SE OF INHALATORY APROTININE AS AN ANTIVIRAL FOR TREATMENT OF SARS-CoV-2 (COVID-19) IN HOSPITALIZED PATIENTS.
- Conditions
- Patients with moderate SARS-CoV-2 pneumonia confirmed with adiagnosis of polymerase chain reaction (PCR) before randomization. Thepatient should be hospitalized and require ongoing medical care forSARS-CoV-2. With peripheral capillary O2 saturation levels (SpO2 ) >90% breathing ambient air. With radiographic evidence of pulmonaryinfiltrates.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
- Registration Number
- EUCTR2020-002434-33-ES
- Lead Sponsor
- Hospital General Universitario Ciudad Real
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 105
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Reduce the number of admissions to the Intensive Care Unit taking into<br>account the ATS/IDSA criteria in the intervention group with respect to<br>the control group.;Secondary Objective: os:<br>English - To improve clinical parameters in the successive days of follow-up in<br>the intervention group.<br>- To improve analytical parameters (hemogram, coagulation, and<br>biochemical) in the successive days of follow-up in the intervention<br>group.<br>- To compare the SOFA Scale (respiratory complications, coagulation,<br>liver, central nervous system alterations) in both groups on admission to<br>the Intensive Care Unit.<br>- Compare hospital stay, ICU stay and mortality in both groups.<br>- Compare FEV 1 of patients in both groups after discharge from hospital.<br>- 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 Outcome Measures
Name Time Method Secondary end point(s): Admission;Timepoint(s) of evaluation of this end point: Mortalidad