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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04376814
• Other study ID #: IR.BMSU.REC.1399.017
• Status: Completed
• Phase: N/A
• Start date: March 29, 2020
• Est. completion date: May 25, 2020

Study information

• Verified date: May 2020
• Source: Baqiyatallah Medical Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 25, 2020
• Est. primary completion date: April 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Favipiravir
• Hydroxychloroquine
• Kaletra
• Lopinavir/Ritonavir

Intervention

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
• 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.
• Lopinavir / Ritonavir
Patients will be given 200/50 mg of Lopinavir / Ritonavir two times per day for seven days.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mohammad Sadegh Bagheri Baghdasht	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Baqiyatallah Medical Sciences University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	In-hospital mortality	Up to 28 days
Primary	long of hospitalization	long of hospitalization	Up to 28 days
Primary	Laboratory Treatment Response (Blood cell count)	Laboratory Treatment Response; return of blood cell count to normal	Up to 28 days
Primary	Laboratory Treatment Response (CRP )	Laboratory Treatment Response; return of CRP values to normal	Up to 28 days
Primary	Dyspnea	shortness of breath based on symptoms of Dyspnea and questioning the patient	Up to 28 days
Primary	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
Primary	Oxygen therapy	Oxygen therapy maximum flow during the day (lit/min)	Up to 28 days