Efficacy and Safety of Pirfenidone in the Treatment of Severe Post-Novel Coronavirus Pneumonia (COVID-19) Fibrosis: a prospective exploratory experimental medical study

Efficacy and Safety of Pirfenidone in the Treatment of Severe Post-Novel Coronavirus Pneumonia (COVID-19)) Fibrosis:a prospective exploratory experimental medical study

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000030892

Enrollment

Unknown

Registered

2020-03-16

Start date

2020-03-06

Completion date

Unknown

Last updated

2020-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrosis after Severe Coronavirus Disease 2019 (COVID-19) Pneumonia

Interventions

Experimental group:Pirfenidone

Control group:Blank

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged from 18 to 80 years; 2. conformed to epidemic history; 3. fever and respiratory symptoms; 4. normal or decreased leukocyte count in peripheral blood; or decreased lymphocyte count; 5. conformed to imaging features of COVID-19 pneumonia; 6. positive for COVID-19 nucleic acid test or second-generation sequencing of pathogens; 7. serum KL- 61500U / ml; 8. and conforms to any of the following: (1) respiratory distress, RR >=30 beats / min; (2) oxygen saturation <=93% at rest; (3) partial pressure of arterial oxygen (PaO2) / oxygen concentration (FiO2) <=300mmHg (1mmHg=0.133kPa).

Exclusion criteria

Exclusion criteria: 1. people who are allergic to pifenidone capsules; 2. the researchers judged that the compliance of the subjects was not good; 3. those who cannot take drugs through gastrointestinal tract; 4. any significant clinical or laboratory abnormalities that may affect the safety assessment, such as: serum creatinine > 2mg/dL or 176.8mmol sputum alt, AST >=2.5 ULN or TBIL >=1.5 ULN; 5. patients with severe liver disease; 6. pregnant and lactating patients; 7. patients with severe nephropathy or requiring dialysis treatment; 8. those who need to take fluvoxamine at the same time (a drug for the treatment of depression or obsessive-compulsive disorder).

Design outcomes

Primary

Measure	Time frame
HRCT pulmonary fibrosis score;	—

Countries

China

Contacts

Public ContactQun Luo

State Key Laboratory of Respiratory Disease, National Clinical Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University

luoqunx@163.com+86 13710658121

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026