Favipiravir Plus Hydroxychloroquine and Lopinavir/Ritonavir Plus Hydroxychloroquine in COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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COVID-19, Favipiravir, Kaletra, Hydroxychloroquine, Lopinavir/Ritonavir

Intervention / Treatment
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* Drug: Favipiravir
* Drug: Hydroxychloroquine
* Drug: Lopinavir / Ritonavir


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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>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. | Drug: Favipiravir<br>* 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<br>Drug: Hydroxychloroquine<br>* 200mg of Hydroxychloroquine two times per day will be given to patients for seven days in Test group, and Patients in Control group will be given a stat dose of 400mg Hydroxychloroquine tablets two times per day.<br>|
| Active Comparator: Control Group<br>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. | Drug: Hydroxychloroquine<br>* 200mg of Hydroxychloroquine two times per day will be given to patients for seven days in Test group, and Patients in Control group will be given a stat dose of 400mg Hydroxychloroquine tablets two times per day.<br>Drug: Lopinavir / Ritonavir<br>* Patients will be given 200/50 mg of Lopinavir / Ritonavir two times per day for seven days.<br>* Other names: Kaletra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | In-hospital mortality | Up to 28 days | 
| long of hospitalization | long of hospitalization | Up to 28 days | 
| Laboratory Treatment Response (Blood cell count) | Laboratory Treatment Response; return of blood cell count to normal | Up to 28 days | 
| Laboratory Treatment Response (CRP ) | Laboratory Treatment Response; return of CRP values to normal | Up to 28 days | 
| Dyspnea | shortness of breath based on symptoms of Dyspnea and questioning the patient | Up to 28 days | 
| Oxygen saturation without supplemental oxygen. | Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes. | Up to 28 days | 
| Oxygen therapy | Oxygen therapy maximum flow during the day (lit/min) | Up to 28 days |