Polymerized type I collagen improves the mean oxygen saturation and efficiently shortens symptom duration and hospital stay in adult hospitalized patients with moderate to severe COVID-19: Randomized controlled clinical trial

Background: Abnormal blood-oxygen levels and breathing rates are strong predictors of poor hospitalized patient outcomes. Objective: To evaluate the safety and clinical efficacy of intramuscular administration of polymerized type I collagen (PTIC) in adult hospitalized patients with moderate to severe COVID-19 on mean oxygen saturation and symptom duration. Design, setting, and participants: This randomized, placebo-controlled clinical trial recruited 54 adult hospitalized patients with confirmed COVID-19 diagnosis from June 2020 to May 2021. Patients received intramuscularly 1.5 ml of PTIC (12.5 mg of collagen) or placebo every 24 h for seven days. The primary outcome was oxygen saturation >92% on room air without supplemental oxygen. The secondary outcome was the duration of symptoms. Results: Twenty-two/54 (41%) were male, with a mean age of 43.5±11.9 years. Oxygen saturation >92% on room air without supplemental oxygen was achieved by 23/26 (89.0%) and 15/28 (53.6%) of patients under treatment with PTIC or placebo, respectively (P=0.010). Dyspnea, cough, and chest pain improved from day 4 of treatment vs. baseline (P<0.05). Hospital stay was reduced by 2.77 days in PTIC vs. placebo group (P=0.048). The Neutrophil-to-lymphocyte ratio (NLR) (predictive biomarker for moderate-severe COVID-19) decreased to statistically significant levels (P<0.001 and P=0.009, PTIC and placebo, respectively). No serious adverse events were detected. Conclusion and relevance: In the study, 89% of the patients under PTIC treatment had mean oxygen saturation >92% compared to 53.6% in the placebo group. A shorter duration of the symptoms was determined. A significant decrease in NLR was found in post-treatment with PTIC. The study is limited by a small sample size and short follow-up duration, and determination of clinical efficacy would require larger randomized trials with more definitive outcome measures.