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Efficacy and Safety of Favipiravir in Management of COVID-19 (FAV-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04349241
Recruitment Status : Not yet recruiting
First Posted : April 16, 2020
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Hany Dabbous, Ain Shams University

Brief Summary:
Randomized controlled interventional trial (Clinical Trial) phase 3 to assess the safety and efficacy of favipiravir versus the standard care therapy in the treatment of patients with COVID-19.

Condition or disease Intervention/treatment Phase
Coronavirus Disease (COVID-19) Drug: favipiravir Drug: Standard of care therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

A block-randomization scheme will be generated by computer software. 100 patients with confirmed COVID-19 will be randomized between favipiravir and the standard of care therapy (treated according to the national protocol) in a 1:1 ratio.

Group 1: 50 patients will receive the investigational drug favipiravir. Group 2: 50 patients will receive oseltamivir and hydroxychloroquine as the national standard of care therapy.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Favipiravir in Management of COVID-19
Estimated Study Start Date : April 20, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: favipiravir
favipiravir in a regimen of 3200 mg (1600 mg 12 hourly) loading dose on day-1 followed by 1200 mg maintenance dose (600 mg 12 hourly daily) on day-2 to day-10
Drug: favipiravir
pyrazine carboxamide derivative (6-fluoro-3-hydroxy-2-pyrazinecarboxamide), a new type of RNA-dependent RNA polymerase (RdRp) inhibitor
Other Name: pyrazine carboxamide derivative

Active Comparator: Standard of care therapy
oseltamivir 75 mg 12 hourly for 5-10 days and hydroxychloroquine 400mg 12 hourly day -1 followed by 200mg 12 hourly daily on day- 2 to day-5-10.
Drug: Standard of care therapy
oseltamivir 75 mg 12 hourly for 5-10 days and hydroxychloroquine 400mg 12 hourly day -1 followed by 200mg 12 hourly daily on day- 2 to day-5-10
Other Name: National Egyptian guideline




Primary Outcome Measures :
  1. Viral clearance [ Time Frame: 14 days ]
    Two successive negative COVID-19 PCR analysis tests 48-72 hours apart

  2. Clinical improvement [ Time Frame: 14 days ]
    Normal body temperature for 48 hours


Secondary Outcome Measures :
  1. Radiological Improvement [ Time Frame: 14 days ]
    Improvement of radiological abnormalities at day 14



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients aged between 18 and 80 years.

Patients with confirmed COVID-19 documented by a diagnostic laboratory test (e.g., nasopharyngeal swab) at the time of illness.

And Have mild to moderate symptoms according to the national protocol classification of patients.

Exclusion Criteria:

Patients have severe or immediately life-threatening COVID-19, Severe disease is defined as: dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours Life-threatening disease is defined as: respiratory failure, septic shock, and/or multiple organ dysfunction or failure

Pregnant or lactating females.

Participation in any investigational clinical study, other than observational, within the past 30 days; or plans to participate in such a study at any time from the day of enrollment until 30 days post-treatment in the current study.


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): NCT04349241


Contacts
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Contact: Hany Dabbous 01001798313 drhdabbous@gmail.com

Locations
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Egypt
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, Egypt, 11556
Contact: Fatma Soliman E Ebeid    01095569596    dr.fatma_ebeid@yahoo.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Hany Dabbous Ain Shams University
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Responsible Party: Hany Dabbous, Assistant professor of Faculty of Medicine, Ain Shams University
ClinicalTrials.gov Identifier: NCT04349241    
Other Study ID Numbers: FMASU P14 / 2020
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Pyrazinamide
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents