Patients with moderate SARS-CoV-2 pneumonia confirmed with a diagnosis of polymerase chain reaction (PCR) before randomization. The patient should be hospitalized and require ongoing medical care for SARS-CoV-2. With peripheral capillary O2 saturation levels (SpO2 ) > 90% breathing ambient air. With radiographic evidence of pulmonary infiltrates.
Conditions
Interventions
Trade Name: Aprotinine
Product Name: Trasylol
Product Code: B02AB01
Pharmaceutical Form: Inhalation vapour
Sponsors
Hospital General Universitario Ciudad Real
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients 18 years and older, either sex. Healthy volunteers are not allowed. Patients with moderate SARS-CoV-2 pneumonia confirmed with a diagnosis of polymerase chain reaction (PCR) before randomization. The patient should be hospitalized and require ongoing medical care for SARS-CoV-2. With peripheral capillary O2 saturation levels (SpO2 ) > 90% breathing ambient air. With radiographic evidence of pulmonary infiltrates Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Those patients who do not present the signed documents, or whose informed consent is not obtained at a date prior to the completion of the study or any specific intervention in it. Patients who have had a previous exposure to aprotinin in the last 6 months or with a known suspected allergy to aprotinin or high levels of antiprotinin IgG. Patients with a history of bleeding diathesis, deep vein thrombosis or pulmonary embolism or known clotting factor deficiency Based on the researcher's opinion on any medically significant active disease the patient may have. Patients who refuse to receive allogeneic blood products Patients with low red blood cell volume with blood transfusion needs (preoperative hematocrit of < 24% or hemoglobin of < 8 g / dl). Patients with a history of allergic asthma or lung atopy reactions or COPD. Patients with sepsis. Participation in any other clinical trial of an experimental treatment for SARS-CoV-2 or any other clinical trial in the last 30 days. Concurrent treatment with other agents with antiviral action actual or potential direct SARS-CoV-2 exposure < 24 hours prior to dosing of the study drug. Require mechanical ventilation at screening. Subjects with poor renal function (serum creatinine <2.5 mg/dL or 221 µM). Pregnant or breastfeeding women or women of childbearing age in whom The possibility of pregnancy cannot be excluded by a pregnancy test negative and that they are not using a reliable method of contraception. Administration of other antifibrinolytic drugs (e.g., acid aminocaproic or tranexamic acid), or those patients undergoing chronic anticoagulant with acenocoumarol or warfarin that cannot be stopped temporarily the treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reduce the number of admissions to the Intensive Care Unit taking into account the ATS/IDSA criteria in the intervention group with respect to the control group.;Secondary Objective: os: English - To improve clinical parameters in the successive days of follow-up in the intervention group. - To improve analytical parameters (hemogram, coagulation, and biochemical) in the successive days of follow-up in the intervention group. - To compare the SOFA Scale (respiratory complications, coagulation, liver, central nervous system alterations) in both groups on admission to the Intensive Care Unit. - Compare hospital stay, ICU stay and mortality in both groups. - Compare FEV 1 of patients in both groups after discharge from hospital. - Determine the possible adverse reactions of aprotinin administered by inhalation.;Primary end point(s): Ingreso en UCI;Timepoint(s) of evaluation of this end point: Mortalidad | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Admission;Timepoint(s) of evaluation of this end point: Mortalidad | — |
Countries
Spain
Contacts
Public ContactCoordinador IDFCyB
Hospital General Universitario Ciudad Real
Outcome results
None listed