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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Hydroxychloroquine; Favipiravir; Kaletra; Lopinavir/Ritonavir
• Intervention / Treatment: Drug: Favipiravir; Drug: Hydroxychloroquine; Drug: Lopinavir / Ritonavir

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Mohammad Sadegh Bagheri Baghdasht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group; 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; 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.
Active Comparator: Control Group; 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; 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 Names: Kaletra

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Baqiyatallah Medical Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2020
• Primary Completion (Actual): April 5, 2020
• Study Completion (Actual): May 25, 2020

Study Registration Dates

• First Submitted: May 3, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antirheumatic Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; HIV Protease Inhibitors; Viral Protease Inhibitors; Antimalarials; Favipiravir; Ritonavir; Lopinavir; Hydroxychloroquine
• Other Study ID Numbers: IR.BMSU.REC.1399.017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No