Status:
UNKNOWN
An Open Non-comparative Study of the Efficacy and Safety of Aprotinin in Patients Hospitalized With COVID-19
Lead Sponsor:
Aviron LLC
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The observational study will be carried out in two stages. At the first stage, the efficacy and safety of Aprotinin intravenous infusion as add-on therapy to the standard of care will be studied. At t...
Detailed Description
Primary objective of the study is to evaluate the efficacy of Aprotinin as add-on therapy in patients hospitalized with COVID-19 using the following parameters: * The time to elimination of SARS-CoV-...
Eligibility Criteria
Inclusion
- Signed Patient Information Sheet and Informed Consent Form for participation in the study;
- Adult male or female ≥18 years of age;
- Body mass \< 90 kg;
- Positive qualitative RNA SARS-CoV-2 PCR analysis at screening;
- Score 4 on the WHO-OSCI (added at Stage 2);
- Subjects with moderate-to-severe disease with the follow conditions and symptoms:
- Pneumonia;
- Fever \> 38°C;
- Blood serum CRP \> 10 mg/L.
- Agreement to use medically acceptable forms of birth control during the study (contraceptive with spermicide).
Exclusion
- Severe disease with one of the follow criteria:
- Respiratory rate \> 35 per minute that doesn't decrease after body temperature reducing to normal or subfebrile level;
- Saturation ≤ 93% at rest;
- Partial pressure of arterial oxygen (PaO2) \< 60 mmHg;
- Oxygenation index (РаО2/FiO2) ≤ 200 mmHg;
- Partial pressure of arterial CO2 (PaCO2) \> 60 mmHg;
- Septic shock.
- Chronic liver and kidney diseases in terminal stage;
- Other organs failure requiring control and treatment in the ICU;
- Subjects with HIV;
- Using of Aprotinin during 6 months prior to screening; hypersensitivity to any of the drug components;
- Participation in any other clinical trial or using of other study drugs during 28 days prior to screening;
- Pregnant or lactating women or women planning pregnancy during the clinical study; women with child-bearing potential (including women non-sterilized surgically and in postmenopause for less than 2 years) not using medically acceptable forms of birth control;
- Inability to read or write; unwillingness to understand and follow the Protocol procedures; non-compliance with the regimen of taking medications or performing procedures that, according to the Investigator, may affect the results of the study or the safety of the patient and prevent the patient from further participation in the study; any other comorbid medical or serious mental conditions that make patient ineligible for participation in the clinical study, limits the ability to obtain informed consent, or may affect patient's ability to participate in the study.
Key Trial Info
Start Date :
June 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04527133
Start Date
June 11 2020
End Date
August 31 2020
Last Update
August 26 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Regional State Budgetary Healthcare Institution "Clinical Hospital №1"
Smolensk, Russia