Pirfenidone LP or Collagen-polyvinylpyrrolidone in COVID-19

NCT06585319 | Completed Phase 2 DMC

• 1 other identifier: 2020-12-713
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Collagen-polyvinylpyrrolidone (collagen-PVP) and pirfenidone have the ability to control cytokine storms. This work explores the therapeutic effects of both, on the early treatment of patients with severe COVID-19. The hospital stay, quick COVID-19 severity index (qCSI) and admission to the ICU were statistically significantly lower when the patients were treated with collagen-PVP or pirfenidone, compared to the controls treated with dexamethasone alone.

Conditions

COVID 19

Keywords

collagen-polyvinylpyrrolidone; pirfenidone; survival; immunomodulation

Outcome Measures

Primary Outcomes (1)

• Number of patients that survived the COVID-19 infection

  After each of the treatments that were given for seven days, the evolution of the patients was recorded.

  From enrollment until one month of follow up

Study Arms (3)

Collagen-polyvinylpyrrolidone

EXPERIMENTAL

Collagen-PVP ml intramuscular q24 h

Drug: Collagen-polyvinylpyrrolidone

Pirfenidone

ACTIVE COMPARATOR

Pirfenidone 1,200 mg of oral q12 h

Drug: Pirfenidone 1200 mg

Control

NO INTERVENTION

Standard treatment with dexamethasone (intravenously) and 40 or 60 mg of enoxaparin (subcutaneously, according to the patient's weight) once daily and 1 g of paracetamol

Interventions

Collagen-polyvinylpyrrolidone DRUG

2 ml intramuscular q24 h

Collagen-polyvinylpyrrolidone

Pirfenidone 1200 mg DRUG

1,200 mg of oral q12 h

Pirfenidone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients infected with SARS-CoV-2, hospitalized, with total bilirubin ≤1.5

You may not qualify if:

• if the patient underwent treatment with biological antirheumatic drugs, disease modifiers (DMARDs) or other immunosuppressive agents, patients who required continuous therapy with systemic corticosteroids in a dose greater than 10 mg of prednisone per day or equivalent; pregnant women, calculated creatinine clearance (or estimated glomerular filtration rate less than 10 ml/min or patients requiring renal replacement therapy

Sponsors & Collaborators

• Materno-Perinatal Hospital of the State of Mexico: lead

Study Sites (1)

Monica Pretelini Saenz Maternal Perinatal Hospital

Toluca, State of Mexico, 50120, Mexico

Location

Related Publications (4)

• Leyva-Gomez G, Lima E, Krotzsch G, Pacheco-Marin R, Rodriguez-Fuentes N, Quintanar-Guerrero D, Krotzsch E. Physicochemical and functional characterization of the collagen-polyvinylpyrrolidone copolymer. J Phys Chem B. 2014 Aug 7;118(31):9272-83. doi: 10.1021/jp502476x. Epub 2014 Jul 30.

  PMID: 25051159 BACKGROUND

• Olmos-Zuniga JR, Silva-Martinez M, Jasso-Victoria R, Baltazares-Lipp M, Hernandez-Jimenez C, Buendia-Roldan I, Jasso-Arenas J, Martinez-Salas A, Calyeca-Gomez J, Guzman-Cedillo AE, Gaxiola-Gaxiola M, Romero-Romero L. Effects of Pirfenidone and Collagen-Polyvinylpyrrolidone on Macroscopic and Microscopic Changes, TGF-beta1 Expression, and Collagen Deposition in an Experimental Model of Tracheal Wound Healing. Biomed Res Int. 2017;2017:6471071. doi: 10.1155/2017/6471071. Epub 2017 May 11.

  PMID: 28584818 BACKGROUND

• Furuzawa-Carballeda J, Cabral AR, Zapata-Zuniga M, Alcocer-Varela J. Subcutaneous administration of polymerized-type I collagen for the treatment of patients with rheumatoid arthritis. An open-label pilot trial. J Rheumatol. 2003 Feb;30(2):256-9.

  PMID: 12563677 BACKGROUND

• Kinross P, Suetens C, Dias JG, Alexakis L, Wijermans A, Colzani E, Monnet DL; European Centre for Disease Prevention and Control (ECDC) Public Health Emergency Team; ECDC Public Health Emergency Team. Rapidly increasing cumulative incidence of coronavirus disease (COVID-19) in the European Union/European Economic Area and the United Kingdom, 1 January to 15 March 2020. Euro Surveill. 2020 Mar;25(11):2000285. doi: 10.2807/1560-7917.ES.2020.25.11.2000285. Epub 2020 Mar 16.

  PMID: 32186277 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

collagen-PVP; pirfenidone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hugo Mendieta Zerón, PhD

  Mónica Pretelini Sáenz Maternal Perinatal Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Patients were assigned one of the following treatments: pirfenidone (KitosCell tabs, CellPharma S de RL de CV. Mexico City, Mexico) 1,200 mg of oral q12 h or collagen-PVP (Fibroquel, Aspid SA de CV, Mexico City, Mexico) 2 ml intramuscular q24 h, for 7 days; control group was of patients without pirfenidone or collagen-PVP. Body temperature, heart rate, respiratory rate, pSO2%, PCO2, and pO2, hematic biometry, serum concentrations of glucose, uric acid, cholesterol, and triacyl glycerides, IFN-γ, TNF-α, IL-2, -4, -10, -13 and -17 were measured at the beginning and after 7 days of treatment.

Study Record Dates

• First Submitted: September 1, 2024
• First Posted: September 5, 2024
• Study Start: February 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: August 31, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)