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

Not Applicable

Completed

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

• Registration Number: NCT04376814
• Lead Sponsor: Baqiyatallah Medical Sciences University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-29
• Primary Completion: 2020-04-05
• Status Verified: 2020-05
• Study First Submitted: 2020-05-03
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-06
• Study Completion: 2020-05-25
• Last Update Submitted: 2020-06-12
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Lopinavir / Ritonavir	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.
Test Group	Favipiravir	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.
Test Group	Hydroxychloroquine	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.
Control Group	Hydroxychloroquine	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.

Primary Outcome Measures

Name	Time	Method
Mortality	Up to 28 days	In-hospital mortality
Dyspnea	Up to 28 days	shortness of breath based on symptoms of Dyspnea and questioning the patient
long of hospitalization	Up to 28 days	long of hospitalization
Laboratory Treatment Response (Blood cell count)	Up to 28 days	Laboratory Treatment Response; return of blood cell count to normal
Laboratory Treatment Response (CRP )	Up to 28 days	Laboratory Treatment Response; return of CRP values to normal
Oxygen saturation without supplemental oxygen.	Up to 28 days	Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes.
Oxygen therapy	Up to 28 days	Oxygen therapy maximum flow during the day (lit/min)

Trial Locations

Locations (1)

Mohammad Sadegh Bagheri Baghdasht; 🇮🇷 Tehran, Iran, Islamic Republic of