Use of Fibroquel® (Polymerized type I collagen) in patients with hypoxemic inflammatory pneumonia secondary to COVID-19 in Veracruz, Mexico

Abstract

Since the beginning of the pandemic, there is currently no specific treatment, however some drugs, after systematic reviews and meta-analysis have been positioned as potential treatments (dexamethasone, tocilizumab, baricitinib), however, other drugs with therapeutic potential are being investigated, such as Polymerized type I collagen (Fibroquel). Material and methods: Adult patients are admitted to the study from December 2020 to January 2021, with prior informed consent, carriers of viral pneumonia confirmed by axial tomography, secondary to infection by Sars Cov2 virus identified by RT-PCR or antigen test, who also present severity data (dyspnea, desaturation -saturation at room air of 92% or less-, persistent fever), as well as inflammation markers (D-dimer 1000ng/ml±100; ferritin> 300mg) and that allow treatment with Polymerized type I collagen (Fibroquel®) at home or in a hospital area. Results: We include data from 35 patients, 19 (54.3%) women and 16 (45.7%) men, with a median age of 51.0 (38.0-76.0) years. The number of patients with a history of previous comorbidities was 34 (97.1%) and 20 (57.1%) had multiple comorbidities (3 or more synchronous comorbidities). The most frequent comorbidities among these patients were obesity in 94.3%, DM2 62.9%, Arterial hypertension 60.0%, COPD 14.3%, heart disease 8.6%, nephropathy 5.7%, in addition to SLE and trisomy 21, both in 2.9% of patients. In the baseline evaluation laboratory, we found that 33 (94.3%) patients had lymphocytopenia and 3 (8.6%) had thrombocytopenia. Median D-Dimer and Ferritin serum levels were 1,200.0 (990.0- 1,800.0) ng/mL and 394.5 (320.0-492.5) ug/L, respectively. The neutrophil-lymphocyte index was calculated, which on average was 10.8 (8.0 - 14.7) and an ABC-GOALSclx index of 14.0 (11.0 - 16.0) was calculated, which translate severe disease and an indication of stay in an intensive care unit. Relation to the pulse oximetry at ambient air in the baseline evaluation, we found that the median O2 saturation was 88.0% (86.0% - 89.0%). The median number of days of evolution from the onset of symptoms to the moment in which treatment with Fibroquel was started was 8.0 (7.0-9.0) days. The pulse oximetry quantified 7 days after the start of treatment had a median of 94.0% (93.0-95.0%); Regarding the measurement of prognostic biomarkers, the median d-dimer and ferritin in serum measured at 7 days of follow-up were 656.0 (497.0 - 697.5) ng/mL and 394.5 (320.0-492.5) ug/L, respectively. Conclusion: Polymerized type I collagen (Fibroquel) is an effective drug in patients with inflammatory and hypoxemic pneumonia secondary to Sars COV 2 infection, favoring clinical improvement and favoring extubation, oxygenation, and inflammation indices, as well as a biosafety profile that ensures its use without restrictions in these patients.

An Update on the Clinical Efficacy and Safety of Collagen Injectables for Aesthetic and Regenerative Medicine Applications

“…While bovine collagen is used for many purposes, porcine collagen is almost exclusively used for the treatment of diseases belonging to the musculoskeletal apparatus [ 130 , 131 , 132 , 133 , 134 , 135 , 136 , 137 , 138 , 139 , 140 , 141 , 142 , 143 , 144 , 145 , 146 ] (NCT02539030, NCT02519881, NCT02539095), followed by the integumental apparatus [ 67 , 76 , 86 , 87 , 147 , 148 , 149 , 150 , 151 , 152 ] (NCT03844529, NCT00891774, NCT00929071) and gastrointestinal apparatus [ 116 , 117 , 153 , 154 , 155 , 156 , 157 , 158 , 159 ]. Only recently porcine collagen potential has been explored for the treatment of facial nerve palsy [ 160 ] and for the treatment of COVID-19 due hyperinflammation [ 161 , 162 ] (NCT04517162). However, despite their wide use and effectiveness, bovine and porcine collagens suffer from cultural or religious concerns (bovine collagen: Sikh, Buddhism; porcine collagen: Jewish, Islamic faiths), which restricted their applicative potential [ 18 , 19 ].…”

“…New experimentations using collagen-based formulations were performed for non-standard clinical applications such as facial nerve rehabilitation after palsy [ 160 , 211 ], organ protection during thermal ablation [ 129 ], COVID-19 related hyperinflammation [ 161 , 162 ] (NCT04517162), artery aneurysms closure [ 128 , 213 ], blood volume augmentation [ 127 , 214 ] and the treatment of chronic ischemic heart diseases [ 226 ].…”

“…Intramuscular injection of collagen (Fibroquel ® ) was able to significantly decrease the interferon gamma-induced protein 10 (IP-10), IL-8, macrophage colony-stimulating factor (M-CSF), high-sensitivity C-reactive protein (hsCRP), D-dimer and lactate dehydrogenase (LDH) levels, in the first week of treatment [ 162 ] (NCT04517162). Moreover, collagen injections were associated with better oxygen saturation values and shortened symptom duration, extubation and reduced inflammation when compared to placebo [ 161 , 162 ] (NCT04517162). Thus, collagen-based injections were considered safe and well-tolerated and did not induce liver damage, infections, impairment of hematopoiesis or blood alterations [ 161 , 162 ] (NCT04517162).…”

“…Moreover, collagen injections were associated with better oxygen saturation values and shortened symptom duration, extubation and reduced inflammation when compared to placebo [ 161 , 162 ] (NCT04517162). Thus, collagen-based injections were considered safe and well-tolerated and did not induce liver damage, infections, impairment of hematopoiesis or blood alterations [ 161 , 162 ] (NCT04517162).…”

“…Porcine derived collagen-based products (i.e., Cartifil, Cartizol, Fibroquel, Permacol and MD products) revealed to not trigger severe adverse events (no cases on 751 procedures) and to be responsible for the 9.2% of mild adverse events (69 cases on 751 procedures) [ 131 , 132 , 133 , 134 , 135 , 136 , 138 , 140 , 141 , 143 , 145 , 146 , 153 , 154 , 155 , 156 , 157 , 160 , 161 , 162 , 182 , 204 ] (NCT02539030, NCT02539095, NCT04019782, NCT03323567, NCT02539082, NCT01528995, NCT04517162, NCT04353908). Mild adverse events could be due both to collagen type or to other components (i.e., glucose, CaCl, amino acids, vitamin B, fibrin glue for Cartifil/Cartizol; polyvinylpyrrolidone for Fibroquel) or to the injection procedure.…”