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

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ClinicalTrials.gov Identifier: NCT04376814
Recruitment Status : Enrolling by invitation
First Posted : May 6, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Mohammad Sadegh Bagheri Baghdasht, Baqiyatallah Medical Sciences University

Study Description
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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.


Condition or disease Intervention/treatment Phase
COVID-19 Favipiravir Kaletra Hydroxychloroquine Lopinavir/Ritonavir Drug: Favipiravir Drug: Hydroxychloroquine Drug: Lopinavir / Ritonavir Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 29, 2020
Actual Primary Completion Date : April 5, 2020
Estimated Study Completion Date : May 25, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Kaletra


Outcome Measures
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Primary Outcome Measures :
  1. Mortality [ Time Frame: Up to 28 days ]
    In-hospital mortality

  2. long of hospitalization [ Time Frame: Up to 28 days ]
    long of hospitalization

  3. Laboratory Treatment Response (Blood cell count) [ Time Frame: Up to 28 days ]
    Laboratory Treatment Response; return of blood cell count to normal

  4. Laboratory Treatment Response (CRP ) [ Time Frame: Up to 28 days ]
    Laboratory Treatment Response; return of CRP values to normal

  5. Dyspnea [ Time Frame: Up to 28 days ]
    shortness of breath based on symptoms of Dyspnea and questioning the patient

  6. Oxygen saturation without supplemental oxygen. [ Time Frame: Up to 28 days ]
    Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes.

  7. Oxygen therapy [ Time Frame: Up to 28 days ]
    Oxygen therapy maximum flow during the day (lit/min)


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04376814


Locations
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Iran, Islamic Republic of
Mohammad Sadegh Bagheri Baghdasht
Tehran, Iran, Islamic Republic of, 0
Sponsors and Collaborators
Baqiyatallah Medical Sciences University
More Information
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Responsible Party: Mohammad Sadegh Bagheri Baghdasht, Principal Investigator, Baqiyatallah Medical Sciences University
ClinicalTrials.gov Identifier: NCT04376814    
Other Study ID Numbers: IR.BMSU.REC.1399.017
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ritonavir
Lopinavir
Hydroxychloroquine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
 Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Antirheumatic Agents