Clinical Study in the Treatment of Patients With COVID-19

NCT04780672 | Unknown Phase 3

• 1 other identifier: MNCV-III/2-2020
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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.
• Group 2 of comparison - Patients receive standard therapy and placebo.

Conditions

COVID-19

Keywords

COVID-19; METABOLIC DRUG; Severe course of COVID-19

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days

Secondary Outcomes (14)

• Mortality

  28 days

• Duration of hospitalization

  28 days

• Mechanical ventilation

  28 days

• Time to cancellation of oxygen support

  28 days

• Invasive mechanical ventilation

  28 days

Study Arms (2)

Molixan

ACTIVE COMPARATOR

30 mg/ml solution for intravenous and intramuscular injection. Pharmacotherapeutic group: Metabolic agent. ATC code: V03AX - other medicinal products

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

Drug: Placebo

Interventions

Molixan DRUG

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.

Also known as: Inosine glycyl-cysteinyl-glutamate disodium

Molixan

Placebo DRUG

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.

Also known as: Sodium chloride

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• Patients cannot be included in the study if at least one of the following criteria is met:
• Associated with the underlying disease:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pharma VAM: lead

Study Sites (1)

Yaroslavl Regional Clinical Hospital for War Veterans - The International Center for the Elderly "Healthy Longevity"

Yaroslavl, 150047, Russia

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

inosine glycyl-cysteinyl-glutamate disodium; Sodium Chloride

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)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Viktor Borisovich Filimonov

  Federal State Budgetary Educational Institution of Higher Education

  PRINCIPAL INVESTIGATOR

• Tamara Valerievna Gaigolnik

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

  PRINCIPAL INVESTIGATOR

• Halida Hanafievna Ganceva

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

  PRINCIPAL INVESTIGATOR

• Elena Petrovna Dmitrikova

  State Budgetary Institution of Healthcare of Moscow Region "Zhukovskaya City Clinical Hospital", Zhukovskiy, Moscow Region, Russian Federation

  PRINCIPAL INVESTIGATOR

• Mariya Evgen'evna Mozhejko

  Yaroslavl Regional Clinical Hospital for War Veterans - The International Center for the Elderly "Healthy Longevity"

  PRINCIPAL INVESTIGATOR

• Halit Saubanovich Haertynv

  Republican Clinical Infectious Diseases Hospital named after professor Agafonov

  PRINCIPAL INVESTIGATOR

• Zoya Gennad'evna Tatarinceva

  State Budgetary Healthcare Institution "Research Institute - Regional Clinical Hospital No. 1 named after Professor S. V. Ochapovsky" of the Ministry of Health of the Krasnodar Territory

  PRINCIPAL INVESTIGATOR

• Aleksandr Alekseevich Punin

  Regional State Budgetary Healthcare Institution "Smolensk Regional Clinical Hospital"

  PRINCIPAL INVESTIGATOR

• Dmitrij YUr'evich Konstantinov

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Borisovich Balazovskij

CONTACT

+7 (812) 714-10-10; vam@glutoxim.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 3, 2021
• Study Start: March 9, 2021
• Primary Completion: May 31, 2022
• Study Completion: September 30, 2022
• Last Updated: October 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date
• Access Criteria: Anyone who wishes to access the data.

Locations

RU (1)