FAvipiravir and HydroxyChloroquine Combination Therapy

NCT04392973 | Completed DMC

• 1 other identifier: RC20/174
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 8

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.

Conditions

COVID19

Keywords

SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days

Secondary Outcomes (1)

• Viral shedding

  28 days

Study Arms (2)

Intervention

EXPERIMENTAL

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

Combination Product: Favipiravir and Hydroxychloroquine

Control

NO INTERVENTION

Standard of Care Treatment for COVID-19 Infection

Interventions

Favipiravir and Hydroxychloroquine COMBINATION_PRODUCT

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.

Also known as: Avigan

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead

Study Sites (8)

King Abdulaziz Hospital - Al Ahsa

Hasa, Eastern Province, Saudi Arabia

Location

AlMadina General Hospital

Al Madīnah, Saudi Arabia

Location

Al-Qatif Central Hospital

Al Qaţīf, Saudi Arabia

Location

Imam Abdulrahman Al Faisal Hospital - Dammam

Dammam, Saudi Arabia

Location

King Abdulaziz Medical City

Jeddah, Saudi Arabia

Location

King Abdulaziz Hospital - Makkah

Mecca, Saudi Arabia

Location

King Abdulaziz Medical City, National Guard Health Affairs

Riyadh, 11426, Saudi Arabia

Location

Imam Abdulrahman Alfaisal Hospital

Riyadh, Saudi Arabia

Location

Related Publications (2)

• 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.

  PMID: 34319552 DERIVED

• 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.

  PMID: 33129363 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

favipiravir; Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ahmad Alaskar

  KAIMRC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, open-label, parallel groups were participants are assigned to either an intervention arm or standard of care.

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 19, 2020
• Study Start: May 21, 2020
• Primary Completion: January 26, 2021
• Study Completion: April 26, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (8)