COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53231

Dr K Sunil Naik

drsunilnaikggh@gmail.com

2021-03-17

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

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 <br/ > >2days.Patients with moderate symptoms (moderate symptoms cough,weakness fatigue,sore throat,fever <br/ > >38.50C,clinical signs ofpneumonia as per PI and features of <br/ >dyspnea/hypoxia including, respiratory rate greater than equal to 24 /min,resting <br/ >SpO265, Type 2 Diabetes Mellitus Obesity <br/ >BMI >30 <br/ >Moderate to severe asthma Appendix I <br/ >Smoking current or former Cancer active history <br/ >COPD, Chronic heart disease CHF,CAD, cardiomyopathy, <br/ >pulmonary hypertension

Less than 40 years and older than 80 years <br/ >With severe COVID-19 symptomsrequiring immediate hospitalization <br/ >(Severe COVID-19: pneumonia with respiratory rate >30 <br/ >breaths/min, severe respiratory distress, SpO2 2 days ago <br/ >usingoropharyngeal/nasal swab RT-PCR for Sars-Co-V2 <br/ >History of cardiopulmonary resuscitation <br/ >Patient with a known history of DVT, PE, stroke, atrial <br/ >fibrillation,mechanical heart valve, recent stent placement or any <br/ >other cardiovascular event or any other condition for which the <br/ >patient is takingsystemic anticoagulation/antiplatelet therapy (LMWH, <br/ >coumadin, clopidogrel and/or other similar classes of therapy)prior to <br/ >study enrollment. <br/ >Patients on corticosteroids <br/ >Subjects having history of organ failure or conditions requiring ICU <br/ >monitoring and treatment, such as severe liver disease, severe renal <br/ >dysfunction, upper gastrointestinal hemorrhage, disseminated <br/ >intravascular coagulation or any other condition that in the PIâ??s <br/ >opinion makes the subject unfit to participate <br/ >Respiratory failure, ARDS or need of immediate mechanical <br/ >ventilation upon presentation <br/ >History of acute exacerbation of comorbidity like heart failure, <br/ >diabetic ketoacidosis, myocardial infection, major cardiac rhythm <br/ >disorder or any other condition that in the PIâ??s opinion makes the <br/ >subject unfit to participate <br/ >History of or current hepatic failure or severely compromised liver <br/ >function, or renal failure or having chronic kidney disease or acute <br/ >renal failure <br/ >History of or currently receiving treatment for an endocrine disorder <br/ >like hypothyroidism, hyperthyroidism that is likely to affect the basal <br/ >heart rate. <br/ >HIV, HBsAg, HCV positive <br/ >Any condition causing immunodeficiency <br/ >Systemic connective tissue disease or any autoimmune disease that <br/ >is likely to affect HS-CRP levels <br/ >History of epilepsy/epileptic fit/convulsions in last 6 months or <br/ >currently on treatment for it <br/ >History of or currently having malignancy and being treated for <br/ >it.exception histologically confirmed and cured carcinoma in situ <br/ >Hypersensitivity reaction to Study drug/active control <br/ >Any psychiatric issue for which the subject is currently undergoing <br/ >treatment <br/ >Any history of drug/alcohol dependence within 30 days of screening <br/ >or current drug/alcohol dependence <br/ >Inability to understand the requirements of the Research Protocol <br/ >and follow the research procedures. <br/ >Pregnant or lactating <br/ >Not willing to use adequate contraception during study duration <br/ >Participation in any other clinical study less than 3 months before the <br/ >start of the study. <br/ >

2

Govt Medical College Govt General Hospital

40

80

India

Moderate disease at enrollment

3: Moderate disease at enrollment

62

1 To evaluate the efficacy of marketed colchicine <br/ >0.5 mg plus marketed Aspirin 75 mg given twice <br/ >daily at the same time in the management <br/ >of inflammation and thrombotic condition of <br/ >moderate COVID-19 disease through the <br/ >specific biomarkers <br/ >2. To evaluate the symptomatic improvement <br/ >through the NEWS score and 8-point ordinal <br/ >scoreTimepoint: First Treatment day day 1 and 15 days

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]