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临床试验/NCT04473261
NCT04473261Unknown1 期

Efficacy of Iodine Complex in Mild to Moderate COVID-19 Patients

Sohaib Ashraf1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年7月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
发起方
Sohaib Ashraf
入组人数
200
试验地点
1
主要终点
HRCT chest

研究概览

简要总结

The objective of this study is to measure the effect of Iodine complex in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.

详细描述

The proposed study is a placebo-controlled, add-on, randomized trial using parallel group designs. This is a close-label and adaptive, multi-centered design with 1:1:1:1 allocation ratio and superiority framework.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

empty capsule will be given as a placebo

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Positive PCR with mild to moderate disease

排除标准

  • Allergic to iodine
  • Any co-morbidity other than hypertension and dietetics

研究组 & 干预措施

Iodine Complex (Capsule form)

Experimental

Iodine Complex) capsule (200mg) will be given three times a day

干预措施: Iodine Complex (Drug)

Iodine Complex (Syrup form)

Experimental

Iodine Complex syrup form (40ml) will be given three times a day

干预措施: Iodine Complex (Drug)

Standard Care Alone

Placebo Comparator

Placebo as empty capsule. Treatment will be given for all 4 arms will be receiving standard care as per version 3.0 of clinical management guidelines for COVID-19 established by the Ministry of National Health Services of Pakistan COVID-19 guidelines of the study setting.

干预措施: Placebo (Drug)

Iodine Complex (Nasal Spray)

Experimental

Iodine complex throat spray of 2 puffs three times a day.

干预措施: Idoine Complex (Drug)

结局指标

主要结局

HRCT chest

时间窗: 14 days

Time taken for radiological improvement

qRT-PCR

时间窗: 14 days

Time taken for viral load clearance

次要结局

  • Severity of Symptoms(14 days)

研究者

发起方
Sohaib Ashraf
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sohaib Ashraf

Post-Graduate Resident Cardiology

Sheikh Zayed Federal Postgraduate Medical Institute

研究点 (1)

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