COVID-19 Clinical Trial
Official title:
An Open Non-comparative Study of the Efficacy and Safety of Aprotinin in Patients Hospitalized With COVID-19
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 the second stage, two groups will be included: the first group will be the inhaled Aprotinin add-on therapy, the second group will be intravenous Aprotinin in combination with Favipiravir.
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-2 virus until Day 10;
- The time to C-reactive protein (CRP) normalization until Day 10;
- The time to D-dimer normalization until Day 10.
Secondary objectives are to evaluate the following parameters of efficacy and safety of
Aprotinin add-on therapy in patients hospitalized with COVID-19:
- The time to body temperature normalization (<37oC);
- Changes from baseline of the laboratory parameters during 14 days: hematology, CRP,
coagulogram;
- Changes of lung injury on CT scan on Day 7 and Day 14 from baseline;
- Frequency of clinical status improvement by 2 scores in accordance with the WHO Ordinal
scale of clinical improvement (WHO-OSCI) or discharge from the hospital before Day 14;
- Frequency of transfer to the Intensive Care Unit (ICU), frequency of the non-invasive
ventilation, frequency of the invasive ventilation and mortality rate;
- Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) of various severity
according to subjective complains, physical examination, vital signs, laboratory tests
and ECG.
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