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Favipiravir Therapy in Adults With Mild COVID-19 (Avi-Mild)

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Favipiravir
Placebo
Sponsored by
King Abdullah International Medical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Favipiravir, COVID19, Mild illness, Saudi Arabia

Eligibility Criteria

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

Inclusion Criteria

Patients must be eligible according to the following criteria for enrollment

  1. Should be at least 18 years of age
  2. Male or non-pregnant female (pregnancy testing is not mandatory. If the patient requests or is not sure, the study team will provide it)
  3. Diagnosed with mild COVID-19* confirmed by positive PCR test for SARS-CoV-2 at the time of recruitment, a result within the last five days
  4. Patients have to be enrolled within 5 days of disease onset.

Exclusion criteria

Patients meeting any of the following criteria will be excluded from trial enrolment:

  1. Patients with concomitant documented bacterial pneumonia established through positive sputum cultures
  2. Patients who are pregnant or breastfeeding
  3. Known sensitivity/allergy to Favipiravir (If Faviparavir was used for COVID-19 in the patient previously for influenza)

  4. Major comorbidities increasing the risk of study drug including

    • Hematologic malignancy
    • Advanced (stage 4-5) chronic kidney disease or dialysis therapy
    • Severe liver damage (Child-Pugh score C, AST> 5 times the upper limit)
    • HIV
    • Gout/history of Gout or hyperuricemia (two times above the ULN)

(6) Having used Favipiravir or participated in any other interventional drug clinical study within 30 days before the first dose of study drug (i.e., the patient received it for influenza previously) (7) The investigator believes that participating in the trial is not in the best interests of the patient, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues) (8) Clinical prognostic non-survival, palliative care, or in a deep coma and have no response to supportive treatment within three hours of admission.

(9) Hospitalized patients for mild, moderate, or severe COVID-19

Sites / Locations

  • Prince Mohammed Bin Abdul Aziz Hospital - Al Madinah
  • King Fahad Hospital - Madinah
  • Primary Health Care-Safiyah
  • King Abdullah Medical City - Makkah
  • King Abdulaziz Medical City - Riyadh
  • Primary Health Care-Al Mansoura
  • Primary Health Care-Al Urijah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Favipiravir

Placebo

Arm Description

Favipiravir: 1800 mg (9 tablets) by mouth twice daily for one day, followed by 800mg (4 tablets) twice daily (Maximum days of therapy is 7 days)

9 tablets by mouth twice daily for one day, followed by 4 tablets twice daily (Maximum days of therapy is 7 days).

Outcomes

Primary Outcome Measures

PCR negative
Time from randomization to negativity in RT-PCR nucleic acid test for COVID-19 within 15 days of randomization

Secondary Outcome Measures

Time from randomization to clinical recovery
The duration from start of treatment (Favipiravir or placebo) to normalization of pyrexia, respiratory symptoms, and relief of cough (or other relevant symptoms at enrollment) that is maintained for at least 72 hours.
Evaluate symptoms progression
Evaluate symptoms severity and the disease course progression in both arms till 28 days after starting the medicine.
Evaluate Faviparivirs effect
To evaluate Favipiravir's effect on the requirement of the use of antipyretics, analgesics, or antibiotics within 15 days after starting medicine.
Evaluate Favipiravir's effect
To evaluate Favipiravir's effect on disease complications within 28 days after starting medicine (hospitalization, ICU admission, or Mechanical ventilation )
Evaluate the safety of Favipiravir
Evaluate the safety of investigational drug compared to the control arm within 15 days after starting the medicine. This is assessed by allergic reactions, medication intolerance, liver toxicity, and hyperuricemia in subjects

Full Information

First Posted
June 28, 2020
Last Updated
November 4, 2021
Sponsor
King Abdullah International Medical Research Center
Collaborators
Ministry of Health, Saudi Arabia
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1. Study Identification

Unique Protocol Identification Number
NCT04464408
Brief Title
Favipiravir Therapy in Adults With Mild COVID-19
Acronym
Avi-Mild
Official Title
A Trial of Favipiravir Therapy in Adults With Mild Coronavirus Disease COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 23, 2020 (Actual)
Primary Completion Date
August 4, 2021 (Actual)
Study Completion Date
August 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Abdullah International Medical Research Center
Collaborators
Ministry of Health, Saudi Arabia

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
Favipiravir is a selective and potent inhibitor of influenza viral RNA polymerase. It acts as a purine analogue, which selectively inhibits viral RNA-dependent RNA polymerase (RdRps). It has the characteristic of acting on RNA viruses including Ebola and Coronaviruses especially novel coronavirus (2019-nCoV). The purpose of this study is to evaluate the clinical efficacy and safety of Favipiravir in comparison to placebo in the treatment of mild COVID-19 cases. It is a Multicenter, randomized double-blinded, parallel-group trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Favipiravir, COVID19, Mild illness, Saudi Arabia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Favipiravir
Arm Type
Experimental
Arm Description
Favipiravir: 1800 mg (9 tablets) by mouth twice daily for one day, followed by 800mg (4 tablets) twice daily (Maximum days of therapy is 7 days)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
9 tablets by mouth twice daily for one day, followed by 4 tablets twice daily (Maximum days of therapy is 7 days).
Intervention Type
Drug
Intervention Name(s)
Favipiravir
Intervention Description
1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
(9 tablets) by mouth twice daily for one day, followed by (4 tablets) twice daily (Maximum days of therapy is 7 days)
Primary Outcome Measure Information:
Title
PCR negative
Description
Time from randomization to negativity in RT-PCR nucleic acid test for COVID-19 within 15 days of randomization
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Time from randomization to clinical recovery
Description
The duration from start of treatment (Favipiravir or placebo) to normalization of pyrexia, respiratory symptoms, and relief of cough (or other relevant symptoms at enrollment) that is maintained for at least 72 hours.
Time Frame
15 days
Title
Evaluate symptoms progression
Description
Evaluate symptoms severity and the disease course progression in both arms till 28 days after starting the medicine.
Time Frame
28 days
Title
Evaluate Faviparivirs effect
Description
To evaluate Favipiravir's effect on the requirement of the use of antipyretics, analgesics, or antibiotics within 15 days after starting medicine.
Time Frame
15 days
Title
Evaluate Favipiravir's effect
Description
To evaluate Favipiravir's effect on disease complications within 28 days after starting medicine (hospitalization, ICU admission, or Mechanical ventilation )
Time Frame
28 days
Title
Evaluate the safety of Favipiravir
Description
Evaluate the safety of investigational drug compared to the control arm within 15 days after starting the medicine. This is assessed by allergic reactions, medication intolerance, liver toxicity, and hyperuricemia in subjects
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must be eligible according to the following criteria for enrollment Should be at least 18 years of age Male or non-pregnant female (pregnancy testing is not mandatory. If the patient requests or is not sure, the study team will provide it) Diagnosed with mild COVID-19* confirmed by positive PCR test for SARS-CoV-2 at the time of recruitment, a result within the last five days Patients have to be enrolled within 5 days of disease onset. Exclusion criteria Patients meeting any of the following criteria will be excluded from trial enrolment: Patients with concomitant documented bacterial pneumonia established through positive sputum cultures Patients who are pregnant or breastfeeding Known sensitivity/allergy to Favipiravir (If Faviparavir was used for COVID-19 in the patient previously for influenza) Major comorbidities increasing the risk of study drug including Hematologic malignancy Advanced (stage 4-5) chronic kidney disease or dialysis therapy Severe liver damage (Child-Pugh score C, AST> 5 times the upper limit) HIV Gout/history of Gout or hyperuricemia (two times above the ULN) (6) Having used Favipiravir or participated in any other interventional drug clinical study within 30 days before the first dose of study drug (i.e., the patient received it for influenza previously) (7) The investigator believes that participating in the trial is not in the best interests of the patient, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues) (8) Clinical prognostic non-survival, palliative care, or in a deep coma and have no response to supportive treatment within three hours of admission. (9) Hospitalized patients for mild, moderate, or severe COVID-19
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Bosaeed
Organizational Affiliation
KAMC-RD, Ministry of National Guard Health Affairs (MNGHA), Saudi Arabia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince Mohammed Bin Abdul Aziz Hospital - Al Madinah
City
Al Madinah
Country
Saudi Arabia
Facility Name
King Fahad Hospital - Madinah
City
Al Madīnah
Country
Saudi Arabia
Facility Name
Primary Health Care-Safiyah
City
Al Madīnah
Country
Saudi Arabia
Facility Name
King Abdullah Medical City - Makkah
City
Mecca
Country
Saudi Arabia
Facility Name
King Abdulaziz Medical City - Riyadh
City
Riyadh
Country
Saudi Arabia
Facility Name
Primary Health Care-Al Mansoura
City
Riyadh
Country
Saudi Arabia
Facility Name
Primary Health Care-Al Urijah
City
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33853806
Citation
Bosaeed M, Alharbi A, Hussein M, Abalkhail M, Sultana K, Musattat A, Alqahtani H, Alshamrani M, Mahmoud E, Alothman A, Alsaedy A, Aldibasi O, Alhagan K, Asiri AM, AlJohani S, Al-Jeraisy M, Alaskar A. Multicentre randomised double-blinded placebo-controlled trial of favipiravir in adults with mild COVID-19. BMJ Open. 2021 Apr 14;11(4):e047495. doi: 10.1136/bmjopen-2020-047495.
Results Reference
derived

Learn more about this trial

Favipiravir Therapy in Adults With Mild COVID-19

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