COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=51118

Qun Luo

luoqunx@163.com

2020-03-16

Recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

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).

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).

2

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

18

80

China

Severe disease at enrollment

6: Severe disease at enrollment

40

HRCT pulmonary fibrosis score;

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 0

[{"arm_notes": "", "treatment_id": 995, "treatment_name": "Pirfenidone", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]