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

NCT05595824 | Completed Phase 3

• 1 other identifier: MOL-112021
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 12

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.

Conditions

COVID-19

Keywords

SARS-CoV-2; Molnupiravir; Esperavir

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

JCBC00101 (Molnupiravir, Esperavir)

EXPERIMENTAL

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)

Standard of care

ACTIVE COMPARATOR

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

Interventions

Molnupiravir (Esperavir) DRUG

Capsules 800 mg, 2 times a day with 12 ±2 hours interval for 5 days

Also known as: JCBC00101

JCBC00101 (Molnupiravir, Esperavir)

Standard of care DRUG

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

Standard of care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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; diarrhea; 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.

You may not qualify if:

• Hypersensitivity to the study drug components.
• Favipiravir intake within 7 days prior to screening.
• Necessity to use drugs included the prohibited therapy list.
• Hospitalization necessity or expected hospitalization due to COVID-19 within 48 hrs after randomization.
• 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 chronic kidney disease on dialysis or with GFR \< 30 mL/min as of the time of screening.
• History of HIV, syphilis, HBV and/or HCV.
• Blood components transfusion within 7 days prior to 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).

Sponsors & Collaborators

• Promomed, LLC: lead

Study Sites (12)

Regional Budget Healthcare Institution "Ivanovo clinical hospital"

Ivanovo, Russia

Location

Kirov State Medical University of Ministry of Health of the Russian Federation

Kirov, Russia

Location

State Budgetary Healthcare Institution City Clinical Hospital named after S. I. Spasokukotskiy of Moscow Healthcare Department

Moscow, Russia

Location

Professorskaya klinika, LLC

Perm, Russia

Location

Ryazan State Medical University named after academician I.P. Pavlov of Ministry of Health of the Russian Federation

Ryazan, Russia

Location

Avrora MedFort, LLC

Saint Petersburg, Russia

Location

OrCli Hospital, LLC

Saint Petersburg, Russia

Location

Ogarev Mordova State University of Ministry of Health of the Russian Federation

Saransk, Russia

Location

Regional State Budget Healthcare Institution "Clinical hospital No. 1"

Smolensk, Russia

Location

Smolensk State Medical University of Ministry of Health of the Russian Federation

Smolensk, Russia

Location

Uromed, LLC

Smolensk, Russia

Location

State Budgetary Healthcare Institution of Yaroslavl Region "Clinical hospital No. 3"

Yaroslavl, Russia

Location

MeSH Terms

Conditions

COVID-19

Interventions

molnupiravir; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Dmitriy Pushkar, Academician

  Moscow State Clinical Hospital №50

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: December 1, 2021
• Primary Completion: March 11, 2022
• Study Completion: March 11, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (12)