Multicenter Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficacy and Safety of Raphamin in the Treatment of Coronavirus Disease 2019 in Outpatients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 771
- 试验地点
- 36
- 主要终点
- Number of Participants With COVID-19 Progression to a More Severe Form
研究概览
简要总结
Multicenter double-blind placebo-controlled parallel-group randomized clinical trial of efficacy and safety of Raphamin in the treatment of coronavirus disease 2019 in outpatients.
详细描述
Design: multicenter, double blind, placebo-controlled, parallel group randomized clinical trial.
The study enrolls outpatients of either gender aged 18-75 years with increased body temperature > 37.5°C and other upper respiratory infection symptoms (cough, chest congestion, sore throat, nasal congestion/moderate rhinorrhea). The investigator should specify the patient's status of vaccination for COVID-19, influenza and other infections. Patients within the first four weeks after any vaccination/booster vaccination are not considered as candidates to participate in the study.
Nasopharyngeal swabs and rapid COVID-19 test are made after signing informed consent (two versions are used: 1) for patients consented for laboratory tests; 2) for patients without the consent).
Patients with a positive rapid test and presence of mild COVID-19 (upper respiratory infection symptoms, no symptoms of moderate or severe forms) within 24 hours after manifestation of the first disease symptoms are considered as candidates for the study. Oxygen saturation (SpO2) is measured by pulse oximetry in all patients (pulse oximeters are provided by the study sponsor). If SpO2 is ≥95%, a patient may be selected for the study. Baseline severity for COVID-19 symptoms is evaluated using the scoring system "Assessment of 14 Common COVID-19-Related Symptoms" (FDA, 2020). This scoring system assesses the follows symptoms:
- Stuffy or runny nose.
- Sore throat.
- Shortness of breath (difficulty breathing).
- Cough.
- Low energy or tiredness.
- Muscle or body aches.
- Headache.
- Chills or shivering.
- Feeling hot or feverish.
- Nausea (feeling like you wanted to throw up).
- Vomiting.
- Diarrhea.
- Sense of smell.
- Sense of taste.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 18-75 years old.
- •Diagnosis of new coronavirus infection COVID-19 based on medical examination: axillary temperature >37.5°C, upper respiratory infection symptoms, SpO2 ≥ 95%, no symptoms of moderate or severe forms.
- •The minimal baseline score for COVID-19-related symptoms defined as follows: at least two symptoms with a score of 2 or higher, with the exception of taste and smell where subjects may have a score of 1 or higher, and the absence of shortness of breath (difficulty breathing).
- •Positive rapid test for for SARS-CoV-2 (COVID-19).
- •The first 24 hours from the disease onset.
- •Patients giving their consent to use reliable contraception during the study.
- •Signed patient information sheet (informed consent form).
排除标准
- •Moderate and severe COVID-
- •The first four weeks after any vaccination/revaccination, including against COVID-19, influenza, pneumococcal and other infections.
- •Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.).
- •Patients requiring medications prohibited within the study.
- •Medical history or previously diagnosed primary and secondary immunodeficiency.
- •Medical history/suspicion of oncology of any localization (except for benign neoplasms).
- •Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in the clinical study.
- •Malabsorption syndrome, including congenital or acquired lactase or disaccharidase deficiency, galactosemia.
- •Allergy/ hypersensitivity to any of the components of the medications used in the treatment.
- •Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial.
- •Use of medications listed in "Prohibited concomitant therapy" within 4 weeks before the study entry.
- •Patients who, from the investigator's point of view, will fail to comply with the requirements of the trial or with the intake regimen of the study drugs.
- •Medical history of mental diseases, alcoholism or drug abuse which, according to the investigator's opinion, will interfere with the study procedures.
- •Participation in other clinical trials within 3 months prior to enrollment in this study.
- •The patient is related to the study center staff directly involved in the trial or is the immediate relative of the investigator. Immediate family is defined as a spouse, parents, children or siblings, whether natural or adopted.
- •The patient works for OOO "NPF "MATERIA MEDICA HOLDING" i.e. is the company's employee, part-time employee under contract or appointed official in charge of the trial, or their immediate family.
研究组 & 干预措施
Raphamin
Tablet for oral use.
干预措施: Raphamin (Drug)
Placebo
Tablet for oral use.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With COVID-19 Progression to a More Severe Form
时间窗: 28 days
Severity of COVID-19 is assessed in accordance with criteria presented in the current edition of the clinical recommendations of the Ministry of Health of the Russian Federation "Prevention, diagnosis and treatment of a new coronavirus infection (COVID-19)".
次要结局
- Time to Sustained Clinical Recovery After New Coronavirus Disease COVID-19.(28 days)
- Percentage of Hospitalized Patients(28 days)