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FAvipiravir and HydroxyChloroquine Combination Therapy (FACCT)

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ClinicalTrials.gov Identifier: NCT04392973
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
King Abdullah International Medical Research Center

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.

Condition or disease Intervention/treatment Phase
COVID19 Combination Product: Favipiravir and Hydroxychloroquine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, open-label, parallel groups were participants are assigned to either an intervention arm or standard of care.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial of Favipiravir and Hydroxychloroquine Combination in Adults Hospitalized With Moderate and Severe Covid-19
Actual Study Start Date : May 21, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Combination therapy Favipiravir (10 days) + Hydroxychloroquine(5 days)
Combination Product: Favipiravir and Hydroxychloroquine

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.

Other Name: Avigan

No Intervention: Control
Standard of Care Treatment for COVID-19 Infection



Primary Outcome Measures :
  1. Clinical Improvement [ Time Frame: 28 days ]
    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 :
  1. Viral shedding [ Time Frame: 28 days ]
    PCR test negative conversion days from positive to negative.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.

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): NCT04392973


Contacts
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Contact: Mohammad Bosaeed +966(11)8011111 dr.bosaeed@live.com
Contact: Majed Al Jeraisy +96611 8494455 ext 94455 JeraisyM@NGHA.MED.SA

Locations
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Saudi Arabia
King Abdulaziz Hospital Not yet recruiting
Hasa, Eastern Region, Saudi Arabia, 31982
AlMadina General Hospital Not yet recruiting
Al Madīnah, Saudi Arabia
King Abdulaziz Medical City Not yet recruiting
Jeddah, Saudi Arabia
King Abdulaziz Hospital Not yet recruiting
Mecca, Saudi Arabia
King Abdulaziz Medical City, National Guard Health Affairs Recruiting
Riyadh, Saudi Arabia, 11426
Contact: Mohammad Bosaeed, MD         
Imam Abdulrahman Alfaisal Hospital Not yet recruiting
Riyadh, Saudi Arabia
Sponsors and Collaborators
King Abdullah International Medical Research Center
Investigators
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Study Director: Ahmad Alaskar KAIMRC
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Responsible Party: King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier: NCT04392973    
Other Study ID Numbers: RC20/174
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 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
Keywords provided by King Abdullah International Medical Research Center:
SARS-CoV-2
Additional relevant MeSH terms:
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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents