Efficacy and Safety of ulinastatin in the Treatment of novel coronavirus pneumonia (COVID-19)

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2020
INTERVENTION: Experimental group: mild cases:Ulinastatin 300,000 IU, Q12H;Experimental group: severe or critical cases:Severe cases: 1 million IU of ulinastatin, Q8H; Critical cases: ulinastatin 1.6 million IU, Q8H;Control group: mild cases:conventional therapy;Control group: severe or critical cases :conventional therapy; CONDITION: Novel Coronavirus Pneumonia (COVID‐19) PRIMARY OUTCOME: mild cases: the critical illness rate of subjects at weeks 2;Severe or critical cases: the Changes of PaO2/FiO2 from baseline to day 1, 3, 5 and 24 hours later after the last administration;Safety data of COVID‐19 patients treated with ulinastatin were collected; SECONDARY OUTCOME: Lung CT imaging findings;Peripheral blood CD4+ cell count;blood lactic acid;oxygen saturation;The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3, 5, 7; INCLUSION CRITERIA: 1) Aged 18 to 75 years old, male or female; 2) The confirmed participants were diagnosed as mild, severe or critical cases according to the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 7); 3) Those who agree not to participate in other clinical studies within 30 days after administration of the study; 4) Patients voluntarily signed informed consent.
Epistemonikos ID: 6581bccf3a0f4345074c19ca5b8cc9647d1d0ed5
First added on: Apr 30, 2020