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

Primary Purpose

COVID-19, Favipiravir, Kaletra

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Favipiravir
Hydroxychloroquine
Lopinavir / Ritonavir
Sponsored by
Baqiyatallah Medical Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

16 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mohammad Sadegh Bagheri Baghdasht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 3, 2020
Last Updated
June 12, 2020
Sponsor
Baqiyatallah Medical Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT04376814
Brief Title
Favipiravir Plus Hydroxychloroquine and Lopinavir/Ritonavir Plus Hydroxychloroquine in COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 29, 2020 (Actual)
Primary Completion Date
April 5, 2020 (Actual)
Study Completion Date
May 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baqiyatallah Medical Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Favipiravir, Kaletra, Hydroxychloroquine, Lopinavir/Ritonavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Favipiravir
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lopinavir / Ritonavir
Other Intervention Name(s)
Kaletra
Intervention Description
Patients will be given 200/50 mg of Lopinavir / Ritonavir two times per day for seven days.
Primary Outcome Measure Information:
Title
Mortality
Description
In-hospital mortality
Time Frame
Up to 28 days
Title
long of hospitalization
Description
long of hospitalization
Time Frame
Up to 28 days
Title
Laboratory Treatment Response (Blood cell count)
Description
Laboratory Treatment Response; return of blood cell count to normal
Time Frame
Up to 28 days
Title
Laboratory Treatment Response (CRP )
Description
Laboratory Treatment Response; return of CRP values to normal
Time Frame
Up to 28 days
Title
Dyspnea
Description
shortness of breath based on symptoms of Dyspnea and questioning the patient
Time Frame
Up to 28 days
Title
Oxygen saturation without supplemental oxygen.
Description
Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes.
Time Frame
Up to 28 days
Title
Oxygen therapy
Description
Oxygen therapy maximum flow during the day (lit/min)
Time Frame
Up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Mohammad Sadegh Bagheri Baghdasht
City
Tehran
ZIP/Postal Code
0
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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