A Double Blind, Randomized, Placebo Controlled Study to Evaluate Efficacy and Safety of "VIRACIDE" in the Management of Corona Virus Disease 2019 (COVID-19)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 4
- 主要终点
- Number of Participants With 7-point Ordinal Scale Score Change From 3 to 1
研究概览
简要总结
This is a double blind randomized placebo controlled study will be conducted on 124 subjects, 50 years and older with mild or asymptomatic COVID-19. If symptomatic, symptoms are mild (cough, weakness, sore throat, low grade fever 38.50С, respiratory rate should not be more than 22 / min, resting SpO2 >95%, normal highly sensitive C-reactive protein (HS-CRP) (<10mg/L). There are no signs of dehydration, sepsis or shortness of breath.
The study will be conducted at two centers. There will be a screening visit at Day -4 followed by three visits at the center at Days 1, 7 and 15 and a follow-up visit on Day 28. All participants will be randomized to receive either ViraCide (investigational product) or matching placebo. All subjects will receive SOC therapy.
Note: If subject is discharged before Day 15 PI's discretion as per patients health condition, then assessments scheduled for Day 15 will be carried out on the discharge day (as far as possible and those not performed will be noted on appropriate CRF page) and Day 15 visit will be done telephonically.
详细描述
Day 1 Randomization, Vital Signs, Pulse oximetry, AE/SAE, Concomitant Medication, ViraCide/ Placebo treatment start, NEWS scoring; 7-point ordinal scoring Day 7 Physical Examination, Vital Signs, AE/SAE, Concomitant Medication, ViraCide/ Placebo Compliance check, Pulse oximetry; NEWS scoring; 7-point ordinal scoring.
(Note: If the subject is discharged on this day as per PI's discretion and patient's health condition then assessment scheduled for day 15 will be carried out on discharge day).
Day 15 Physical Examination, Vital Signs, AE/SAE, Concomitant Medication, ViraCide/ Placebo treatment end, RT-PCR for Sars- Co-V2, Hs-CRP, Safety Lab Tests, Pulse oximetry; NEWS scoring; 7-point ordinal scoring, ViraCide/ Placebo Compliance check, Lab assessment including urine analysis Day 28
Phone call follow up for time :
- until negative RT-PCR for Sars-Co- V2, COVID-19 related mortality,
- development of any COVID-19 symptom,
- development of any worsening of comorbid condition;
- Development of new AE/SAE; Resolution status of previous AE/SAEs
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Randomized, Double - Blind
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 years or older
- •Both male and female subjects will be included
- •Positive oropharyngeal/nasal swab RT-PCR for Sars-Co- V
- •Diagnosed not more than 2 days ago(diagnosis
- •Either asymptomatic or have mild symptoms. Onset of symptoms within no more than 4 days If symptomatic, symptoms are mild (cough, weakness, sore throat, low grade fever 38.50С, respiratory rate should not be more than 22 / min, resting SpO2 >95%, normal highly sensitive C-reactive protein (HS-CRP) (<10mg/L). There are no signs of dehydration, sepsis or shortness of breath.
- •Chronic stable medical conditions: diabetes mellitus, or hypertension, or chronic heart disease. Under treatment and controlled by medication
- •Signed informed consent/or consent given through text message, WhatsApp ore-mail.
- •Ability to understand the requirements of the Research Protocol and follow the research procedures.
- •Subject should be willing to be managed in isolation wards
- •Negative pregnancy test (for female participants)
- •Adequate contraception for study duration
排除标准
- •Less than 50years
- •With severe COVID-19 symptoms requiring immediate hospitalization
- •Investigator considers the subject unsuitable for ViraCide
- •History of symptoms of more than 4days
- •COVID-19 diagnosed >2 days ago using oropharyngeal/nasal swab RT-PCR forSars-Co-V2
- •History of cardiopulmonary resuscitation
- •Subjects having history of organ failure or conditions requiring ICU monitoring and treatment, such as severe liver disease, severe renal dysfunction, upper gastrointestinal hemorrhage, disseminated intravascular coagulation or any other condition that in the PI"s opinion makes the subject unfit to participate
- •Respiratory failure, ARDS or need of mechanical ventilation
- •History of acute exacerbation of comorbidity like heart failure, diabetic ketoacidosis, myocardial infection, major cardiac rhythm disorder or any other condition that in the PI"s opinion makes the subject unfit to participate
- •History of or current hepatic failure or severely compromised liver function, or renal failure or having chronic kidney disease or acute renal failure
- •History of or currently receiving treatment for an endocrine disorder like hypothyroidism, hyperthyroidism that is likely to affect the basal heart rate.
- •History of or currently under treatment for asthma [exception: patients with history of asthma, not on medications/inhalers/nebulizers for at least 6 months before study start), COPD, bronchiectasis, asbestosis and other such chronic lung conditions that can compromise SpO2 and RR.
- •HIV, HBsAg, HCV positive
- •Any condition causing immunodeficiency
- •Systemic connective tissue disease or any autoimmune disease that is likely to affect HS-CRP levels
- •History of epilepsy/epileptic fit/convulsions in last 6 months or currently on treatment for it
- •History of or currently having malignancy and being treated for it. (exception: histologically confirmed and cured carcinoma in situ)
- •Hypersensitivity reaction to Study drug/placebo
- •Any psychiatric issue for which the subject is currently undergoing treatment
- •Any history of drug/alcohol dependence within 30 days of screening or current drug/alcohol dependence
- •Inability to understand the requirements of the Research Protocol and follow the research procedures.
- •Pregnant or lactating;
- •Not willing to use adequate contraception during study duration
- •Participation in any other clinical study less than 3months before the start of the study.
结局指标
主要结局
Number of Participants With 7-point Ordinal Scale Score Change From 3 to 1
时间窗: First treatment date up to day 7, i.e. up to 1 week
Proportion of cases with 7-point ordinal scale score reduction from 3 to 1 till day 7. This score is associated with clinical improvement and a decrease in score indicates improvement in patient's clinical condition.
Time to a Negative COVID-19 Nucleic Acid Testing
时间窗: Time Frame: First treatment date up to 28 days
Time to COVID-19 nucleic acid testing negativity in oropharyngeal/nasal swab)
Rate of Progression on National Early Warning Score
时间窗: First treatment date up tp 28 days (28 days)
Rate of progression to the severe/critical COVID-19 disease
Rate of Progression on 7- Point Ordinal Scale
时间窗: First treatment date up to 28 days
Rate of progression to the severe/critical COVID-19 disease
Number of Participants With National Early Warning Score (NEWS) Change From 3 to 0
时间窗: First treatment date up to discharge day, an average of 1 week
The proportion of cases with National Early Warning Score reduction from 3 to 0 till discharge day between two groups. This score is associated with clinical risk and a decrease in score indicates a decrease in the risk to the patient and improvement in clinical condition.
次要结局
- Subject Survival(28 days)
- Incidence of Mechanical Ventilation(28 days)
- Change in Clinical or Laboratory Assessment of Comorbid Condition(28 days)
- ICU Admissions(Time frame: 28 days)
- Percent of Participants With Worsening Comorbid Condition(28 days)