CTRI/2022/03/040757已完成未知
Guar gum Galactomannan- PROlectin M, a nucleocapsid TErminal GaleCTin antagonist for COVID-19 (PROTECT), a Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety among asymptomatic to moderately-severe, ambulatory patients
Dr Surender Reddy0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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. Male or Female patient of >=â??18 years of age, willing and able to
- •provide written informed consent for participation in the study
- •and ready to comply with the study procedures and schedule.
- •2. Patient having a positive diagnosis for presence of SARS-CoV-
- •2, obtained from a recently performed rRT-PCR (<= 3 days) with
- •any 1 of the following:
- •i. Ct value <= 25
- •ii. Hospitalized for having classical (CDC defined)
- •symptoms of COVID-19 (onset <= 5 days)
- •iii. High risk category of COVID-19: blood group
- •type A-positive type 2 diabetes, or other chronic
- •disease known to have higher morbidity risk with
- •SARS-CoV-2 infection.
- •3. Patient has the ability to take oral medication and be willing to
- •adhere to the trial protocol regimen of repeated swab
- •collections and frequent follow up for 29 days.
- •4. Females of child bearing potential who has been using a highly
- •effective contraception for at least 1 month prior to screening
- •and agrees to continue using it during the study
排除标准
- •Oxygen Saturation levels (SpO2) <= 94% on room air.
- •6. Female patients who are pregnant or breastfeeding.
- •7. Patients with any active malignancy or undergoing active
- •chemotherapy.
- •8. Patients who are currently receiving or have received any
- •investigational treatment for COVID-19 within 30 days prior to
- •9. In the opinion of the Investigator, the participation of the patient
- •in the study is not in the patientâ??s best interest, or the patient
- •has any medical condition that does not allow the study
- •protocol to be followed safely.
- •10. Patients with known allergies to any of the components used in
- •the formulation of the interventions.
研究者
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