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

Baqiyatallah Medical Sciences University

Status: Completed

Conditions: COVID-19; Hydroxychloroquine; Favipiravir; Lopinavir/Ritonavir; Kaletra

Treatments: Drug: Favipiravir; Drug: Lopinavir / Ritonavir; Drug: Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT04376814

IR.BMSU.REC.1399.017

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 16 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Test Group

Experimental group

Description:

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.

Treatment:

Drug: Hydroxychloroquine

Drug: Favipiravir

Control Group

Active Comparator group

Description:

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.

Treatment:

Drug: Hydroxychloroquine

Drug: Lopinavir / Ritonavir