Anti-Coronavirus Therapies(ACT)to prevent progression of mild COVID-19 : Randomized Trials - ACT

Population Health Research Institute0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1) Symptomatic and RTPCR positive confirmed diagnosis of mild COVID-19. Mild disease is defined as per Government of India guidelines as follows:
•Ã¢â?¬Â¢ Patients with uncomplicated upper respiratory tract infection, may have mild symptoms such as fever, cough, sore throat, nasal congestion, malaise, headache.
•Ã¢â?¬Â¢ Without evidence of breathlessness or hypoxia (normal saturation)
•Ã¢â?¬Â¢ Managed at COVID care center (or quarantined at home as per revised guidelines for home isolation: https://www.mohfw.gov.in/pdf/RevisedHomeIsolationGuidelines.pdf).
•2) Age Ã¢â?°Â¥18 years.
•3) High risk: either age Ã¢â?°Â¥70 or at least one of the following: male; obesity (BMI Ã¢â?°Â¥30); chronic cardiovascular, respiratory or renal disease; active cancer; diabetes).
•4) Within 7 days (ideally 72 hours) of diagnosis, or worsening clinically.
•Additional details:
•Ã¢â?¬Â¢ The patients need to be recruited from fever clinic or from the hospitalÃ¢â?¬•s community care center.
•Ã¢â?¬Â¢ Baseline lab tests for blood count and serum creatinine to confirm eligibility need to be done
•Ã¢â?¬Â¢ Height and weight should be assessed at the time of recruitment

•1) Kidney disease (eGFR <15 mL/min/1.73m2); liver disease; pregnancy or lactation.
•2) Colchicine: allergy or planned use; current or planned use of cyclosporine, verapamil, HIV protease inhibitor, systemic azole antifungal, or macrolide antibiotic (except azithromycin).
•3) Aspirin: allergy or planned use; high risk of bleeding, current or planned use of other anti-thrombotic drugs (e.g., P2Y12 inhibitors, direct oral anticoagulants, vitamin K antagonists, heparins).
•4)(Patients >70 years, with known chronic kidney disease, or with a history of diabetes for more than 10 years should get creatinine [eGFR] tested within 72 hours of randomization)
•Additional details:
•Ã?Â· Serum creatinine value needs to be obtained for all patients before enrolment. Those patients with a calculated eGFR < 15mLl/min/1.73m2 should be excluded. A normal creatinine value estimated within the previous 90 days will be acceptable as a baseline value. However, in such cases, the creatinine should be repeated within three days of randomization.
•Ã?Â·Baseline liver function test to be done to rule out liver disease.
•Ã?Â·Urine pregnancy test (in women in reproductive age group) to be done to rule out pregnancy.

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