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

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: NCT04464408
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : March 5, 2021
Sponsor:
Collaborator:
Ministry of Health, Saudi Arabia
Information provided by (Responsible Party):
King Abdullah International Medical Research Center

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Favipiravir Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 576 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Trial of Favipiravir Therapy in Adults With Mild Coronavirus Disease COVID-19
Actual Study Start Date : July 23, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Favipiravir
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)
Drug: Favipiravir
1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily

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




Primary Outcome Measures :
  1. PCR negative [ Time Frame: 15 days ]
    Time from randomization to negativity in RT-PCR nucleic acid test for COVID-19 within 15 days of randomization


Secondary Outcome Measures :
  1. Time from randomization to clinical recovery [ Time Frame: 15 days ]
    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.

  2. Evaluate symptoms progression [ Time Frame: 28 days ]
    Evaluate symptoms severity and the disease course progression in both arms till 28 days after starting the medicine.

  3. Evaluate Faviparivirs effect [ Time Frame: 15 days ]
    To evaluate Favipiravir's effect on the requirement of the use of antipyretics, analgesics, or antibiotics within 15 days after starting medicine.

  4. Evaluate Favipiravir's effect [ Time Frame: 28 days ]
    To evaluate Favipiravir's effect on disease complications within 28 days after starting medicine (hospitalization, ICU admission, or Mechanical ventilation )

  5. Evaluate the safety of Favipiravir [ Time Frame: 28 days ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


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): NCT04464408


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

Locations
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Saudi Arabia
Prince Mohammed Bin Abdul Aziz Hospital - Al Madinah Recruiting
Al Madinah, Saudi Arabia
Contact: Zeid Jaafar         
King Fahad Hospital - Madinah Recruiting
Al Madīnah, Saudi Arabia
Contact: Sana Alrehaily         
Primary Health Care-Safiyah Recruiting
Al Madīnah, Saudi Arabia
Contact: Mohannad Bahlaq         
King Abdullah Medical City - Makkah Recruiting
Mecca, Saudi Arabia
Contact: Hanan Al-Turkistani         
King Abdulaziz Medical City - Riyadh Recruiting
Riyadh, Saudi Arabia
Contact: Mohammad Bosaeed         
Primary Health Care-Al Mansoura Active, not recruiting
Riyadh, Saudi Arabia
Primary Health Care-Al Urijah Recruiting
Riyadh, Saudi Arabia
Contact: Ali Tolba         
Sponsors and Collaborators
King Abdullah International Medical Research Center
Ministry of Health, Saudi Arabia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier: NCT04464408    
Other Study ID Numbers: RC 20/220/R
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021
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:
Favipiravir
COVID19
Mild illness
Saudi Arabia