- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05601167
Open Multicentre Study of the Safety and Efficacy Against COVID-19 of Nirmatrelvir/Ritonavir in the Adult Population
April 6, 2023 updated by: Promomed, LLC
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
264
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ivanovo, Russian Federation
- Regional Budgetary Healthcare Institution "Ivanovo Clinical Hospital"
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Kirov, Russian Federation
- Kirov State Medical University of Ministry of Health of the Russian Federation
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Moscow, Russian Federation
- State Budgetary Healthcare Institution City Clinical Hospital named after S. I. Spasokukotskiy of Moscow Healthcare Department
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Ryazan', Russian Federation
- Regional Clinic Hospital of Ryazan
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Ryazan', Russian Federation
- Ryazan State Medical University named after academician I.P. Pavlov of Ministry of Health of the Russian Federation
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Saint Petersburg, Russian Federation
- Avrora MedFort, LLC
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Saint Petersburg, Russian Federation
- OrCli Hospital, LLC
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Saransk, Russian Federation
- Ogarev Mordova State University of Ministry of Health of the Russian Federation
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Smolensk, Russian Federation
- Regional State budgetary healthcare institution "Clinical Hospital No. 1"
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Smolensk, Russian Federation
- Smolensk State Medical University of Ministry of Health of the Russian Federation
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Yaroslavl, Russian Federation
- State Budgetary Healthcare Institution of the Yaroslavl Oblast "Clinical Hospital No.3"
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
- Possible or confirmed history of severe or very severe COVID-19.
- Patients with moderate to severe renal insufficiency (estimated glomerular filtration rate (GFR) < 60 ml/min/1.73 m2 per CKD-EPI formula) or receiving renal replacement therapy at the time of screening.
- Severe liver failure (class C per Child-Pugh) at the time of screening or elevated ALT and/or AST levels of ≥ 2.5 UNL and/or elevated total bilirubin levels of ≥ 2 UNL (≥ 3 UNL with Gilbert's syndrome) in past medical history (within 6 months prior to screening).
- Positive test result for HIV, syphilis, hepatitis B and/or C at the time of screening.
- Alcohol, pharmacological and/or drug dependence (history and/or at the time of screening).
- Schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric disorder (history or suspected) at the time of screening.
- Any history data that may complicate, in the opinion of the investigator, interpretation of the study results or create additional risk for the patient due to his/her participation in the study.
- Unwillingness or inability of a patient to comply with the Protocol procedures (in the opinion of the investigator).
- Pregnant or lactating women, or women planning a pregnancy.
- Participation in another clinical study within 3 months prior to enrolment in the present study.
- Other conditions that prevent the patient from inclusion in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: JTBC00201 (nirmatrelvir/ritonavir, Skayvira)
Group 1 (n=132) received the study drug nirmatrelvir/ritonavir, tablets 300/100 mg, 2 times a day with 12 ±2 hours interval for 5 days in the setting of pathogenetic and symptomatic therapy provided by Interim Guidelines for the prevention, diagnosis and treatment of COVID-19 validated of the time of the study
|
Tablets 300/100mg, 2 times a day with 12 ±2 hours interval for 5 days
Other Names:
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Active Comparator: Standard of care
Group 2 (n=132) patients receive standard therapy prescribed in accordance with the recommended treatment regimens included in the Interim Guidelines for the prevention, diagnosis and treatment of COVID-19 validated of the time of the study
|
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of patients with COVID-19 severity increase as compared from baseline to Visit 4
Time Frame: From baseline to Visit 4 (days 14-15)
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Patient severity score at screening and during treatment was determined as per сurrent clinical Guidelines
|
From baseline to Visit 4 (days 14-15)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical status changes according to the WHO Ordinal Scale ranges from 0 (uninfected) to 8 (dead)
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)
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The score as per the categorical ordinal clinical improvement WHO scale
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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)
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Clinical status deterioration incidence according to the WHO Ordinal Scale ranges from 0 (uninfected) to 8 (dead) by ≥ 1 category
Time Frame: From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)
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The proportion of patients with clinical status deterioration as per the categorical ordinal clinical improvement on the WHO scale of ≥1 category
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From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)
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Achievement of clinical status 0 according to the WHO Ordinal Scale ranges from 0 (uninfected) to 8 (dead)
Time Frame: From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)
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The proportion of patients with category 0 as per the categorical ordinal clinical improvement on the WHO scale
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From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)
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Prevalence 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)
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The proportion of patients with negative SARS-CoV-2 RNA test
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From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)
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Symptoms intensity score as per COVID-19 Related Symptom 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)
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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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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)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dmitriy Pushkar, Academician, Moscow State Clinical Hospital №50
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- L.A. Balykova, N.M. Selezneva, E.I. Gorshenina, O.I. Shepeleva, N.V. Kirichenko, E.N. Simakina, K.B. Kolontarev, D.Yu. Pushkar, D.N. Zemskov, K.Ya. Zaslavskaya, S.M. Noskov, A.V. Taganov, P.A. Bely. modern directed antiviral COVID-19 therapy: results of multicenter clinical effectiveness and safety study of fixed nirmatrelvir+ritonavir combination. Pharmacy & Pharmacology. 2022;10(4):. DOI: 10.19163/2307-9266- 2022-10-4-
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 17, 2021
Primary Completion (Actual)
June 1, 2022
Study Completion (Actual)
June 1, 2022
Study Registration Dates
First Submitted
October 31, 2022
First Submitted That Met QC Criteria
October 31, 2022
First Posted (Actual)
November 1, 2022
Study Record Updates
Last Update Posted (Actual)
April 10, 2023
Last Update Submitted That Met QC Criteria
April 6, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ritonavir
Other Study ID Numbers
- NR-012022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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