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临床试验/NCT04376814
NCT04376814已完成不适用

The Regimen of Favipiravir Plus Hydroxychloroquine Can Accelerate Recovery of the COVID-19 Patients With Moderate Severity in Comparison to Lopinavir/Ritonavir Plus Hydroxychloroquine Regimen: an Open-label, Non-randomized Clinical Trial Study

Baqiyatallah Medical Sciences University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年3月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Mortality

研究概览

简要总结

This is an open-label, non-randomized clinical trial study. The number of 40 COVID-19 patients with moderate severity will be admitted in progressive care units (PCUs) and intensive care units (ICUs) enrolled in the study. The sampling will be purposive and based on the same independent variables, including age, gender, past medical histories, and the situation of the patient at the admission day, and ventilator support. The patients will be allocated into two groups with different regimens. Group "A" (regimen A)will be defined as Favipiravir 1600 mg a first dose and 600 mg in 3 divided doses daily plus 400 mg in 2 divided doses of Hydroxychloroquine every day. The group "B" (regimen B) will be contained 400 mg of Lopinavir/Ritonavirin 2 divided doses plus the first dose (400 mg) of Hydroxychloroquine. Hydroxychloroquine will not be used for adverse drug reactions. The regimen remained at least 7 up to 10 days.

Data will be analyzed using statistical package for social sciences (SPSS) version 18 (SPSS Inc. Chicago, IL, USA) for windows. The variables will be compared using independent and paired T-test for normally distributed variables and Wilcoxon, Chi-square for non-normal distributed variables. The Kaplan Meier test will be used for survival analysis and the one-sample Kolmogorov-Smirnov test for the evaluation of distributions.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19
  • Requiring hospitalization
  • Patient's age between 16 and 100 years
  • Signed informed consent form

排除标准

  • Receiving other antiviral medications such as (Kaletra, Ribavirin, Oseltamivir)
  • Chronic liver or renal failure
  • HIV; GI bleeding
  • Pregnancy
  • Lactation
  • QT interval > 500 ms.

研究组 & 干预措施

Test Group

Experimental

In this group, Patients will be given a stat dose of 1600mg Favipiravir tablets for the first time, and for next time they will be given 600mg of favipiravir tablets three times per day for 7 days, plus 200mg of Hydroxychloroquine two times per day will be given to patients for 7 days.

干预措施: Favipiravir (Drug)

Test Group

Experimental

In this group, Patients will be given a stat dose of 1600mg Favipiravir tablets for the first time, and for next time they will be given 600mg of favipiravir tablets three times per day for 7 days, plus 200mg of Hydroxychloroquine two times per day will be given to patients for 7 days.

干预措施: Hydroxychloroquine (Drug)

Control Group

Active Comparator

In this group, Patients will be given a stat dose of 400mg Hydroxychloroquine tablets plus 200/50 mg of Lopinavir/Ritonavirtwo times per day for seven days.

干预措施: Hydroxychloroquine (Drug)

Control Group

Active Comparator

In this group, Patients will be given a stat dose of 400mg Hydroxychloroquine tablets plus 200/50 mg of Lopinavir/Ritonavirtwo times per day for seven days.

干预措施: Lopinavir / Ritonavir (Drug)

结局指标

主要结局

Mortality

时间窗: Up to 28 days

In-hospital mortality

Dyspnea

时间窗: Up to 28 days

shortness of breath based on symptoms of Dyspnea and questioning the patient

long of hospitalization

时间窗: Up to 28 days

long of hospitalization

Laboratory Treatment Response (Blood cell count)

时间窗: Up to 28 days

Laboratory Treatment Response; return of blood cell count to normal

Laboratory Treatment Response (CRP )

时间窗: Up to 28 days

Laboratory Treatment Response; return of CRP values to normal

Oxygen saturation without supplemental oxygen.

时间窗: Up to 28 days

Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes.

Oxygen therapy

时间窗: Up to 28 days

Oxygen therapy maximum flow during the day (lit/min)

次要结局

未报告次要终点

研究者

发起方
Baqiyatallah Medical Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammad Sadegh Bagheri Baghdasht

Principal Investigator

Baqiyatallah Medical Sciences University

研究点 (1)

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