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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

Journal of Anesthesia & Critical Care: Open Access
Jorge R. Melchor-Amador, MD,1 Eduardo Mota-González, MD,2 Sonia M.Amador-Ayestas, MD,3 Mariely Castelán-López, MD,4 Adriana M.Vidal-Mendez, MD,1 Jessica A. Ojeda Guevara, MD,1 Katy Palma-Vázquez, MD,1 A.Arizahi Ríos-Lina

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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
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


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