CTRI/2021/01/030795已完成2 期
A Single blind, randomized, placebo-controlled, exploratory clinical study to evaluate the safety and efficacy of ATRICOV 452 for the treatment of COVID-19 along with the standard of care.
Atrimed Pharmaceutical Pvt Ltd0 个研究点目标入组 95 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Both male and female adult populations aged from 18 to 60 years will be included in the study.
- •2.Confirmed RT-PCR positive for SARS CoV-2 and IgG â??ve symptomatic patients as determined by the principal investigator/ Physician.
- •3.Controlled Diabetes (Type 2 DM (Hb1Ac < 7) and Hypertension (Systolic BP <140 mm Hg or diastolic BP <90 mm Hg).
- •4.Patient with BMI from >=18 to <= 30 are included.
- •5.Patient is willing and able to comply with all trial requirements.
- •All the patients obtained written informed
- •consent form in English as well as native
- •language, according to national regulations.
排除标准
- •1.If the physician finds vulnerability based on the history, nutritional status, physical appearance, or any other reason.
- •2.Judgment of the physician on likely need of ICU admission.
- •3.Known hepatic & kidney disease.
- •4.Known hypersensitivity to usual standard of care drug.
- •5.Known patient of cardiovascular disease, including congenital and ischemic heart disease, congestive cardiac failure.
- •6.Uncontrolled Type 2 DM (Hb1Ac >7), Insulin dependent DM & Uncontrolled HTN (systolic BP>=140 mm Hg or diastolic BP>=90 mm Hg.
- •7.Patients with BMI <18 and > 30 (Obese) are not included in the study.
- •8.Hemoglobin < 8 gm/dl are excluded.
- •9.Known patient of HIV or on any other anti-viral medication for a disease other than Covid-19.
- •10.Pregnant and lactating women.
- •11.Presence of debilitating diseases like Tuberculosis, Rheumatoid arthritis, Carcinoma, Known case of inflammatory autoimmune diseases of any kind, neurodemyelinating diseases like Multiple sclerosis, Transverse myelitis, Thyroid, adrenal, pituitary endocrine disorders, Renal failure, Inflammatory bowel disease.
- •12.Patients who had participated in another clinical trial with in the previous 30 days.
- •13.Patients under immune suppressants and steroid (steroid for any other disease than Covid-19).
- •14.Signs and symptoms, haematological, imaging investigations show signs of severe COVID will be excluded.
- •15.Any other medical conditions that is considered as unsuitable for the study by investigator.
- •16.Patient is not willing to give inform consent form.
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