COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54560

Dr R M Chhabra

Chhabradrrm@gmail.com

2021-04-06

Recruiting

RCT

Randomized

Parallel

Not reported

multi-center

Treatment

Subjects meeting all the following criteria will be included in the study: <br/ > <br/ >1.Male & Female patients with age ranging from 40 to 65 years (both inclusive)& female (non-pregnant, non-lactating, post-menopausal, surgically sterilized or practicing a reliable method of birth control during the duration of study) <br/ > <br/ >2.Clinically stable condition for at least 6 months before enrollment. <br/ > <br/ >3.Confirmed diagnosis of at least moderate COVID-19 symptoms demonstrated by: <br/ >a.Positivity in RT-PCR 2019-nCov test on respiratory tract (nasopharyngeal / oropharyngeal) specimens. <br/ >b.Presence of clinical features of dyspnea and/or hypoxia, fever, cough, including SpO2 < 94% (range 90-94%) on room air, Respiratory Rate > 24 and < 30 breaths per minute. <br/ > <br/ >4.Significant COVID-19 symptoms, and judged by the treating doctor to be at high risk of progression to severe category due to presence of any of the following: <br/ >a.Having at least one of the high-risk criteria, i.e, obesity (BMI â?¥ 30 kg/m2), diabetes mellitus, uncontrolled hypertension (diastolic blood pressure > 90 mm Hg systolic blood pressure â?¥150 mm Hg), known respiratory disease (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary disease, <br/ >b.Demonstrating signs of cardiac injury due to Elevated troponin level, <br/ > <br/ >5.Patients who require hospitalization for control of disease at the time of study entry. <br/ > <br/ >6.Within 7 days from symptom onset or within 48 hours of laboratory diagnosis of SARS- CoV2. <br/ > <br/ >7.Able to take oral tablets and agreeing not to participate in any other study for duration of participation in this study. <br/ > <br/ >8.Willing to sign voluntary informed consent for participation in the study and willing to adhere to all protocol procedures. In case the subject is unable to provide informed consent than the same should be obtained from legally acceptable representative (LAR). <br/ >

1.History of present illness (will be based on treating physicianâ??s opinion) <br/ > <br/ >a.Neurological and neurodevelopmental disorders. <br/ >b.Congenital heart disease <br/ >c.Severe heart disease or a history of clinically significant arrhythmias which may affect participants safety (According to the ECG or medical history). Corrected QT interval of 450 milliseconds or higher (according to the Bazett formula) on a 12 lead surface ECG / Abnormal ECG (to eliminate concerns that a potential interaction between colchicine and hydroxychloroquine could lead to excess QT prolongation) <br/ > <br/ >2.Requirement of oxygen supplementation greater than 8L nasal cannula at the time of enrollment. <br/ > <br/ >3.Treating physician clinical judgement that the patient will require mechanical respiratory support within 24 hours. <br/ > <br/ >4. Patient currently in Septic shock or with hemodynamic instability requiring vasopressors. <br/ > <br/ >5.History of cirrhosis. <br/ > <br/ >6.A subject undergoing hemodialysis. <br/ > <br/ >7.Severe gastrointestinal failure, severe gastrointestinal disorders, or stomach ulcer. <br/ > <br/ >8.Patient is currently taking colchicine for other indications (gout or Familial Mediterranean Fever). <br/ > <br/ >9.Patient with inflammatory bowel disease (Crohns disease or ulcerative colitis), chronic diarrhea or malabsorption <br/ > <br/ >10.Severe Hepatic Insufficiency (ALT or AST greater than 5 times ULN) or Renal Failure (eGFR using the MDRD equation for all subjects less than 30 mL per min). <br/ > <br/ >11.Patient received Remdesivir, Sarilumab, Tocilizumab, Lopinavir, Ritonavir or other immunomodulator given for COVID-19 treatment prior to study entry. <br/ > <br/ >12.Patient is on (and cannot discontinue) a strong CYP3A4 inhibitor (e.g. clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, atazanavir), a moderate CYP3A4 inhibitor (e.g. diltiazem, verapamil, fluconazole, amprenavir, aprepitant, fosamprenavir) or a Pgp Inhibitor (e.g. cyclosporine, ranolazine). <br/ > <br/ >13.Patients who may require IL 6 inhibitors as per clinical judgment of the investigator for management of inflammation at the time of study entry. <br/ > <br/ >14. Pregnant or lactating women women of a childbearing age with a positive pregnancy test <br/ >

2

Laxai Life Sciences Pvt Ltd

40

65

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

84

Time to clinical improvement of 2-points on WHO 8-point ordinal scale <br/ > <br/ >Timepoint: 28 days (4 weeks) <br/ > <br/ >

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

Phase 2

[{"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"}]