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FAvipiravir and HydroxyChloroquine Combination Therapy (FACCT)

Primary Purpose

COVID19

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Favipiravir and Hydroxychloroquine
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 COVID19 focused on measuring SARS-CoV-2

Eligibility Criteria

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

Inclusion Criteria:

  1. Should be at least 18 years of age
  2. Male or nonpregnant female,
  3. Diagnosed with COVID-19 by PCR confirmed SARS-coV-2 viral infection.
  4. Able to sign the consent form and agree to clinical samples collection (or their legal surrogates if subjects are or become unable to make informed decisions).
  5. Moderate or Severe COVID-19, defined as oxygen saturation (Sao2) of 94% or less while they were breathing ambient air or significant clinical symptoms with Chest X ray changes that require hospital admission.
  6. patients had to be enrolled within 10 days of disease onset

Exclusion Criteria:

  1. Patients who are pregnant or breastfeeding.
  2. Will be transferred to a non-study site hospital or expected to be discharged within 72 hours.
  3. Known sensitivity/allergy to hydroxychloroquine or Favipiravir
  4. Current use of hydroxychloroquine for another indication
  5. Prior diagnosis of retinopathy
  6. Prior diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency
  7. Major comorbidities increasing the risk of study drug including: i. Hematologic malignancy, ii. Advanced (stage 4-5) chronic kidney disease or dialysis therapy, iii. Known history of ventricular arrhythmias, iv. Current use of drugs that prolong the QT interval, Severe liver damage (Child-Pugh score ≥ C, AST> 5 times the upper limit), HIV.
  8. 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).
  9. Clinical prognostic non-survival, palliative care, or in deep coma and no have response to supportive treatment within three hours of admission.
  10. Patient with irregular rhythm
  11. Patient with a history of heart attack (myocardial infarction)
  12. Patient with a family history of sudden death from heart attack before the age of 50
  13. Take other drugs that can cause prolonged QT interval
  14. Patient who is receiving immunosuppressive therapy (cyclosporin) which cannot be switched to another agent or adjusted while using the investigational drug
  15. Gout/history of Gout or hyperuricemia (above the ULN), hereditary xanthinuria or xanthine calculi of the urinary tract.

Sites / Locations

  • King Abdulaziz Hospital - Al Ahsa
  • AlMadina General Hospital
  • Al-Qatif Central Hospital
  • Imam Abdulrahman Al Faisal Hospital - Dammam
  • King Abdulaziz Medical City
  • King Abdulaziz Hospital - Makkah
  • King Abdulaziz Medical City, National Guard Health Affairs
  • Imam Abdulrahman Alfaisal Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Combination therapy Favipiravir (10 days) + Hydroxychloroquine(5 days)

Standard of Care Treatment for COVID-19 Infection

Outcomes

Primary Outcome Measures

Clinical Improvement
The primary endpoint is the time to clinical improvement, defined as the time from the randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first.

Secondary Outcome Measures

Viral shedding
PCR test negative conversion days from positive to negative.

Full Information

First Posted
May 10, 2020
Last Updated
August 19, 2021
Sponsor
King Abdullah International Medical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT04392973
Brief Title
FAvipiravir and HydroxyChloroquine Combination Therapy
Acronym
FACCT
Official Title
A Trial of Favipiravir and Hydroxychloroquine Combination in Adults Hospitalized With Moderate and Severe Covid-19
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 21, 2020 (Actual)
Primary Completion Date
January 26, 2021 (Actual)
Study Completion Date
April 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Abdullah International Medical Research Center

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 study is a randomized, open-label, parallel groups multi-centered trial were participants are assigned to either an intervention arm ( a combination of Favipiravir and Hydroxychloroquin) or standard of care.
Detailed Description
In this trial, the investigators want to evaluate the efficacy of the combination of Favipiravir and Hydroxychloroquine as potential therapy for moderate and severe cases with COVID -19. Favipiravir which is a new type of RNA-dependent RNA polymerase (RdRp) inhibitor has activity against influenza virus, and Hydroxychloroquine, an analogue of chloroquine, has a clinical safety profile better than that of chloroquine and allows higher daily dose, Chloroquine is a widely used antimalarial that was found to be a potential broad-spectrum antiviral. There is an urgent need to explore therapeutic options for SARS-CoV-2 in order to face the pandemic. The selected combination was based on limited evidence clinically and in vitro on the efficacy of the Favipiravir and Hydroxychloroquine in SARS-CoV-2. The two medications were listed in many guidelines as treatment options and ongoing trials assessing their efficacy and safety. Thus, the investigators want to prove the effectiveness of the combination as therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19
Keywords
SARS-CoV-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, open-label, parallel groups were participants are assigned to either an intervention arm or standard of care.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Combination therapy Favipiravir (10 days) + Hydroxychloroquine(5 days)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of Care Treatment for COVID-19 Infection
Intervention Type
Combination Product
Intervention Name(s)
Favipiravir and Hydroxychloroquine
Other Intervention Name(s)
Avigan
Intervention Description
Route of Administration: Oral (or through Nasogastric tube) Dose: Favipiravir: Administer 1800 mg (9 tablets) by mouth twice daily for one day, followed by 800mg (4 tablets) twice daily (total days of therapy is 10 days or till hospital discharge) Hydroxychloroquine (400mg) twice daily on day 1; for days 2-5 (200mg) twice daily.
Primary Outcome Measure Information:
Title
Clinical Improvement
Description
The primary endpoint is the time to clinical improvement, defined as the time from the randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Viral shedding
Description
PCR test negative conversion days from positive to negative.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Should be at least 18 years of age Male or nonpregnant female, Diagnosed with COVID-19 by PCR confirmed SARS-coV-2 viral infection. Able to sign the consent form and agree to clinical samples collection (or their legal surrogates if subjects are or become unable to make informed decisions). Moderate or Severe COVID-19, defined as oxygen saturation (Sao2) of 94% or less while they were breathing ambient air or significant clinical symptoms with Chest X ray changes that require hospital admission. patients had to be enrolled within 10 days of disease onset Exclusion Criteria: Patients who are pregnant or breastfeeding. Will be transferred to a non-study site hospital or expected to be discharged within 72 hours. Known sensitivity/allergy to hydroxychloroquine or Favipiravir Current use of hydroxychloroquine for another indication Prior diagnosis of retinopathy Prior diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency Major comorbidities increasing the risk of study drug including: i. Hematologic malignancy, ii. Advanced (stage 4-5) chronic kidney disease or dialysis therapy, iii. Known history of ventricular arrhythmias, iv. Current use of drugs that prolong the QT interval, Severe liver damage (Child-Pugh score ≥ C, AST> 5 times the upper limit), HIV. 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). Clinical prognostic non-survival, palliative care, or in deep coma and no have response to supportive treatment within three hours of admission. Patient with irregular rhythm Patient with a history of heart attack (myocardial infarction) Patient with a family history of sudden death from heart attack before the age of 50 Take other drugs that can cause prolonged QT interval Patient who is receiving immunosuppressive therapy (cyclosporin) which cannot be switched to another agent or adjusted while using the investigational drug Gout/history of Gout or hyperuricemia (above the ULN), hereditary xanthinuria or xanthine calculi of the urinary tract.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmad Alaskar
Organizational Affiliation
KAIMRC
Official's Role
Study Director
Facility Information:
Facility Name
King Abdulaziz Hospital - Al Ahsa
City
Hasa
State/Province
Eastern Region
Country
Saudi Arabia
Facility Name
AlMadina General Hospital
City
Al Madīnah
Country
Saudi Arabia
Facility Name
Al-Qatif Central Hospital
City
Al-Qatif
Country
Saudi Arabia
Facility Name
Imam Abdulrahman Al Faisal Hospital - Dammam
City
Dammam
Country
Saudi Arabia
Facility Name
King Abdulaziz Medical City
City
Jeddah
Country
Saudi Arabia
Facility Name
King Abdulaziz Hospital - Makkah
City
Mecca
Country
Saudi Arabia
Facility Name
King Abdulaziz Medical City, National Guard Health Affairs
City
Riyadh
ZIP/Postal Code
11426
Country
Saudi Arabia
Facility Name
Imam Abdulrahman Alfaisal Hospital
City
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34319552
Citation
Bosaeed M, Mahmoud E, Alharbi A, Altayib H, Albayat H, Alharbi F, Ghalilah K, Al Arfaj A, AlJishi J, Alarfaj A, Alqahtani H, Almutairi BM, Almaghaslah M, Alyahya NM, Bawazir A, AlEisa S, Alsaedy A, Bouchama A, Alharbi M, AlShamrani M, Al Johani S, Aljeraisy M, Alzahrani M, Althaqafi AO, Almarhabi H, Alotaibi A, Alqahtani N, Arabi YM, Aldibasi OS, Alaskar A. Favipiravir and Hydroxychloroquine Combination Therapy in Patients with Moderate to Severe COVID-19 (FACCT Trial): An Open-Label, Multicenter, Randomized, Controlled Trial. Infect Dis Ther. 2021 Dec;10(4):2291-2307. doi: 10.1007/s40121-021-00496-6. Epub 2021 Jul 28.
Results Reference
derived
PubMed Identifier
33129363
Citation
Bosaeed M, Mahmoud E, Hussein M, Alharbi A, Alsaedy A, Alothman A, Aljeraisy M, Alqahtani H, Nashabat M, Almutairi B, Almaghaslah M, Aldibasi O, AlJohani S, Bouchama A, Arabi Y, Alaskar A. A Trial of Favipiravir and Hydroxychloroquine combination in Adults Hospitalized with moderate and severe Covid-19: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Oct 31;21(1):904. doi: 10.1186/s13063-020-04825-x.
Results Reference
derived

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FAvipiravir and HydroxyChloroquine Combination Therapy

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