Intramuscular Effect of Polymerized Type I Collagen on the Cytokine Storm in COVID-19 Patients

Summary

SARS-CoV-2 infection induces a hyperinflammatory syndrome, causing the acute respiratory distress syndrome, massive lung cell destruction and, as a plausible sequelae, pulmonary fibrosis in COVID-19 patients.

Current focus has been on the development of novel immunosuppressant therapies, in order to control the cytokine storm in COVID-19 patients. Thus, the effect of steroids, intravenous immunoglobulin, non-steroidal immunosuppressants, selective cytokine blockade, JAK/STAT pathway inbhibition, and mesenchymal precursor cells have been evaluated. Based on the above information, we propose COLLAGEN-POLYVINYLPYRROLIDONE (Distinctive name: FibroquelMR, active substance: Collagen-polyvinylpyrrolidone, pharmaceutical form: intramuscular injectable solution, with sanitary registration No. 201M95 SSA IV and SSA code: 010 000 3999) as a potential drug for the downregulation of the cytokine storm. Polymerized type I collagen reduces the expression of IL-1β, IL-8, TNF-alpha, TGF-β1, IL-17, Cox-1, leukocyte adhesion molecules (ELAM-1, VCAM- 1 and ICAM-1), some other mediators of inflammation and increases the levels of IL-10 and the number of regulatory T cells. In addition, it promotes the mechanisms of inhibition of tissue fibrosis, without adverse effects in rheumatoid arthritis and osteoarthritis.

Conditions

• Covid19
• Cytokine Storm
• Regulation of Inflammatory Response
• Pulmonary Fibrosis

Interventions

DRUG

Collagen-Polyvinylpyrrolidone

1.5 mL of polymerized-type I collagen or placebo, every 12 h for 3 days and then every 24 h for 4 days (in total 10 injections in 7 days)

Sponsors & Collaborators

• Janette Furuzawa Carballeda

  lead OTHER

Principal Investigators

• Eric Ochoa-Hein, MD · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

• Luis A Septien-Stute, MD · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

• Janette Furuzawa-Carballeda, PhD · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

• Gonzalo Torres-Villalobos, MD, PhD · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

• Daniel Azamar-Llamas, MD · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

• Diego F Hernández-Ramírez, PhD · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

• Elizabeth Olivares-Martínez, PhD · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-19

Primary Completion

2021-02-19

Completion

2021-06-19

Countries

• Mexico

Study Locations