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COMPLETEDPHASE3

Open Multicentre Study of the Safety and Efficacy Against COVID-19 of Nirmatrelvir/Ritonavir in the Adult Population

Open Multicentre Study for Assessment of the Safety and Efficacy Against COVID-19 of the Drug JTBC00201 (PROMOMED RUS LLC, Russia) in the Adult Population

NCT05601167•Promomed, LLC

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Availability of PIS Informed Consent Form signed and dated by a patient.
•Male and female subjects aged 18 to 80 inclusive as of the time of signing the PIS Informed Consent Form.
•Confirmed COVID-19 at screening stage: positive for SARS-CoV-2 RNA laboratory test with nucleic acid amplification techniques (NAAT) or SARS-CoV-2 antigen with immunochromatographic assay.
•SARS-CoV-2 test results obtained up to 5 days prior to randomization may be taken into account upon availability of supporting documentation.
•Mild or moderate SARS-CoV-2 induced infection.
•At least one of the following COVID-19 symptoms as of the time of screening and randomization: nasal congestion or rhinitis; sore throat; dyspnoea or respiratory distress on exertion; cough; tiredness; pain in muscles or throughout the body; headache; chills; fever (body temperature \> 38 ⁰С); nausea; vomiting; diarrhoea; anosmia; ageusia.
•Disease onset (first symptom) within not more than 5 days prior to randomization
•The patient agrees and is able to take oral drug products.
•Patient's consent to use reliable contraception methods during the entire study and for 3 weeks after the end of the study. Reliable contraception methods are: sexual abstinence, the use of a condom combined with a spermicidal agent.
•Female subjects incapable of bearing children (history: hysterectomy, tubal ligation, infertility, menopause for more than 2 years), as well as male subjects with infertility or a history of vasectomy may participate in the study.

Exclusion Criteria

•Hypersensitivity to the study drug components.
•Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
•Use of direct-acting antiviral drugs within 10 days prior to screening.
•The use of drugs at the time of screening whose clearance is highly dependent on the CYP3A isoenzyme, or which are strong inducers of CYP3A (for more information, see the section "Unauthorized pharmaceuticals").
•Necessity to use unauthorized pharmaceuticals.
•The need for oxygen therapy at the time of screening.
•Hospitalization required at time of screening, or hospitalization expected to be required for COVID-19 within 48 hours of randomization, excluding hospitalization to the observation facility for social reasons (e. g., living in a hostel, cohabiting with people, including those with risk factors for aggravated COVID-19, who, after contact with the patient, have a negative result for the SARS-CoV-2 RNA/antigen, etc.).
•Severe and extremely severe disease signs as of the time of screening.
•Vaccination within less than 4 weeks prior to screening.
•Possible or confirmed moderate COVID-19 within 6 months prior to screening.
+11 more criteria

Locations (11)

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

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

Key Dates

Start Date

February 17, 2021

Primary Completion Date

June 1, 2022

Completion Date

June 1, 2022

Last Updated

April 10, 2023

Enrollment

264

ACTUAL participants

Conditions

COVID-19

Interventions

nirmatrelvir/ritonavir

DRUG

Standard of care

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Open Multicentre Study of the Safety and Efficacy Against COVID-19 of Nirmatrelvir/Ritonavir in the Adult Population

Inclusion Criteria

Exclusion Criteria

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