Open Multicenter Study for Assessment of Efficacy and Safety of Molnupiravir in Adult Patients With COVID-19
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: JCBC00101 (Molnupiravir, Esperavir) Group 1 (n=120) received the study drug JCBC00101, capsules 800 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 approved by the Russian Ministry of Health (version 14, December 27, 2021) or valid as of the time of the study |
Drug: Molnupiravir (Esperavir)
Capsules 800 mg, 2 times a day with 12 ±2 hours interval for 5 days
Other Names:
|
| Active Comparator: Standard of care Group 2 (n=120) 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 approved by the Russian Ministry of Health (version 14, December 27, 2021) or valid as of the time of the study by decision of the investigator and taking into accountthe availability of drugs at the study site (Favipiravir, Umifenovir, IFN α, used incombination with each other). |
Drug: Standard of care
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
|
Outcome Measures
Primary Outcome Measures
- Prevalence of patients with COVID-19 severity increase as compared from baseline to Visit 4. [From baseline to Visit 4 (days 14-15)]
Patient severity score at screening and during treatment was determined as per Current clinical Guidelines, version 14 (December 27,2021).
Secondary Outcome Measures
- Clinical status changes 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)]
The score as per the categorical ordinal clinical improvement WHO scale
- Clinical status deterioration incidence as per the categorical ordinal clinical improvement WHO scale by ≥ 1 category [From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)]
The proportion of patients with clinical status deterioration as per the categorical ordinal clinical improvement scale of ≥ 1 category
- Prevalence of patients with category 0 as per categorical ordinal clinical improvement WHO scale [From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)]
The proportion of patients with category 0 as per the categorical ordinal clinical improvement scale
- Prevalence of patients with category 1 and less according to clinical improvement WHO scale [From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)]
The proportion of patients with category 1 and less as per the categorical ordinal clinical improvement scale
- Prevalence 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)]
The proportion of patients with negative SARS-CoV-2 RNA test
- Symptoms intensity score as per COVID-19 Major Symptom Rating 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)]
The proportion of patients with Symptoms intensity score as per COVID-19 Major Symptom Rating Scale
Eligibility Criteria
Criteria
Inclusion Criteria:
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Availability of PIS Informed Consent Form signed and dated by a patient.
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Male and female subjects aged 18 to 80 inclusive as of the time of signing the PIS Informed Consent Form.
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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.
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Mild or moderate SARS-CoV-2 induced infection.
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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; diarrhea; anosmia; ageusia.
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Disease onset (first symptom) within not more than 5 days prior to randomization .
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The patient agrees and is able to take oral drug products.
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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:
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Hypersensitivity to the study drug components.
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Favipiravir intake within 7 days prior to screening.
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Necessity to use drugs included the prohibited therapy list.
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Hospitalization necessity or expected hospitalization due to COVID-19 within 48 hrs after randomization.
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Severe and extremely severe disease signs as of the time of screening.
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Vaccination within less than 4 weeks prior to screening.
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Possible or confirmed moderate COVID-19 within 6 months prior to screening.
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Possible or confirmed history of severe or very severe COVID-19.
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Patients with chronic kidney disease on dialysis or with GFR < 30 mL/min as of the time of screening.
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History of HIV, syphilis, HBV and/or HCV.
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Blood components transfusion within 7 days prior to screening.
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Alcohol, pharmacological and/or drug dependence (history and/or at the time of screening).
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Schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric disorder (history or suspected) at the time of screening.
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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.
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Unwillingness or inability of a patient to comply with the Protocol procedures (in the opinion of the investigator).
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Pregnant or lactating women, or women planning a pregnancy.
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Participation in another clinical study within 3 months prior to enrollment in the present study.
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Other conditions investigator considers as preventing the patient from inclusion in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Regional Budget Healthcare Institution "Ivanovo clinical hospital" | Ivanovo | Russian Federation | ||
| 2 | Kirov State Medical University of Ministry of Health of the Russian Federation | Kirov | Russian Federation | ||
| 3 | State Budgetary Healthcare Institution City Clinical Hospital named after S. I. Spasokukotskiy of Moscow Healthcare Department | Moscow | Russian Federation | ||
| 4 | Professorskaya klinika, LLC | Perm | Russian Federation | ||
| 5 | Ryazan State Medical University named after academician I.P. Pavlov of Ministry of Health of the Russian Federation | Ryazan' | Russian Federation | ||
| 6 | Avrora MedFort, LLC | Saint Petersburg | Russian Federation | ||
| 7 | OrCli Hospital, LLC | Saint Petersburg | Russian Federation | ||
| 8 | Ogarev Mordova State University of Ministry of Health of the Russian Federation | Saransk | Russian Federation | ||
| 9 | Regional State Budget Healthcare Institution "Clinical hospital No. 1" | Smolensk | Russian Federation | ||
| 10 | Smolensk State Medical University of Ministry of Health of the Russian Federation | Smolensk | Russian Federation | ||
| 11 | Uromed, LLC | Smolensk | Russian Federation | ||
| 12 | State Budgetary Healthcare Institution of Yaroslavl Region "Clinical hospital No. 3" | Yaroslavl | Russian Federation |
Sponsors and Collaborators
- Promomed, LLC
Investigators
- Principal Investigator: Dmitriy Pushkar, Academician, Moscow State Clinical Hospital №50
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MOL-112021