Open Multicenter Study for Assessment of Efficacy and Safety of Molnupiravir in Adult Patients With COVID-19

Open Multicenter Study for Assessment of Efficacy and Safety of the Drug JCBC00101, Capsules (PROMOMED RUS LLC, Russia) in Relation to COVID-19 in Adult Population

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Molnupiravir (Esperavir); Drug: Standard of care

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 Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Ivanovo, Russian Federation
    • Regional Budget Healthcare Institution "Ivanovo clinical hospital"
  • Kirov, Russian Federation
    • Kirov State Medical University of Ministry of Health of the Russian Federation
  • Moscow, Russian Federation
    • State Budgetary Healthcare Institution City Clinical Hospital named after S. I. Spasokukotskiy of Moscow Healthcare Department
  • Perm, Russian Federation
    • Professorskaya klinika, LLC
  • Ryazan', Russian Federation
    • Ryazan State Medical University named after academician I.P. Pavlov of Ministry of Health of the Russian Federation
  • Saint Petersburg, Russian Federation
    • Avrora MedFort, LLC
  • Saint Petersburg, Russian Federation
    • OrCli Hospital, LLC
  • Saransk, Russian Federation
    • Ogarev Mordova State University of Ministry of Health of the Russian Federation
  • Smolensk, Russian Federation
    • Smolensk State Medical University of Ministry of Health of the Russian Federation
  • Smolensk, Russian Federation
    • Regional State Budget Healthcare Institution "Clinical hospital No. 1"
  • Smolensk, Russian Federation
    • Uromed, LLC
  • Yaroslavl, Russian Federation
    • State Budgetary Healthcare Institution of Yaroslavl Region "Clinical hospital No. 3"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Availability of PIS Informed Consent Form signed and dated by a patient.
2. Male and female subjects aged 18 to 80 inclusive as of the time of signing the PIS Informed Consent Form.

3. 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.

4. Mild or moderate SARS-CoV-2 induced infection.
5. 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.
6. Disease onset (first symptom) within not more than 5 days prior to randomization .
7. The patient agrees and is able to take oral drug products.
8. 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:

1. Hypersensitivity to the study drug components.
2. Favipiravir intake within 7 days prior to screening.
3. Necessity to use drugs included the prohibited therapy list.
4. Hospitalization necessity or expected hospitalization due to COVID-19 within 48 hrs after randomization.
5. Severe and extremely severe disease signs as of the time of screening.
6. Vaccination within less than 4 weeks prior to screening.
7. Possible or confirmed moderate COVID-19 within 6 months prior to screening.
8. Possible or confirmed history of severe or very severe COVID-19.
9. Patients with chronic kidney disease on dialysis or with GFR < 30 mL/min as of the time of screening.
10. History of HIV, syphilis, HBV and/or HCV.
11. Blood components transfusion within 7 days prior to screening.
12. Alcohol, pharmacological and/or drug dependence (history and/or at the time of screening).
13. Schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric disorder (history or suspected) at the time of screening.
14. 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.
15. Unwillingness or inability of a patient to comply with the Protocol procedures (in the opinion of the investigator).
16. Pregnant or lactating women, or women planning a pregnancy.
17. Participation in another clinical study within 3 months prior to enrollment in the present study.
18. Other conditions investigator considers as preventing the patient from inclusion in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: JCBC00101
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

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.	Patient severity score at screening and during treatment was determined as per Current clinical Guidelines, version 14 (December 27,2021).	From baseline to Visit 4 (days 14-15)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Clinical status changes as per the categorical ordinal clinical improvement WHO scale	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)
Clinical status deterioration incidence as per the categorical ordinal clinical improvement WHO scale by ≥ 1 category	The proportion of patients with clinical status deterioration as per the categorical ordinal clinical improvement scale of ≥ 1 category	From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)
Prevalence of patients with category 0 as per categorical ordinal clinical improvement WHO scale	The proportion of patients with category 0 as per the categorical ordinal clinical improvement scale	From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)
Prevalence of patients with category 1 and less according to clinical improvement WHO scale	The proportion of patients with category 1 and less as per the categorical ordinal clinical improvement scale	From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)
Symptoms intensity score as per COVID-19 Major Symptom Rating Scale.	The proportion of patients with 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)

Collaborators and Investigators

• Sponsor: Promomed, LLC
• Investigators: Principal Investigator: Dmitriy Pushkar, Academician, Moscow State Clinical Hospital №50

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): March 11, 2022
• Study Completion (Actual): March 11, 2022

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Molnupiravir; Esperavir
• 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
• Other Study ID Numbers: MOL-112021

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