A Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-Group, Multicentric, Phase II Clinical Study to Evaluate Safety and Efficacy of Azelastine 0.1% Nasal Spray in Non-hospitalized Patients with Mild COVID-19 Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 20
- 主要终点
- The primary endpoints of the study are:
研究概览
简要总结
This is a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicentric, Phase II clinical study which will be conducted in patients with mild COVID-19 infection not requiring hospitalization at time of screening for the study, with or without co-morbidities, to evaluate the safety and efficacy of Azelastine 0.1% nasal spray. The study is planned to be conducted at multiple sites in India.
After obtaining the informed consent, samples for Rapid Antigen Tests (RATs) will be taken to detect COVID-19 in the general population and suspected mild COVID-19 patients fulfilling the eligibility criteria. All patients detected positive on the RAT will be enrolled and the treatment will be initiated on the same day, as per the randomization schedule. Samples for laboratory tests and nasopharyngeal swabs (for RT-PCR test as confirmatory diagnosis of COVID-19) will also be collected on the same day. If the RT-PCR test is positive, (with or without symptoms) the patients will be continued in the study and if found negative, such patients will be considered screen failuresand taken off from the study. All cases of clinically significant laboratory abnormalities will be documented as part of medical history and followed up for clinically significant worsening and captured as adverse events. This study design will provide benefit to the patients of early intervention of the disease.
The study will have a total of 6 visits. Visit 1/screening visit can be a hospital OPD/home/quarantine center-based visit. All other subsequent visits will be home/quarantine facility visits which will be done by the site personnel for all study-related activities, as the patients will be quarantined. In case, the study personnel will not be able to visit the home/quarantine facility due to COVID-19 restrictions or any other unavoidable reasons, the study-related procedures will be performed via tele-video conferencing
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients must meet all the following inclusion criteria in order to participate in this study: 1.Patients or legally accepted representative (LAR) provides informed consent prior to initiation of any study procedures.
- •2.Patients or LAR understands and agrees to comply with planned study procedures.
- •3.Male or female patients ≥18 years of age at the time of enrollment.
- •4.Patients with positive Rapid Antigen Test for SARS-CoV-
- •5.Willing to provide nasopharyngeal swabs 6.For females: non-pregnant, non-lactating with adequate contraception until Day 11, or females unable to bear children (i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period).
排除标准
- •Patient’s meeting any of the following criteria are not eligible for the study: 1.Having any contraindication for the use of azelastine (including hypersensitivity to the active substance or other ingredients).
- •2.Patients requiring hospitalization (social admission will be an exception wherein the patient could have mild symptoms requiring quarantine, but no facility is available for the same and thereby hospitalization).
- •3.Patients with moderate (peripheral capillary oxygen saturation [SpO2] <93%) or severe COVID-19 disease (SpO2 <90%) based on MoH FW guidelines, Revised on 23-Sep-
- •4.Any concurrent antihistamine therapy (systemic as well).
- •5.Any concurrent nasal spray or any nasalia including nasal lavage fluid.
- •6.Inability to administer the nasal spray.
- •7.Patients with nasal structure abnormalities, including nasal ulceration, nasal mucosal erosion, large nasal polyps and marked septal deviations that significantly interfere with nasal airflow.
- •8.Patients with alcohol or drug dependence.
- •9.Patients receiving any concurrent anti-COVID therapy (including off-label use).
- •10.Where, in the opinion of the investigator, participation in this study will not be in the best interest of the patient or any other circumstances that prevent the patient from participating in the study safely 11.Specific vulnerable patients: patients who are detained or committed to institutions by law court or by legal authorities, such as psychiatric wards, prisons, or other state institutions.
- •12.Patients with a history of psychiatric illness.
- •13.Simultaneous participation in other clinical studies or previous participation within 30 days before inclusion.
- •Note: If the RT-PCR test is negative for a patient, that patient will be taken off from the study.
结局指标
主要结局
The primary endpoints of the study are:
时间窗: The primary endpoints of the study are: | Rate of COVID-19 related hospitalization in patients with | SARS-CoV-2 infection in the treatment group as compared to | control group (up to Day 11) | Decrease in mean virus load in individual patients estimated via | quantitative RT-PCR by using nasopharyngeal swabs (from | Baseline [Day 1] to Day 3, Day 6, and Day 11).
•Rate of COVID-19 related hospitalization in patients with SARS-CoV-2 infection in the treatment group as compared to control group
时间窗: The primary endpoints of the study are: | Rate of COVID-19 related hospitalization in patients with | SARS-CoV-2 infection in the treatment group as compared to | control group (up to Day 11) | Decrease in mean virus load in individual patients estimated via | quantitative RT-PCR by using nasopharyngeal swabs (from | Baseline [Day 1] to Day 3, Day 6, and Day 11).
•Decrease in mean virus load in individual patients estimated via quantitative RT-PCR by using nasopharyngeal swabs
时间窗: The primary endpoints of the study are: | Rate of COVID-19 related hospitalization in patients with | SARS-CoV-2 infection in the treatment group as compared to | control group (up to Day 11) | Decrease in mean virus load in individual patients estimated via | quantitative RT-PCR by using nasopharyngeal swabs (from | Baseline [Day 1] to Day 3, Day 6, and Day 11).
次要结局
- The secondary outcome of the study are:(•Safety assessment (occurrence of adverse events [AEs]) (post-randomization till Day 30). Safety assessments of patients who report COVID symptoms of mild COVID-19 on Day 30 will also be taken on Day 60 (±1 day) through a telephonic call)