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Completed

NCT Number: NCT05713292

Pirfenidone in Adult Hospitalized Patients With COVID-19

This center intends to conduct a multicenter, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe COVID-19.

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Key information

Conditions

COVID-19 Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects Age ≥ 18 Willing and able to provide written informed consent
  • SARS-CoV-2 infection confirmed by PCR test/antigen dectection or positive serologies
  • Time of illness onset ≥8 days
  • Have findings consistent with interstitial lung disease found on CT scan
  • Willing not use other investigational agents of anti-fibrosis

Exclusion criteria

  • Pre-existing severe liver disease
  • Pre-existing severe chronic kidney disease
  • Pre-existing interstitial lung disease
  • Pre-existing severe COPD or other structural lung disease
  • Receiving invasive mechanical ventilation
  • Currently Pregnant or Breast Feeding
  • Poor baseline health conditoin
  • Disability to complete lung function test
  • Receiving pirfenidone wthin half-year

Treatment and study plan

Pirfenidone Oral Product

Drug

Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months

Pirfenidone placebo

Drug

Pirfenidone placebo

Primary outcomes

  1. To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection

    Time frame: 1 month

    • Change of total lung lesion volume on Chest CT from enrollment to 1 month follow up
    • DLCO% pred at 1 month follow up

Secondary outcomes

  1. distance walked in 6 Minutes (6MWD)

    Time frame: at the 1 month and 3 months follow-up vist

    the difference between intervention group and placebo group

  2. the EuroQol five-dimension five-level (EQ-5D-5L)

    Time frame: at the 1 month and 3 months follow-up vist

    the difference between intervention group and placebo group

  3. Medical Research Council (mMRC) dyspnoea scale

    Time frame: at the 1 month and 3 months follow-up vist

    the difference of mMRC score between intervention group and placebo group

  4. difference of forced vital capacity (FVC) between two groups

    Time frame: at the 1 month and 3 months follow-up vist

    the difference of actual and predicted value between intervention group and placebo group

  5. difference of total lung capacity (TLC) between two groups

    Time frame: at the 1 month and 3 months follow-up vist

    the difference of actual and predicted value between intervention group and placebo group

  6. difference of DLCO between two groups

    Time frame: at the 3 months follow-up vist

    the difference of actual and predicted value between intervention group and placebo group

  7. incidence of adverse event

    Time frame: within 2 months after enrollment

    the difference of adverse event frequency between intervention group and placebo group

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pirfenidone in Adult Hospitalized Patients With COVID-19.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2023
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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