Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Marketed Colchicine 0.5mg given along marketed Asprin 75mg with SOC: Marketed Colchicine 0.5mg given along marketed Asprin 75mg with SOC twice daily and SOC
Control Intervention1: Marke
Sponsors
SRV Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 40-80 years old Both male and female subjects will be included Positive oropharyngeal/nasal swab RT-PCR for Sars-Co-V2. Diagnosed not more than 2 days ago diagnosis ?2days. Patients with moderate symptoms (moderate symptoms cough, weakness fatigue,sore throat,fever >38.50?,clinical signs of pneumonia as per PI and features of dyspnea/hypoxia including respiratory rate ?24 /min,resting SpO265 b Type 2 Diabetes Mellitus c Obesity BMI?30 d Moderate to severe asthma Appendix I e Smoking current or former f Cancer active history g COPD h Chronic heart disease CHF,CAD, cardiomyopathy, pulmonary hypertension
Exclusion criteria
Exclusion criteria: Less than 40 years and older than 80 years With severe COVID-19 symptomsrequiring immediate hospitalization (Severe COVID-19: pneumonia with respiratory rate >30 breaths/min, severe respiratory distress, SpO2 2 days ago usingoropharyngeal/nasal swab RT-PCR for Sars-Co-V2 History of cardiopulmonary resuscitation Patient with a known history of DVT, PE, stroke, atrial fibrillation,mechanical heart valve, recent stent placement or any other cardiovascular event or any other condition for which the patient is takingsystemic anticoagulation/antiplatelet therapy (LMWH, coumadin, clopidogrel and/or other similar classes of therapy)prior to study enrollment. Patients on corticosteroids 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 immediate mechanical ventilation upon presentation 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. 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/active control 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 3 months before the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 To evaluate the efficacy of marketed colchicine 0.5 mg plus marketed Aspirin 75 mg given twice daily at the same time in the management of inflammation and thrombotic condition of moderate COVID-19 disease through the specific biomarkers 2. To evaluate the symptomatic improvement through the NEWS score and 8-point ordinal scoreTimepoint: First Treatment day up to 15 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of marketed colchicine 0.5 mg plus marketed Aspirin 75 mg given twice daily at the same time in the management of moderate COVID-19 diseaseTimepoint: day 15 | — |
Countries
India
Contacts
Public ContactDr Vispute Abhay Shantaram
SRV Hospital
Outcome results
None listed