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

NCT04376814 | Completed DMC

• 1 other identifier: IR.BMSU.REC.1399.017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Test Group

EXPERIMENTAL

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; Drug: Hydroxychloroquine

Control Group

ACTIVE COMPARATOR

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; Drug: Lopinavir / Ritonavir

Interventions

Favipiravir DRUG

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

Test Group

Hydroxychloroquine DRUG

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.

Control Group; Test Group

Lopinavir / Ritonavir DRUG

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

Also known as: Kaletra

Control Group

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Receiving other antiviral medications such as (Kaletra, Ribavirin, Oseltamivir)
• Chronic liver or renal failure
• HIV; GI bleeding
• Pregnancy
• Lactation
• QT interval \> 500 ms.

Sponsors & Collaborators

• Baqiyatallah Medical Sciences University: lead

Study Sites (1)

Mohammad Sadegh Bagheri Baghdasht

Tehran, 0, Iran

Location

MeSH Terms

Conditions

COVID-19

Interventions

favipiravir; Hydroxychloroquine; Lopinavir; lopinavir-ritonavir drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: May 6, 2020
• Study Start: March 29, 2020
• Primary Completion: April 5, 2020
• Study Completion: May 25, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-05

Locations

IR (1)