EUCTR2020-002434-33-ES
Active, not recruiting
Phase 1
Phase 3 randomized study to evaluate the safety and efficacy of aprotinin (Trasylol®) administered by inhalation nebulization in patients diagnosed with SARS-CoV-2 (COVID-19) with moderate severity compared to standard therapy. - EFFICACY OF APROTININE IN COVID-19.
Hospital General Universitario Ciudad Real0 sites105 target enrollmentFebruary 24, 2022
ConditionsPatients 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]
DrugsAprotinine
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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.
- Sponsor
- Hospital General Universitario Ciudad Real
- Enrollment
- 105
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients 18 years and older, either sex. Healthy volunteers are not
- •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
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.
Outcomes
Primary Outcomes
Not specified
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