This is open-labe randomized multicenter comparative Phase III study conducted in 12 medical facilities. The objective of the study is to evaluate efficacy and safety of the drug JCBC00101, capsules 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, 240 eligible outpatients with mild or moderate COVID-19 were randomized at a 1:1 ratio to receive either molnupiravir capsules, 800 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
240
Capsules 800 mg, 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'(Version 14 of 27.12.2021), or inforce at the time of the study
Regional Budget 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 Current clinical Guidelines, version 14 (December 27,2021).
Time frame: From baseline to Visit 4 (days 14-15)
Clinical status changes as per the categorical ordinal clinical improvement WHO scale
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 as per the categorical ordinal clinical improvement WHO scale by ≥ 1 category
The proportion of patients with clinical status deterioration as per the categorical ordinal clinical improvement scale of ≥ 1 category
Time frame: From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)
Prevalence of patients with category 0 as per categorical ordinal clinical improvement WHO scale
The proportion of patients with category 0 as per the categorical ordinal clinical improvement scale
Time frame: From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)
Prevalence of patients with category 1 and less according to clinical improvement WHO scale
The proportion of patients with category 1 and less as per the categorical ordinal clinical improvement 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Moscow, Russia
Professorskaya klinika, LLC
Perm, 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 Budget Healthcare Institution "Clinical hospital No. 1"
Smolensk, Russia
Smolensk State Medical University of Ministry of Health of the Russian Federation
Smolensk, Russia
...and 2 more locations
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 Major Symptom Rating Scale.
The proportion of patients with Symptoms intensity score as per COVID-19 Major Symptom Rating 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)