A Clinical Study to evaluate the safety and efficacy of CoviToneâ?¢ in Mild to moderate Covid patients
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/10/028376
- Lead Sponsor
- Arber Biosciences Pte Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients testing positive for SARS-CoV-2 by rRT-PCR on a nasopharyngeal or oropharyngeal swab or patient who have tested positive within 5 days of the screening visit
2. Patients clinically assigned as mild (Patients with uncomplicated upper respiratory tract infection, may have mild symptoms such as fever, cough, sore throat, nasal congestion, malaise, headache without evidence of breathlessness or hypoxia)
3. Patients clinically assigned as moderate(Pneumonia with no signs of severe disease, respiratory rate >=24 breaths/minute, SpO2 <94% (90%-94%) on room air)
4.Females should have a negative serum pregnancy test at baseline; female patients of child bearing potential should either be abstinent or comply with one or more contraception methods (with low user dependency and failure rate of <1%) for the entire duration of the treatment period and until 90 days after receiving the last dose of study treatment
5. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator.
6. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment
7. Must be willing and able to give informed consent and comply with the study procedures
1. Patients clinically assigned as having severe COVID-19 disease (Severe Pneumonia (with respiratory rate >=30/minute and/or SpO2 < 90% in room air) or Acute Respiratory Distress Syndrome or Septic shock], critically ill patients and those currently requiring or anticipated to imminently require one or more forms of extracorporeal life support (eg mechanical ventilation, extracorporeal membrane oxygenation) in the judgement of the Investigator (on basis of COVID-19 disease severity, rate of progression, co-morbidities or complications) at the time of randomization or during the course of the study)
2.Patients with history of or one or more known comorbidities at screening (Uncontrolled Hypertension (systolic blood pressure >180 mmHg diastolic blood pressure >100 mmHg), Ischemic Heart Disease, Cardiac Failure , Uncontrolled Diabetes Mellitus ,Chronic obstructive pulmonary disease (COPD), Asthma or Interstitial Lung Disease, Malignancy ,Kidney Disease (Serum creatinine > 1.5 times upper limit) ,Liver disease (e.g. Child Pugh score >= B or AST (Aspartate Transaminase) >4 times upper limit)
Cardiac conduction delay (QTc > 500 msec) ,Glucose-6-phosphate dehydrogenase (G6PD) deficiency Psoriasis or porphyria ,Other underlying severe diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition)
3.In case of patients with symptoms associated with COVID-19 at screening assessment (i.e., one or more of fever, cough, sore throat, breathlessness, rapid respiratory rate, low oxygen saturation in blood, body ache, chills, chills with shaking, fatigue, headache, loss of smell, loss of taste, diarrhoea, nasal congestion or any other symptom considered by the Investigator to be reasonably associated with COVID-19), the first onset of symptoms was > 5 days before screening (not applicable for re-treated/relapsed patients).
4.History of recent blood donation , Immunodeficiency disease, Allergy, medication or supplement use that influences the immune system. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients , Inability to take oral medication, Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption, ,Concomitant medication/supplement which could affect the study ,Antiviral therapy prior to screening ,Any contraindication to blood sampling
Patients allergic to herbal products or any component of the study product
6. Female patients who are pregnant or lactating
7. Patients who are contemplating surgery/ female patients contemplating a pregnancy within 90 days after scheduled end of study treatment
8. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (e.g. Methotrexate, Cyclosporine etc.)
9. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
10. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the patient from completing the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in Covid-19 symptoms and assessment scalesTimepoint: Screening, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
- Secondary Outcome Measures
Name Time Method Changes in Biomarker levelTimepoint: Day 0, Day 6;Improvement in Clinical statusTimepoint: Screening, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6;Percentage of patients showing negative conversion (of detectable SARS-CoV-2 viral RNA) on nasopharyngeal/oropharyngeal swab by Day 6Timepoint: Day 0, Day 6