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)
Overview
- Phase
- Phase 3
- Intervention
- Molixan
- Conditions
- COVID-19
- Sponsor
- Pharma VAM
- Enrollment
- 330
- Locations
- 1
- Primary Endpoint
- WHO Ordinal Scale for Clinical Improvement
- Last Updated
- 4 years ago
Overview
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.
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: 1. Group 1. Standard therapy + Molixan; 2. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Molixan
30 mg/ml solution for intravenous and intramuscular injection. Pharmacotherapeutic group: Metabolic agent. ATC code: V03AX - other medicinal products
Intervention: Molixan
Placebo
Sol. of NaCl (Sodium chloride) - 0.9% Pharmacotherapeutic group: Regulators of water-electrolytic balance and acid-base balance. ATC: B05CB01 Sodium chloride
Intervention: Placebo
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Duration of hospitalization(28 days)
- Mechanical ventilation(28 days)
- Invasive mechanical ventilation(28 days)
- The transition of the disease to an extremely severe course(28 days)
- Fever(28 days)
- The dynamics of changes in the level of C-reactive protein(10 days)
- Stay in the intensive care unit(28 days)
- The dynamics of the National Early Warning Score (NEWS)(10 days)
- Mortality(28 days)
- Time to cancellation of oxygen support(28 days)
- The dynamics of residual symptoms(28 days)
- The dynamics of blood biochemical parameters(10 days)
- The dynamics of CT signs(14 days)