Overview

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

Status:
Completed

Trial end date:
2020-05-25

Target enrollment:
0

Participant gender:
All

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Baqiyatallah Medical Sciences University

Treatments:

Favipiravir
Hydroxychloroquine
Lopinavir
Ritonavir

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.