COVID-19Phase 3NCT05595824
Open Multicenter Study for Assessment of Efficacy and Safety of Molnupiravir in Adult Patients With COVID-19
A Phase 3 study testing Molnupiravir (Esperavir) in people with COVID-19, run by Promomed, LLC at 12 sites in Russia.
Trial 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. 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?
- Molnupiravir (Esperavir)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 12 sitesRussia
- Study dates
- 1 Dec 2021to 11 Mar 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; diarrhea; 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.
- 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.
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- 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).
- Pregnant or lactating women, or women planning a pregnancy.
- Participation in another clinical study within 3 months prior to enrollment in the present study.
- Other conditions investigator considers as preventing the patient from inclusion in the study.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Russia12 sites
Regional Budget 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
Professorskaya klinika, LLC
Perm
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 Budget Healthcare Institution "Clinical hospital No. 1"
Smolensk
Smolensk State Medical University of Ministry of Health of the Russian Federation
Smolensk
Uromed, LLC
Smolensk
State Budgetary Healthcare Institution of Yaroslavl Region "Clinical hospital No. 3"
Yaroslavl
About this study
Official title: 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.
Read the 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
- Conditions
- COVID-19
- Being tested
- Molnupiravir (Esperavir), Standard of care
- Keywords
- SARS-CoV-2, Molnupiravir, Esperavir
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molnupiravir (Esperavir)Drug
Also called JCBC00101
Capsules 800 mg, 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'(Version 14 of 27.12.2021), or inforce at the time of the study
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). 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 Current clinical Guidelines, version 14 (December 27,2021).
Measured: From baseline to Visit 4 (days 14-15)
Secondary outcomes (6)
Clinical status changes as per the categorical ordinal clinical improvement WHO scale
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 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
Measured: 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
Measured: 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
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 Major Symptom Rating Scale.
The proportion of patients with Symptoms intensity score as per COVID-19 Major Symptom Rating 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Dec 2021
- Primary completion11 Mar 2022
- Study completion11 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promomed, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dmitriy Pushkar, Academician, Principal investigator, Moscow State Clinical Hospital №50
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595824
- Sponsor's protocol ID
- MOL-112021
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05595824
- Acronym / sponsor ID
- MOL-112021
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, Molnupiravir, Esperavir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Promomed, LLCUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 27 Oct 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 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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JCBC00101 (Molnupiravir, Esperavir) | Experimental | Drug: 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 |
| Standard of care | Active comparator | Drug: Standard of careGroup 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). |
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 (18 listed)
- 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.
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 |
|---|---|---|
| Molnupiravir (Esperavir)Also: JCBC00101Capsules 800 mg, 2 times a day with 12 ±2 hours interval for 5 days | Drug | JCBC00101 (Molnupiravir, Esperavir) |
| Standard of careThe 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 | 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 Current clinical Guidelines, version 14 (December 27,2021).
6 secondary outcomes
Clinical status changes as per the categorical ordinal clinical improvement WHO 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)
Clinical status deterioration incidence as per the categorical ordinal clinical improvement WHO scale by ≥ 1 category
Time frame: 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
Time frame: 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
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 Major Symptom Rating 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 27 Oct 2022.
- 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
12 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 Molnupiravir (Esperavir) in people with COVID-19, run by Promomed, LLC at 12 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 18 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 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
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 27 Oct 2022.