized type I collagen (12.5 mg of collagen) every 12 h for 3 days and then every 24 h for 4 days. Main outcomes and measures: The primary outcome was oxygen saturation >92% on room air without supplemental oxygen. The secondary outcome was the duration of symptoms. Results: Of 20 patients who were recruited, 9 (45%) were male, with mean age of 49.5±11.2 years. Oxygen saturation >92% on room air without supplemental oxygen was achieved by 18 (90%) and 19 (95%) of patients at day 1 and 8 post-treatment with polymerized type I collagen (P=0.001). Most of the symptoms improved from day 3 of treatment concerning baseline. The neutrophil-to-lymphocyte ratio (NLR) and lactate dehydrogenase (LDH) (predictive biomarkers for moderate-severe COVID-19) decreased to statistically significant levels at day 8 post-treatment (P=0.023 and P=0.011, respectively). No serious adverse events were detected. Conclusion and relevance: In the study more than 90% of the patients had mean oxygen saturation >92%. A shorter duration of the symptoms was determined. A significant decrease in NLR and LDH was also found. The study is limited by small sample size and short follow-up duration, and determination of clinical efficacy would require larger randomized trials with more definitive outcome measures.