Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 550
- 试验地点
- 11
- 主要终点
- Laboratory Result
研究概览
简要总结
To evaluate the effectiveness of Hydroxychloroquine Sulfate (200 mg orally 8hr thrice a day for 5 days) vs oseltamivir (75 mg orally twice a day for 5 days) vs Azithromycin (500 mg orally daily on day 1, followed by 250 mg orally twice a day on days 2-5) alone and in combination (in all seven groups), in clearing the coronavirus nucleic acid from throat and nasal swab and in bringing about clinical improvement on day 7 of follow-up (primary outcomes).
详细描述
A scientific taskforce notified by the Ministry of Science and Technology of the Government of Pakistan will oversee a comprehensive cohort study. Within this cohort, a multicenter, adaptive, randomized controlled trial will evaluate, among eligible SARS-Cov-2 (COVID-19) infected patients receiving standard supportive care who consent to randomization following a new diagnosis in Pakistan, if Hydroxychloroquine Sulfate alone (control intervention) vs a series of alternatives (comparator interventions) including Oseltamivir and Azithromycin alone and in combination with Hydroxychloroquine Sulfate is effective in clearing the coronavirus and improving the clinical course of the disease. Those not consenting to randomization will be followed up for outcomes of SARS-Cov-2 infection with supportive care only. Findings of this study are expected to inform clinical care and public health protocols and policies for management of SARS-Cov-2.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed SARS-CoV-2 (COVID-19) infection by a positive test result
- •Either gender
- •Symptomatic for example fever, dry Cough, difficulty to breathe
排除标准
- •Confirmed absence of SARS-CoV-2 (COVID-19) infection by a negative test result
- •Have chronic conditions such as heart disease, liver and kidney failure
- •Pregnant or currently lactating
- •Immunocompromise and/or systemic disease(s)
- •On other antiviral drugs
- •History of allergy to any of the drugs to be administered in this study
研究组 & 干预措施
Control Intervention
Hydroxychloroquine
干预措施: Hydroxychloroquine (Drug)
Comparator 1
Azithromycin
干预措施: Azithromycin (Drug)
Comparator 2
Oseltamivir
干预措施: Oseltamivir (Drug)
Comparator 3
Hydroxychloroquine + Azithromycin
干预措施: Hydroxychloroquine (Drug)
Comparator 3
Hydroxychloroquine + Azithromycin
干预措施: Azithromycin (Drug)
Comparator 6
Hydroxyquinine + Oseltamivir + Azithromycin
干预措施: Azithromycin (Drug)
Comparator 4
Hydroxychloroquine + Oseltamivir
干预措施: Hydroxychloroquine (Drug)
Comparator 4
Hydroxychloroquine + Oseltamivir
干预措施: Oseltamivir (Drug)
Comparator 5
Oseltamivir + Azithromycin
干预措施: Oseltamivir (Drug)
Comparator 5
Oseltamivir + Azithromycin
干预措施: Azithromycin (Drug)
Comparator 6
Hydroxyquinine + Oseltamivir + Azithromycin
干预措施: Hydroxychloroquine (Drug)
Comparator 6
Hydroxyquinine + Oseltamivir + Azithromycin
干预措施: Oseltamivir (Drug)
结局指标
主要结局
Laboratory Result
时间窗: Day 07 on follow-up
The laboratory-based primary outcome will be turning test negative for COVID-19 on RT-qPCR calculated as viral load of \< 150 i.u
Clinical Outcome
时间窗: Day 07 on follow-up
The clinical primary outcome will be improvement of two points on a seven-category ordinal scale shown below: 1. Not hospitalized, able to resume normal activities 2. Not hospitalized, but unable to resume normal activities 3. Hospitalization, not requiring supplemental oxygen 4. Hospitalization, requiring supplemental oxygen 5. Hospitalization, requiring noninvasive mechanical ventilation 6. Hospitalization, requiring invasive mechanical ventilation 7. Death
次要结局
未报告次要终点
研究者
Shehnoor Azhar
Study Coordinator
University of Health Sciences Lahore