This is open-labe randomized multicenter comparative Phase III study conducted in 8 medical facilities. The objective of the study is to assess the efficacy, safety and tolerability of Ambervin for intramuscular and inhaled administration in complex therapy COVID-19 compared with the Standard of care (SOC) in hospitalized patients with moderate COVID-19.
Upon signing the informed consent form and screening, 313 eligible patients hospitalized with COVID-19 were randomized at a 1:1:1 ratio to receive either Ambervin intramuscular 1mg 1 times a day for 10 days or Ambervin inhaled 10mg 1 times a day for 10 days or SOC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
313
lyophilizate for preparation of solution for intramuscular administration 1 mg 1 time per day for 10 days
lyophilizate for preparation of solution for inhalation administration 10 mg 1 time per day for 10 days
The administration of 'StandardTherapy' drugs was done according to the regimen recommended in the 'COVID-19TreatmentGuidelines'(current version)
Budgetary institution of the Chuvash Republic "Emergency Hospital"
Cheboksary, Russia
City clinical Hospital №24
Moscow, Russia
Infectious Clinical Hospital No.1
Moscow, Russia
Prevalence of patients with category 0-1 as per categorical ordinal clinical improvement WHO scale
The proportion of patients with category 0-1 as per the categorical ordinal clinical improvement scale
Time frame: From baseline to Visit 4 (days 14-15)
Prevalence of patients with clinical status less than 4 points on the categorical ordinal WHO scale of clinical improvement
The proportion of patients with clinical status less than 4 points on the categorical ordinal WHO scale of clinical improvement
Time frame: From baseline to Visit 3 (days 11-12) and 4 (days 14-15)
Frequency of improvement in clinical status on a categorical ordinal WHO scale of clinical improvement of 2 or more categories
The proportion of patients with clinical status on a categorical ordinal WHO scale of clinical improvement of 2 or more categories
Time frame: From baseline to Visit 3 (days 11-12) and 4 (days 14-15)
Time to improve clinical status on a categorical ordinal scale of clinical improvement by ≥ 1 point.
Number of days to improve clinical status on a categorical ordinal scale of clinical improvement by ≥ 1 point.
Time frame: From baseline to Visit 6 (study completion, day 28±1)
Prevalence of patients eligible for discharge to continue outpatient treatment according to BMR
The proportion of patients eligible for discharge to continue outpatient treatment according to current Cuidelines
Time frame: From baseline to Visit 2 (days 6-7), 3 (days 11-12)
Prevalence of patients with RR < 22/min
The proportion of patients with RR \< 22/min
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State Budgetary Healthcare Institution City Clinical Hospital named after S. I. Spasokukotskiy of Moscow Healthcare Department
Moscow, Russia
Regional Clinical Hospital
Ryazan, Russia
Ryazan State Medical University named after academician I.P. Pavlov of Ministry of Health of the Russian Federation
Ryazan, Russia
Ogarev Mordova State University of Ministry of Health of the Russian Federation
Saransk, Russia
City Hospital No. 40 Kurortny District
Sestroretsk, Russia
Regional State Budget Healthcare Institution "Clinical hospital No. 1"
Smolensk, Russia
Voronezh Regional Clinical Hospital No.1
Voronezh, Russia
Time frame: From baseline to Visit 2 (days 6-7), 3 (days 11-12)
Prevalence of patients with CRP level < 10 mg/l
The proportion of patients with CRP level \< 10 mg/l
Time frame: From baseline to Visit 2 (days 6-7), 3 (days 11-12)
Prevalence of patients with blood lymphocytes > 1.2 x 10(9)/L
The proportion of patients with blood lymphocytes \> 1.2 x 10(9)/L
Time frame: From baseline to Visit 2 (days 6-7), 3 (days 11-12)
Assessment of the degree of lung damage according to CT
The degree of lung damage according to CT
Time frame: From baseline to Visit 4 (days 14-15)
Prevalence of patients with SpO2 ≥ 95% on 2 consecutive days
The proportion of patients with SpO2 ≥ 95% on 2 consecutive days
Time frame: From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)
The frequency of transfer of patients to the intensive care unit and intensive care
The proportion of patients transferred to the intensive care unit and intensive care
Time frame: From baseline to Visit 6 (study completion, day 28±1)
The frequency of cases of the use of high flow oxygen therapy, non-invasive and invasive ventilation of lung, ECMO
The proportion of patients who used high flow oxygen therapy, non-invasive and invasive ventilation of lung, ECMO
Time frame: From baseline to Visit 6 (study completion, day 28±1)
The frequency of cases of ARDS
The proportion of patients with ARDS
Time frame: From baseline to Visit 6 (study completion, day 28±1)
The frequency of patients with a fatal outcome
The proportion of patients with a fatal outcome
Time frame: From baseline to Visit 6 (study completion, day 28±1)