COVID-19Phase 3NCT05601167
Open Multicentre Study of the Safety and Efficacy Against COVID-19 of Nirmatrelvir/Ritonavir in the Adult Population
A Phase 3 study testing nirmatrelvir/ritonavir in people with COVID-19, run by Promomed, LLC at 11 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- nirmatrelvir/ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 11 sitesRussia
- Study dates
- 17 Feb 2021to 1 Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Russia11 sites
Regional Budgetary Healthcare Institution "Ivanovo Clinical Hospital"
Ivanovo
Kirov State Medical University of Ministry of Health of the Russian Federation
Kirov
State Budgetary Healthcare Institution City Clinical Hospital named after S. I. Spasokukotskiy of Moscow Healthcare Department
Moscow
Regional Clinic Hospital of Ryazan
Ryazan
Ryazan State Medical University named after academician I.P. Pavlov of Ministry of Health of the Russian Federation
Ryazan
Avrora MedFort, LLC
Saint Petersburg
OrCli Hospital, LLC
Saint Petersburg
Ogarev Mordova State University of Ministry of Health of the Russian Federation
Saransk
Regional State Budgetary Healthcare Institution "Clinical Hospital No. 1"
Smolensk
Smolensk State Medical University of Ministry of Health of the Russian Federation
Smolensk
State Budgetary Healthcare Institution of the Yaroslavl Oblast "Clinical Hospital No.3"
Yaroslavl
About this study
Official title: 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.
Read the 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
- Conditions
- COVID-19
- Being tested
- nirmatrelvir/ritonavir, Standard of care
- Keywords
- Nirmatrelvir/ritonavir, Skayvira, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nirmatrelvir/ritonavirDrug
Also called JTBC00201
Tablets 300/100mg, 2 times a day with 12 ±2 hours interval for 5 days
Standard of careDrug
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
| Study group | Role | What they receive |
|---|---|---|
| JTBC00201 (nirmatrelvir/ritonavir, Skayvira) | Experimental | 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 Receives: Drug: nirmatrelvir/ritonavir |
| Standard of care | Active comparator | 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 Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to Visit 4 (days 14-15)
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start17 Feb 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promomed, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Sponsor GmbH
- Responsible party
- Sponsor
- Investigators
- Dmitriy Pushkar, Academician, Principal investigator, Moscow State Clinical Hospital №50
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601167
- Sponsor's protocol ID
- NR-012022
- Status last verified
- Apr 2023
- First submitted
- 31 Oct 2022
- Last updated
- 10 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05601167
- Acronym / sponsor ID
- NR-012022
- Conditions
- COVID-19
- Keywords
- Nirmatrelvir/ritonavir, Skayvira, SARS-CoV-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Promomed, LLCUniversity, hospital or other
- Collaborators
- Sponsor GmbH
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JTBC00201 (nirmatrelvir/ritonavir, Skayvira) | Experimental | Drug: nirmatrelvir/ritonavirGroup 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 |
| Standard of care | Active comparator | Drug: Standard of careGroup 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nirmatrelvir/ritonavirAlso: JTBC00201Tablets 300/100mg, 2 times a day with 12 ±2 hours interval for 5 days | Drug | JTBC00201 (nirmatrelvir/ritonavir, Skayvira) |
| Standard of careThe 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 | Drug | Standard of care |
Primary outcome
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)
Patient severity score at screening and during treatment was determined as per сurrent clinical Guidelines
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- BackgroundL.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-
- Cyberleninka is an open access scientific electronic libraryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitriy Pushkar, Academician principal investigator
Moscow State Clinical Hospital №50
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nirmatrelvir/ritonavir in people with COVID-19, run by Promomed, LLC at 11 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05601167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.