Official Title
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
Brief Summary

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.

Completed
COVID-19
Favipiravir
Kaletra
Hydroxychloroquine
Lopinavir/Ritonavir

Drug: Favipiravir

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

Drug: Hydroxychloroquine

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.

Drug: Lopinavir / Ritonavir

Patients will be given 200/50 mg of Lopinavir / Ritonavir two times per day for seven days.
Other Name: Kaletra

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 16 Years ~ Maximum: 100 Years
Countries
Iran, Islamic Republic of
Locations

Mohammad Sadegh Bagheri Baghdasht
Tehran, Iran, Islamic Republic of

Baqiyatallah Medical Sciences University
NCT Number
MeSH Terms
COVID-19
Ritonavir
Lopinavir
Hydroxychloroquine
Favipiravir