Open Observational Study of Efficacy and Safety of Polyoxidonium in Complex Therapy of Hospitalized Patients With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 5
- 主要终点
- Clinical Status of the Patient (According to 7-point Ordinal Scale)
研究概览
简要总结
The study is designed as an open observational non-comparative study of Polyoxidonium®, lyophilizate for solution for injections and topical application, 12 mg in hospitalized patients with coronavirus disease (COVID-19).
详细描述
The study was planned as an observation of Polyoxidonium® administered in addition to Russian Ministry of Healthcare (MoH) guidance for standard COVID-19 treatment. Regimens have no limitations to the use of concomitant therapy. The aim of the study is to observe the safety and efficacy of Polyoxidonium®, lyophilizate for solution for injections, 12 mg in addition to complex treatment of hospitalized patients with COVID-19.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The hospitalized patient was administered Polyoxidonium, according to the instruction for medical usage in complex with Russian MoH guidance for treatment of COVID-
- •Verified coronavirus disease COVID-19, and at least one of the following:
- •severe disease: mechanical ventilation or oxygen supply required with blood oxygen saturation (SpO2) ≤ 94% on room air or tachypnea, respiratory rate ≥ 24 breaths per minute,
- •mild-moderate disease: SpO2 > 94% on room air or respiratory rate < 24 breaths per minute.
- •The patient signed an Informed Consent form for participation in this study.
- •The patient can understand all protocol requirements, perform the study procedures, and agree to all limitations specified in the protocol.
- •Male and female patients from 18 years of age.
- •Confirmed diagnosis of coronavirus disease (COVID-19): laboratory-confirmed Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen prior to inclusion.
排除标准
- •Pregnancy or breastfeeding.
- •Pathological condition that the study doctor considers significant enough to prevent enrolment of this patient.
- •Participation in any clinical study within 30 days before the Informed Consent form provided.
- •Hypersensitivity and/or intolerability to any ingredient of the investigational product.
- •Acute or chronic renal failure.
研究组 & 干预措施
Adult patients hospitalized with COVID-19
Patients eligible for enrollment into the study
干预措施: Polyoxidonium (Drug)
结局指标
主要结局
Clinical Status of the Patient (According to 7-point Ordinal Scale)
时间窗: Day 1 (Baseline), Day 15
Subject clinical status using the 7-point Ordinal Scale, specified as the primary endpoint in the WHO Master Protocol on day 15 as compared to baseline (1 - Not hospitalized, no limitations on activities; 2 - Not hospitalized, limitation on activities; 3 - Hospitalized, not requiring supplemental oxygen; 4 - Hospitalized, requiring supplemental oxygen; 5 - Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6 - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 7 - Death).
次要结局
- Time to Improvement in Clinical Status of the Patient (According to Ordinal Scale) by 1 Point for Each OS Score(Days 1 - 29.)
- Clinical Status of the Patient (According to National Early Warning Score (NEWS Scale))(Days 1 - 29.)
- Number of Patients Requiring Supplementary Oxygen(Days intervals 1 (baseline), 3, 5, 8, 11, 15, 29.)
- Hospitalisation Duration(Days 1 - 29)
- Mortality(Days 1 - 29.)
- The Number of Participants With Serious Adverse Events(Days 1 - 29.)
- The Number of Participants With Adverse Events(Days 1 - 29.)
- Number of Participants With Discontinuation of Drug Administration(Days 1 - 17.)