This is open-labe randomized multicenter comparative Phase III study conducted in 11 medical facilities. The objective of the study is to evaluate efficacy and safety of the drug JTBC00201, tablets in the setting of pathogenetic and symptomatic therapy as compared to standard therapy in outpatients with COVID-19.
Upon signing the informed consent form and screening, 264 eligible outpatients with mild or moderate COVID-19 were randomized at a 1:1 ratio to receive either nirmatrelvir/ritonavir tablets, 300/100 mg, 2 times a day with 12 ±2 hours interval for 5 days, or SOC
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
264
Tablets 300/100mg, 2 times a day with 12 ±2 hours interval for 5 days
The administration of 'Standard of care' drugs was done according to the regimen recommended in the 'COVID-19 TreatmentGuidelines' validated at the time of the study
Regional Budgetary Healthcare Institution "Ivanovo Clinical Hospital"
Ivanovo, Russia
Kirov State Medical University of Ministry of Health of the Russian Federation
Kirov, Russia
State Budgetary Healthcare Institution City Clinical Hospital named after S. I. Spasokukotskiy of Moscow Healthcare Department
Prevalence of patients with COVID-19 severity increase as compared from baseline to Visit 4
Patient severity score at screening and during treatment was determined as per сurrent clinical Guidelines
Time frame: From baseline to Visit 4 (days 14-15)
Clinical status changes according to the WHO Ordinal Scale ranges from 0 (uninfected) to 8 (dead)
The score as per the categorical ordinal clinical improvement WHO scale
Time frame: From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15), 5 (days 21±1), 6 (study completion, day 28±1)
Clinical status deterioration incidence according to the WHO Ordinal Scale ranges from 0 (uninfected) to 8 (dead) by ≥ 1 category
The proportion of patients with clinical status deterioration as per the categorical ordinal clinical improvement on the WHO scale of ≥1 category
Time frame: From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)
Achievement of clinical status 0 according to the WHO Ordinal Scale ranges from 0 (uninfected) to 8 (dead)
The proportion of patients with category 0 as per the categorical ordinal clinical improvement on the WHO scale
Time frame: From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)
Prevalence of patients with negative SARS-CoV-2 RNA test
The proportion of patients with negative SARS-CoV-2 RNA test
Time frame: From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)
Symptoms intensity score as per COVID-19 Related Symptom Scale
The proportion of patients with Symptoms intensity score as per COVID-19 Major Symptom Rating Scale. Ranges for each symptom: 0 points (no symptoms) - 3 points (severe)
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Moscow, Russia
Regional Clinic Hospital of Ryazan
Ryazan, Russia
Ryazan State Medical University named after academician I.P. Pavlov of Ministry of Health of the Russian Federation
Ryazan, Russia
Avrora MedFort, LLC
Saint Petersburg, Russia
OrCli Hospital, LLC
Saint Petersburg, Russia
Ogarev Mordova State University of Ministry of Health of the Russian Federation
Saransk, Russia
Regional State Budgetary Healthcare Institution "Clinical Hospital No. 1"
Smolensk, Russia
Smolensk State Medical University of Ministry of Health of the Russian Federation
Smolensk, Russia
...and 1 more locations
Time frame: From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15), 5 (days 21±1), 6 (study completion, day 28±1)