Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05601167
Other study ID # NR-012022
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 17, 2021
Est. completion date June 1, 2022

Study information

Verified date April 2023
Source Promomed, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 264
Est. completion date June 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 °?); 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
nirmatrelvir/ritonavir
Tablets 300/100mg, 2 times a day with 12 ±2 hours interval for 5 days
Standard of care
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

Locations

Country Name City State
Russian Federation Regional Budgetary Healthcare Institution "Ivanovo Clinical Hospital" Ivanovo
Russian Federation Kirov State Medical University of Ministry of Health of the Russian Federation Kirov
Russian Federation State Budgetary Healthcare Institution City Clinical Hospital named after S. I. Spasokukotskiy of Moscow Healthcare Department Moscow
Russian Federation Regional Clinic Hospital of Ryazan Ryazan'
Russian Federation Ryazan State Medical University named after academician I.P. Pavlov of Ministry of Health of the Russian Federation Ryazan'
Russian Federation Avrora MedFort, LLC Saint Petersburg
Russian Federation OrCli Hospital, LLC Saint Petersburg
Russian Federation Ogarev Mordova State University of Ministry of Health of the Russian Federation Saransk
Russian Federation Regional State Budgetary Healthcare Institution "Clinical Hospital No. 1" Smolensk
Russian Federation Smolensk State Medical University of Ministry of Health of the Russian Federation Smolensk
Russian Federation State Budgetary Healthcare Institution of the Yaroslavl Oblast "Clinical Hospital No.3" Yaroslavl

Sponsors (2)

Lead Sponsor Collaborator
Promomed, LLC Sponsor GmbH

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

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-

Outcome

Type Measure Description Time frame Safety issue
Primary 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 ?urrent clinical Guidelines From baseline to Visit 4 (days 14-15)
Secondary 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 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)
Secondary 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 From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)
Secondary 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 From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)
Secondary Prevalence of patients with negative SARS-CoV-2 RNA test The proportion of patients with negative SARS-CoV-2 RNA test From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)
Secondary 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) 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)
See also
  Status Clinical Trial Phase
Withdrawn NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure