Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: J00-J99- Diseases of the respiratory system
Conditions
Interventions
None listed
Sponsors
ZOTA Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 2. Both male and female subjects will be included 3. Positive or pharyngeal/nasal swab RT-PCR for Sars- Co- V2. Diagnosed not more than 2 daysago(diagnosis 4. Either asymptomatic or have mild to moderate symptoms. Onset of symptoms within no more than 4 days If symptomatic, symptoms are mild (cough, weakness, sore throat, low grade fever 38.>=18 to 60 С, respiratory rate should not be more than 22 / min, resting SpO2 >95%, normal highly sensitive C-reactive protein (HS-CRP) ( 5. Signed informed consent/or consent given through text message, WhatsApp or e-mail. 6. Ability to understand the requirements of the Research Protocol and follow the research procedures. 7. Subject should be willing to be managed in isolation wards 8. Negative pregnancy test (for female participants) 9. Adequate contraception for study duration
Exclusion criteria
Exclusion criteria: 2. Both male and female subjects will be included 3. Positive or pharyngeal/nasal swab RT-PCR for Sars- Co- V2. Diagnosed not more than 2 daysago(diagnosis 4. Either asymptomatic or have mild to moderate symptoms. Onset of symptoms within no more than 4 days If symptomatic, symptoms are mild (cough, weakness, sore throat, low grade fever 38.>=18 to 60 С, respiratory rate should not be more than 22 / min, resting SpO2 >95%, normal highly sensitive C-reactive protein (HS-CRP) ( 5. Signed informed consent/or consent given through text message, WhatsApp or e-mail. 6. Ability to understand the requirements of the Research Protocol and follow the research procedures. 7. Subject should be willing to be managed in isolation wards 8. Negative pregnancy test (for female participants) 9. Adequate contraception for study duration Exclusion criteria 1. Less than= 60 years 2. With severe COVID-19 symptoms requiring immediate hospitalization 3. Investigator considers the subject unsuitable forCOROVYL TABLET 4. History of symptoms of more than4days 5. COVID-19 diagnosed >2 days ago using or pharyngeal/nasal swab RT-PCR forSars-Co- V2 6. History of cardiopulmonary resuscitation 7. 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 PIâ??s opinion makes the subject unfit to participate 8. Respiratory failure, ARDS or need of mechanical ventilation 9. History of acute exacerbation of co morbidity like heart failure, diabetic ketoacidosis, myocardial infection, major cardiac rhythm disorder or any other condition that in the PIâ??s opinion makes the subject unfit to participate 10. History of or current hepatic failure or severely compromised liver function, or renal failure or having chronic kidney disease or acute renal failure 11. History of or currently receiving treatment for an endocrine disorder like hypothyroidism, hyperthyroidism that is likely to affect the basal heart rate. 12. 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. 13. HIV, HBs Ag, HCV positive 14. Any condition causing immunodeficiency 15. Systemic connective tissue disease or any autoimmune disease that is likely to affect HS-CRP levels 16. History of epilepsy/epileptic fit/convulsions in last 6 months or currently on treatment forit 17. History of or currently having malignancy and being treated for it. (exception: histological confirmed and cured carcinoma insitu) 18. Hypersensitivity reaction to Study drug/placebo 19. Any psychiatric issue for which the subject is currently undergoing treatment 20. Any history of drug/alcohol dependence within 30 days of screening or current drug/alcohol dependence 21. Inability to understand the requirements of the Research Protocol and follow the research procedures. 22
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 TTCI using NEWS Score Time Frame First treatment date up to discharge dayPIs discretion as per patients health condition The median time in days from the start of treatment with the study drugplacebo to the persistent achievement of all of the following criteria Stopping a fever which is defined as a decrease in axillary temperature below 37°C without the use of anti pyretic drugs Respiratory rate 22min Oxygen saturation SPO2 95% when breathing in atmospheric air Measured using pulseoximetry Systolic blood pressure 600mmHg Pulse rate5190beatsminute Is conscious and alert Note Persistent achievement means the preservation of each of the criteria for at least 7days 2 TTIC using 7point ordinal scale 3 Rate of progression to severecritical COVID19 disease based on NEWS score Time frame First treatment date up to15days Timepoint: Day 1 Day 7 Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1Incidence of ICU admissions Time Frame28days 2 Subject survival rate Time Frame:28days 3Incidence of mechanical ventilation due to COVID19 infection Time Frame First treatment date up to 28days Timepoint: Day 1 Day 7 Day 14 | — |
Countries
India
Contacts
Public ContactSKumar
7H International
Outcome results
None listed