Favipiravir in Hospitalized COVID-19 Patients (FIC)

April 26, 2020 updated by: Seyed Sina Naghibi Irvani, MD, MPH, MBA, Senior Researcher., Shahid Beheshti University of Medical Sciences

Efficacy and Safety of Favipiravir Compared to the Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized, Controlled, Double-Blind, Clinical Trial

The present study is a randomized, double-blind, controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Favipiravir, previously known as T-705, is a prodrug of a purine nucleotide, favipiravir ribofuranosyl-5'-triphosphate. The active agent inhibits the RNA polymerase, halting viral replication. Most of favipiravir's preclinical data are derived from its influenza and Ebola activity; however, the agent also demonstrated broad activity against other RNA viruses. In vitro, the 50% effective concentration (EC50) of favipiravir against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was 61.88 μM/L in Vero E6 cells.

Limited clinical experience has been reported supporting the use of favipiravir for COVID-19. In a prospective, randomized, multicenter study, favipiravir (n = 120) was compared with Arbidol (n = 120) for the treatment of moderate and severe COVID-19 infections. Differences in clinical recovery at day 7 were observed in patients with moderate infections (71.4% favipiravir and 55.9% Arbidol, P = .019). No significant differences were observed in the severe or severe and moderate (combined) arms.73 These data support further investigation with randomized clinical trials (RCTs) of the efficacy of favipiravir for the treatment of COVID-19.

Chloroquine has been a broadly-utilized anti-malaria agent which back in 2006, had been proved to be a powerful wide-spectrum antiviral. Moreover, Chloroquine has the characteristics of anti-inflammatory and immune-modulatory by inhibiting the production of tumor necrosis factor alpha (TNF-α) along with interleukin 6 (IL-6). In the first half of February, a study illustrated puissant inhibition of SARS-CoV-2 by Chloroquine, when taking two 500-mg tablets of it by mouth per day; similar to some clinical studies in China through this outbreak. According to the news briefing of a study, it was indicated that chloroquine phosphate actually outdo the control treatment in inhibition of pneumonia exacerbation, improving lung imaging findings, and curtailing the disease course. Another study evaluated the possible doses of chloroquine (CQ) and hydroxychloroquine (HCQ) to find the optimized dose in treatment of COVID-19. They revealed that while within in-vitro settings Hydroxychloroquine is more potent than chloroquine. As a conclusion, they suggested a 800 mg daily dose of hydroxychloroquine, followed by an overall maintenance dose of 400 mg per day divided in two separate doses, which was three-fold more potent compared to the 500 mg twice daily administration of chloroquine in 5 days. The new study published in 16th March, pointed out that hydroxychloroquine was notably effectual in eradicating SARS-CoV-2 from the nasopharynx. Currently the evidence is quite inconclusive about the effectiveness or comparative effectiveness of either HCQ or CQ. Moreover, CQ has recently become scarce and even unavailable for ordering due to a huge demand for it, all because of a significant interest gained as a potential medicinal alternative for the management of COVID-19. In spite of all, the primary experience in China and France is propitious for the potential role of chloroquine, or alternatively hydroxychloroquine, for managing COVID-19.

The present study is a randomized, double-blind, controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences and Health Services
        • Contact:
          • Seyed Sina Naghibi Irvani, MD, MPH, MBA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18
  • COVID-19 Confirmed Cases (Reverse transcription polymerase chain reaction (RT-PCR) Confirmed).
  • Tympanic Temperature of ≥37.5 AND at least one of the following: Cough, Sputum production, nasal discharge, myalgia, headache or fatigue) on admission.
  • Time of onset of the symptoms should be acute ( Days ≤ 10).
  • SpO2 ≤ 93%
  • Respiratory Rate ≥ 22

Exclusion Criteria:

  • Refusal to participate expressed by patient or legally authorized representative if they are present.
  • Patients with prolonged QT or PR intervals, Second or Third Degree heart block and Arrhythmias.
  • Patients using drugs with potential interaction with Favipiravir or Hydroxychloroquine.
  • Pregnant or lactating women.
  • History of alcohol or drug addiction in the past 5 years.
  • Blood Alanine transaminase/aspartate aminotransferase (ALT/AST) levels > 5 times the upper limit of normal on laboratory results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Drug: Hydroxychloroquine
This Drug will be used in all arms as mandated by our governmental guidelines.
Experimental: Favipiravir
Drug: Favipiravir
This will be drug only used in the intervention arm of our study, designed mainly to assess the additional efficacy and safety of Favipiravir in COVID-19 patients.
Drug: Hydroxychloroquine
This Drug will be used in all arms as mandated by our governmental guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to clinical improvement
Time Frame: From date of randomization until 14 days later.
Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.
From date of randomization until 14 days later.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: From date of randomization until 14 days later.
If the patient dies, we have reached an outcome.
From date of randomization until 14 days later.
Duration of hospitalization
Time Frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days.
Duration of hospitalization (days)
From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days.
Cumulative incidence of serious adverse events
Time Frame: Days 1, 2, 3, 4, 5, 6, 7 and 14.
With incidence of any serious adverse effects, the outcome has happened.
Days 1, 2, 3, 4, 5, 6, 7 and 14.
oxygen saturation by pulse oximetry (SpO2) Improvement
Time Frame: Days 1, 2, 3, 4, 5, 6, 7 and 14.
Pulse-oxymetry
Days 1, 2, 3, 4, 5, 6, 7 and 14.
Incidence of new mechanical ventilation use
Time Frame: From date of randomization until 14 days later.
Incidence of new mechanical ventilation use
From date of randomization until 14 days later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Study Chair: Mohammad Fathi, MD, Shahid Beheshti University of Medical Sciences
  • Study Director: Sasan Tavana, MD, Shahid Beheshti University of Medical Sciences
  • Principal Investigator: Nasser Malekpour Alamdari, MD, Shahid Beheshti University of Medical Sciences
  • Principal Investigator: Mehran Lack, MD, Shahid Beheshti University of Medical Sciences
  • Principal Investigator: Nader Markazi, MD, Shahid Beheshti University of Medical Sciences
  • Principal Investigator: Sanaz Zargar Balaye Jam, MD, Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 20, 2020

Primary Completion (Anticipated)

May 3, 2020

Study Completion (Anticipated)

May 5, 2020

Study Registration Dates

First Submitted

April 18, 2020

First Submitted That Met QC Criteria

April 20, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 26, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Favipiravir in COVID-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

There is no further information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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