COVID-19Phase 3NCT04780672

Clinical Study in the Treatment of Patients With COVID-19

A Phase 3 study testing Molixan in people with COVID-19, run by Pharma VAM at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

Multicenter, prospective, double-blind, placebo-controlled, randomized, parallel-group phase III study. The study is designed for 2 treatment groups: Group 1 of the investigational drug - Patients receive standard therapy and the investigational drug. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: COVID-19
What is being tested?: Molixan
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 330 participants
Where: 1 siteRussia
Study dates: 9 Mar 2021to 30 Sep 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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Hospitalized male and female patients aged 18 to 75 and weighing no more than 120 kg inclusively with a diagnosis of the severe course of COVID-19 confirmed by the result of a laboratory study for the presence of SARS-CoV-2 RNA using nucleic acid amplification methods (to be performed on Screening, or results with sampling 72 hours prior to Screening may be accepted);
Changes in the lungs on CT (X-ray) typical for viral damage (the damage size is significant or subtotal; CT 3-4);
One or more criteria for a severe course:
RR > 30/min
SpO2 ≤ 93%
PaO2 /FiO2 ≤ 300 mm Hg

Show all 49Show fewer

Decreased consciousness, agitation
Unstable hemodynamics (systolic blood pressure less than 90 mm Hg or diastolic blood pressure less than 60 mm Hg, urine output less than 20 ml/hour)
Arterial blood lactate > 2 mmol/l
qSOFA > 2 points
Signed informed consent of the patient to participate in the study*;
The patient's ability to adequately cooperate (the ability to understand the information provided about the clinical study, the willingness to comply with the requirements of the study protocol)*;
In case of impossibility of the criteria No. 4 and 5 fulfilling the decision on including the patient shall be taken by a medical council. After the normalization of the status the patient shall compulsorily be proposed to acquaint themselves with the Patient Information Leaflet and take a decision on further participation in the study (Informed Consent Form signing) or withdrawal.
For women with preserved reproductive function - a negative pregnancy test and consent to use adequate methods of contraception from the moment of inclusion in the study until the end of the study;
For men - consent to use adequate methods of contraception from the moment of inclusion in the study to the end of the study.
Non-inclusion criteria:
Patients cannot be included in the study if at least one of the following criteria is met:
Associated with the underlying disease:
Mild, moderate and extremely severe COVID-19 disease upon admission to the hospital;
A condition requiring invasive oxygen support;
Failure to meet the criteria for inclusion and severity of the condition in terms of the main parameters;
Related to the investigational drug, prior and concomitant therapy:
Hypersensitivity or individual intolerance to the components of the investigational drug according to the history;
Taking any antiviral or immunomodulatory drugs after the manifestation of COVID-19 (except for those planned for appointment as part of the study);
Associated with concomitant pathology:
According to the history and physical examination:
A history of active tuberculosis;
Impossibility of intravenous administration of the drug;
Severe, decompensated or unstable somatic diseases according to the history and outpatient card/medical history:
Child-Pugh class B and C cirrhosis;
Myocardial infarction, CVA/TIA, PE less than 3 months before the start of the study, large aortic aneurysm (more than 6 cm);
Type 1 diabetes mellitus. Diseases of the thyroid gland with decompensation.
The presence of signs of severe damage to the central nervous system (history of severe TBI, meningitis, consequences of CVA, encephalopathy of various origin, epilepsy, etc.);
Current severe blood disorders or history of such diseases (i.e. baseline anemia Hb<80, myeloid leukemia, myelodysplastic syndrome, etc.);
No less than 3 months after the surgery for coronary artery bypass grafting/stenting before inclusion in the study;
Malignant neoplasm of any localization at present or within 5 years prior to inclusion in the study, with the exception of completely healed carcinoma in situ;
Any other comorbidities or conditions that, in the opinion of the investigator, make it difficult to interpret the results of treatment or may limit the patient's participation in the study;
According to laboratory tests at screening:
A positive result for HIV, syphilis, hepatitis B and C at screening;
Associated with the patient compliance in the study:
A history of alcohol abuse, drug dependence or drug addiction;
Patients who, in the opinion of the investigator, are obviously or likely to be unable to understand and evaluate the information on this study as part of the informed consent signing process, in particular regarding the expected risks and possible discomfort;
Patient's inability or unwillingness to follow the rules for conducting and participating in the clinical study;
Severe visual and/or hearing impairments, severe speech impairments and/or other abnormalities that may prevent the patient from adequately cooperating during the study;
A history of mental illness;
Other:
Pregnancy;
Breast-feeding;
Participation in other clinical studies within 3 months prior to enrollment in this study.

Who cannot join

Erroneous inclusion (violation of inclusion/non-inclusion criteria).
Individual intolerance to the investigational drug.
Refusal of the patient to continue participating in the study/withdrawal of informed consent by the patient.
Termination of the study.

Trial locations and contacts

1 site in 1 country.

Mark Borisovich Balazovskij contact

+7 (812) 714-10-10

vam@glutoxim.ru

Russia1 site, 1 recruiting

Yaroslavl Regional Clinical Hospital for War Veterans - The International Center for the Elderly "Healthy Longevity"
Yaroslavl, 150047
Mariya Evgen'evna Mozhejko, 89056391139, mmozheiko@yandex.ru
Recruiting

Other trials in Russia

About this study

Official title: Clinical Study to Analyze the Safety and Efficacy of Molixan® as Part of Standard Therapy in the Treatment of Patients With the Severe Course of New Coronavirus Infection (COVID-19)

Multicenter, prospective, double-blind, placebo-controlled, randomized, parallel-group phase III study.

The study is designed for 2 treatment groups:

Group 1 of the investigational drug - Patients receive standard therapy and the investigational drug.
Group 2 of comparison - Patients receive standard therapy and placebo.

Read the detailed description

Patients with the severe course of COVID-19 infection confirmed by PCR laboratory test will be involved in the study on a voluntary basis.

In accordance with regulatory enactments, these patients receive specialized medical care in specialized medical institutions, where the conduct of the study is planned.

The study is planned as a double-blind, which will be achieved by using Molixan and placebo (0.9% NaCl solution) in the same packaging with the same labeling, indistinguishable in color and smell.

Patients will be randomized in an unpredictable manner using the IWRS system.

It is planned to divide patients into 2 parallel groups:

Group 1. Standard therapy + Molixan;
Group 2. Standard therapy + placebo. The regimen (1 or 2) assigned to each study subject will not be known to either the Investigator or the patient.

Conditions: COVID-19
Being tested: Molixan, Placebo
Keywords: COVID-19, METABOLIC DRUG, Severe course of COVID-19
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MolixanDrug
Also called Inosine glycyl-cysteinyl-glutamate disodium
The investigational drug in this study is Molixan in the dosage form of 30 mg/ml solution for intravenous and intramuscular injection. Against the background of standard therapy: Molixan® at a dose of 3.0 mg/kg per day is administered once intravenously (stream injection) with 0.9% sodium chloride solution at a volume ratio of 1:1 for 10 days.
PlaceboDrug
Also called Sodium chloride
Placebo will be used as a comparator drug and will be an analogue of the investigational drug without active substance. Against the background of standard therapy: Placebo at a dose of 3.0 mg/kg per day is administered once intravenously (stream injection) with 0.9% sodium chloride solution at a volume ratio of 1:1 for 10 days.

Study groups in NCT04780672
Study group	Role	What they receive
Molixan	Active comparator	30 mg/ml solution for intravenous and intramuscular injection. Pharmacotherapeutic group: Metabolic agent. ATC code: V03AX - other medicinal products Receives: Drug: Molixan
Placebo	Placebo comparator	Sol. of NaCl (Sodium chloride) - 0.9% Pharmacotherapeutic group: Regulators of water-electrolytic balance and acid-base balance. ATC: B05CB01 Sodium chloride Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

WHO Ordinal Scale for Clinical Improvement
The median time to reach the clinical improvement on the WHO Ordinal Scale for Clinical Improvement (follow-up period 28 days after initiation of treatment) using hazard ratio estimates.
Measured: 28 days

Secondary outcomes (14)

Mortality
All-cause mortality (follow-up period of 28 days after the start of treatment)
Measured: 28 days
Duration of hospitalization
Duration of hospitalization from the start of therapy, days (observation period of 28 days after the start of treatment)
Measured: 28 days
Mechanical ventilation
The need for mechanical ventilation, extracorporeal membrane oxygenation, non-invasive ventilation or high-flow oxygen delivery by nasal cannula (observation period of 28 days after the start of treatment).
Measured: 28 days
Time to cancellation of oxygen support
Time to cancellation of oxygen support, if available, days (observation period of 28 days after the start of treatment)
Measured: 28 days
Invasive mechanical ventilation
The need for invasive mechanical ventilation of the lungs (observation period of 28 days after the start of treatment)
Measured: 28 days
Stay in the intensive care unit
The need to stay in the intensive care unit (observation period of 28 days after the start of treatment).
Measured: 28 days
The transition of the disease to an extremely severe course
The frequency of the transition of the disease to an extremely severe course (observation period of 28 days after the start of treatment).
Measured: 28 days
Fever
Duration of fever (≥38оC), days (observation period of 28 days after the start of treatment)
Measured: 28 days
The dynamics of the National Early Warning Score (NEWS)
The dynamics of the National Early Warning Score (NEWS) decrease in comparison with the baseline value (observation period of 10 days).
NEWS uses six physiological measurements: respiratory rate; oxygen saturation; temperature; systolic blood pressure; heart rate and level of consciousness. Each scores 0-3 and individual scores are added together for an overall score. An additional one points are added if the patient is receiving oxygen therapy.
Higher scores mean a worse outcome.
Measured: 10 days
The dynamics of changes in the level of C-reactive protein
The dynamics of changes in the level of C-reactive protein compared with the baseline value (observation period of 10 days).
Measured: 10 days
The dynamics of residual symptoms
The dynamics of residual symptoms compared to baseline values (observation period of 10 days).
Measured: 10 days
The dynamics of residual symptoms
The dynamics of residual symptoms on the 28th day after the start of treatment.
Measured: 28 days
The dynamics of blood biochemical parameters
The dynamics of blood biochemical parameters in comparison with the initial value (observation period of 10 days) Any clinically significant deviations from laboratory parameters detected at visits after the first dosing of the drugs.
Biochemical blood assay: urea, creatinine, glucose, alanine aminotransferase, aspartate aminotransferase, bilirubin, albumin, lactate, lactate dehydrogenase, troponin, ferritin.
Local laboratories of research centers will be used for laboratory tests and assessments.
After collecting and verification 100% values of laboratory parameters according to the Protocol from all local laboratories, the units of measurement will be unified before Statistical process control by valid formulas for transitions.
Measured: 10 days
The dynamics of CT signs
The dynamics of CT signs on the 14th day after the start of therapy compared with the baseline value.
In the conclusion CT study, a probabilistic assessment of the relationship of the detected changes with COVID 19 according to international recommendations and the approximate volume of lung damage according to the "empirical" scale of assessment shall be given.
The scale is based on a visual assessment of the approximate volume of compacted lung tissue in both lungs: 1. Absence of characteristic manifestations (CT-0) 2. Minimum volume/site < 25% of lung volume (CT-1) 3. Average volume/site 25 - 50% of lung volume (CT-2) 4. Significant volume/site 50 - 75% of lung volume (CT-3) 5. Critical volume/site > 75% of lung volume (CT-4).
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 202130 Sep 2022

First posted3 Mar 2021
Study start9 Mar 2021
Primary completion31 May 2022 (estimated)
Study completion30 Sep 2022 (estimated)

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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 330 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04780672
Sponsor's protocol ID: MNCV-III/2-2020
Status last verified: Feb 2021
First submitted: 25 Feb 2021
Last updated: 11 Oct 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All of the individual participant data collected during the trial, after deidentification

Want to know more?

Mark Borisovich Balazovskij

+7 (812) 714-10-10

vam@glutoxim.ru

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study to Analyze the Safety and Efficacy of Molixan® as Part of Standard Therapy in the Treatment of Patients With the Severe Course of New Coronavirus Infection (COVID-19)
ClinicalTrials.gov ID: NCT04780672
Acronym / sponsor ID: MNCV-III/2-2020
Conditions: COVID-19
Keywords: COVID-19, METABOLIC DRUG, Severe course of COVID-19
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 330 participants (estimated)
Lead sponsor: Pharma VAMUniversity, hospital or other
Study start: 9 Mar 2021 (actual)
Primary completion: 31 May 2022 (estimated)
Study completion: 30 Sep 2022 (estimated)
First posted: 3 Mar 2021 (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.

Multicenter, prospective, double-blind, placebo-controlled, randomized, parallel-group phase III study.

The study is designed for 2 treatment groups:

Group 1 of the investigational drug - Patients receive standard therapy and the investigational drug.
Group 2 of comparison - Patients receive standard therapy and placebo.

Detailed description

Patients with the severe course of COVID-19 infection confirmed by PCR laboratory test will be involved in the study on a voluntary basis.

In accordance with regulatory enactments, these patients receive specialized medical care in specialized medical institutions, where the conduct of the study is planned.

The study is planned as a double-blind, which will be achieved by using Molixan and placebo (0.9% NaCl solution) in the same packaging with the same labeling, indistinguishable in color and smell.

Patients will be randomized in an unpredictable manner using the IWRS system.

It is planned to divide patients into 2 parallel groups:

Group 1. Standard therapy + Molixan;
Group 2. Standard therapy + placebo. The regimen (1 or 2) assigned to each study subject will not be known to either the Investigator or the patient.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Molixan	Active comparator	Drug: Molixan30 mg/ml solution for intravenous and intramuscular injection. Pharmacotherapeutic group: Metabolic agent. ATC code: V03AX - other medicinal products
Placebo	Placebo comparator	Drug: PlaceboSol. of NaCl (Sodium chloride) - 0.9% Pharmacotherapeutic group: Regulators of water-electrolytic balance and acid-base balance. ATC: B05CB01 Sodium chloride

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (49 listed)

Hospitalized male and female patients aged 18 to 75 and weighing no more than 120 kg inclusively with a diagnosis of the severe course of COVID-19 confirmed by the result of a laboratory study for the presence of SARS-CoV-2 RNA using nucleic acid amplification methods (to be performed on Screening, or results with sampling 72 hours prior to Screening may be accepted);
Changes in the lungs on CT (X-ray) typical for viral damage (the damage size is significant or subtotal; CT 3-4);
One or more criteria for a severe course:
Signed informed consent of the patient to participate in the study*;
The patient's ability to adequately cooperate (the ability to understand the information provided about the clinical study, the willingness to comply with the requirements of the study protocol)*;

Key exclusion criteria (4 listed)

Erroneous inclusion (violation of inclusion/non-inclusion criteria).
Individual intolerance to the investigational drug.
Refusal of the patient to continue participating in the study/withdrawal of informed consent by the patient.
Termination of the study.

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
MolixanAlso: Inosine glycyl-cysteinyl-glutamate disodiumThe investigational drug in this study is Molixan in the dosage form of 30 mg/ml solution for intravenous and intramuscular injection. Against the background of standard therapy: Molixan® at a dose of 3.0 mg/kg per day is administered once intravenously (stream injection) with 0.9% sodium chloride solution at a volume ratio of 1:1 for 10 days.	Drug	Molixan
PlaceboAlso: Sodium chloridePlacebo will be used as a comparator drug and will be an analogue of the investigational drug without active substance. Against the background of standard therapy: Placebo at a dose of 3.0 mg/kg per day is administered once intravenously (stream injection) with 0.9% sodium chloride solution at a volume ratio of 1:1 for 10 days.	Drug	Placebo

Primary outcome

WHO Ordinal Scale for Clinical Improvement
Time frame: 28 days
The median time to reach the clinical improvement on the WHO Ordinal Scale for Clinical Improvement (follow-up period 28 days after initiation of treatment) using hazard ratio estimates.

14 secondary outcomes

Mortality
Time frame: 28 days
Duration of hospitalization
Time frame: 28 days
Mechanical ventilation
Time frame: 28 days
Time to cancellation of oxygen support
Time frame: 28 days
Invasive mechanical ventilation
Time frame: 28 days
Stay in the intensive care unit
Time frame: 28 days
The transition of the disease to an extremely severe course
Time frame: 28 days
Fever
Time frame: 28 days
The dynamics of the National Early Warning Score (NEWS)
Time frame: 10 days
The dynamics of changes in the level of C-reactive protein
Time frame: 10 days
The dynamics of residual symptoms
Time frame: 10 days
The dynamics of residual symptoms
Time frame: 28 days
The dynamics of blood biochemical parameters
Time frame: 10 days
The dynamics of CT signs
Time frame: 14 days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification

Related trials for COVID-19

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

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.

Mark Borisovich Balazovskij contact

+7 (812) 714-10-10

vam@glutoxim.ru

Viktor Borisovich Filimonov principal investigator

Federal State Budgetary Educational Institution of Higher Education

Tamara Valerievna Gaigolnik principal investigator

Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency, Krasnoyarsk

Halida Hanafievna Ganceva principal investigator

Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Healthcare of the Russian Federation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Molixan in people with COVID-19, run by Pharma VAM at 1 site 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 49 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mark Borisovich Balazovskij (+7 (812) 714-10-10, vam@glutoxim.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WHO Ordinal Scale for Clinical Improvement (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04780672.

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 11 Oct 2021.