COVID 19Phase 2/3NCT06585319
Pirfenidone LP or Collagen-polyvinylpyrrolidone in COVID-19
A Phase 2/3 study testing Collagen-polyvinylpyrrolidone and Pirfenidone 1200 mg in people with COVID 19, run by Materno-Perinatal Hospital of the State of Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID 19
- What is being tested?
- Collagen-polyvinylpyrrolidone and Pirfenidone 1200 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteMexico
- Study dates
- 1 Feb 2020to 31 Aug 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients infected with SARS-CoV-2, hospitalized, with total bilirubin ≤1.5
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Monica Pretelini Saenz Maternal Perinatal Hospital
Toluca, State of Mexico, 50120
About this study
Official title: Pilot Study of Kitoscell LP (pirfenidone LP) Vs Collagen-polyvinylpyrrolidone As Treatment and Protection in Patients with Moderate to Severe COVID-19
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.
Read the detailed description
The therapeutic target of COVID-19 is focused on the control of inflammation and the prevention of fibrosis. Collagen-polyvinylpyrrolidone (collagen-PVP) and pirfenidone have the ability to control cytokine storms observed in rheumatic and fibrotic disorders. In this work, the investigators explored the therapeutic effects of both, in addition to dexamethasone, 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. Furthermore, only collagen-PVP normalized serum glucose at discharge. Since the intracellular mechanism of action of pirfenidone is partially known, it was performed a whole human genome microarray assay with total RNA isolated from fibroblast and macrophage cultures treated with collagen-PVP. Ingenuity Pathway Analysis showed that cell cycle, inflammation, and cell surface-extracellular matrix interaction could be regulated by the collagen-PVP copolymer, by down-regulation of pro-inflammatory cytokines, such as IL-6 and -8, while Th2 anti-inflammatory response signaling could be up-regulated. Additionally, down-regulation of some of the genes involved in nitric oxide production by inducible nitric oxide synthase showed a possible control for JAK, in the IFN-γ pathway, allowing the possibility of controlling inflammation through the JAK/STAT pathway, as has been observed for pirfenidone and other immunomodulators, such as ruxolitinib. In summary, once again, collagen-PVP and pirfenidone have demonstrated to favor inflammatory control and stand out as a possible therapy for inflammatory disorders derived from viral or microorganism infections.
- Conditions
- COVID 19
- Being tested
- Collagen-polyvinylpyrrolidone, Pirfenidone 1200 mg
- Keywords
- collagen-polyvinylpyrrolidone, pirfenidone, survival, immunomodulation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen-polyvinylpyrrolidoneDrug
2 ml intramuscular q24 h
Pirfenidone 1200 mgDrug
1,200 mg of oral q12 h
| Study group | Role | What they receive |
|---|---|---|
| Collagen-polyvinylpyrrolidone | Experimental | Collagen-PVP ml intramuscular q24 h Receives: Drug: Collagen-polyvinylpyrrolidone |
| Pirfenidone | Active comparator | Pirfenidone 1,200 mg of oral q12 h Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment until one month of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start1 Feb 2020
- Primary completion30 Jun 2021
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materno-Perinatal Hospital of the State of Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico
- Investigators
- Hugo Mendieta Zerón, PhD, Principal investigator, Mónica Pretelini Sáenz Maternal Perinatal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585319
- Sponsor's protocol ID
- 2020-12-713
- Status last verified
- Sep 2024
- First submitted
- 1 Sep 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because patients were treated in COVID Hospitals with restricted access, information could only be shared through a request from institution to institution with a detailed explanation of the reason for the consultation.
Publications
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.
PubMed 25051159Olmos-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.
PubMed 28584818Furuzawa-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.
PubMed 12563677Kinross 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.
PubMed 32186277
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Kitoscell LP (pirfenidone LP) Vs Collagen-polyvinylpyrrolidone As Treatment and Protection in Patients with Moderate to Severe COVID-19
- ClinicalTrials.gov ID
- NCT06585319
- Acronym / sponsor ID
- 2020-12-713
- Conditions
- COVID 19
- Keywords
- collagen-polyvinylpyrrolidone, pirfenidone, survival, immunomodulation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Materno-Perinatal Hospital of the State of MexicoUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The therapeutic target of COVID-19 is focused on the control of inflammation and the prevention of fibrosis. Collagen-polyvinylpyrrolidone (collagen-PVP) and pirfenidone have the ability to control cytokine storms observed in rheumatic and fibrotic disorders. In this work, the investigators explored the therapeutic effects of both, in addition to dexamethasone, 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. Furthermore, only collagen-PVP normalized serum glucose at discharge. Since the intracellular mechanism of action of pirfenidone is partially known, it was performed a whole human genome microarray assay with total RNA isolated from fibroblast and macrophage cultures treated with collagen-PVP. Ingenuity Pathway Analysis showed that cell cycle, inflammation, and cell surface-extracellular matrix interaction could be regulated by the collagen-PVP copolymer, by down-regulation of pro-inflammatory cytokines, such as IL-6 and -8, while Th2 anti-inflammatory response signaling could be up-regulated. Additionally, down-regulation of some of the genes involved in nitric oxide production by inducible nitric oxide synthase showed a possible control for JAK, in the IFN-γ pathway, allowing the possibility of controlling inflammation through the JAK/STAT pathway, as has been observed for pirfenidone and other immunomodulators, such as ruxolitinib. In summary, once again, collagen-PVP and pirfenidone have demonstrated to favor inflammatory control and stand out as a possible therapy for inflammatory disorders derived from viral or microorganism infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Collagen-polyvinylpyrrolidone | Experimental | Drug: Collagen-polyvinylpyrrolidoneCollagen-PVP ml intramuscular q24 h |
| Pirfenidone | Active comparator | Drug: Pirfenidone 1200 mgPirfenidone 1,200 mg of oral q12 h |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients infected with SARS-CoV-2, hospitalized, with total bilirubin ≤1.5
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagen-polyvinylpyrrolidone2 ml intramuscular q24 h | Drug | Collagen-polyvinylpyrrolidone |
| Pirfenidone 1200 mg1,200 mg of oral q12 h | Drug | Pirfenidone |
Primary outcome
Number of patients that survived the COVID-19 infection
Time frame: From enrollment until one month of follow up
After each of the treatments that were given for seven days, the evolution of the patients was recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Background: PubMed 25051159Leyva-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.
- Background: PubMed 28584818Olmos-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.
- Background: PubMed 12563677Furuzawa-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.
- Background: PubMed 32186277Kinross 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.
- Individual participant dataSharing planned: No. Because patients were treated in COVID Hospitals with restricted access, information could only be shared through a request from institution to institution with a detailed explanation of the reason for the consultation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugo Mendieta Zerón, PhD principal investigator
Mónica Pretelini Sáenz Maternal Perinatal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Collagen-polyvinylpyrrolidone and Pirfenidone 1200 mg in people with COVID 19, run by Materno-Perinatal Hospital of the State of Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that survived the COVID-19 infection (time frame: From enrollment until one month of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06585319, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.