Clinical trial NCT04464408: Favipiravir Therapy in Adults With Mild COVID-19
Official title: A Trial of Favipiravir Therapy in Adults With Mild Coronavirus Disease COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: COVID-19
Keywords: Favipiravir
COVID19
Mild illness
Saudi Arabia
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Saudi Arabia
First posted: 2020-07-09
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: PCR negative
timeFrame: 15 days
Secondary outcomes:
measure: Time from randomization to clinical recovery
timeFrame: 15 days
measure: Evaluate symptoms progression
timeFrame: 28 days
measure: Evaluate Faviparivirs effect
timeFrame: 15 days
measure: Evaluate Favipiravir's effect
timeFrame: 28 days
measure: Evaluate the safety of Favipiravir
timeFrame: 28 days
Other outcomes:
Locations:
city: Al Madinah
country: Saudi Arabia
facility: Prince Mohammed Bin Abdul Aziz Hospital - Al Madinah
city: Al Madīnah
country: Saudi Arabia
facility: King Fahad Hospital - Madinah
city: Al Madīnah
country: Saudi Arabia
facility: Primary Health Care-Safiyah
city: Mecca
country: Saudi Arabia
facility: King Abdullah Medical City - Makkah
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City - Riyadh
city: Riyadh
country: Saudi Arabia
facility: Primary Health Care-Al Mansoura
city: Riyadh
country: Saudi Arabia
facility: Primary Health Care-Al Urijah
Study officials:
affiliation: KAMC-RD, Ministry of National Guard Health Affairs (MNGHA), Saudi Arabia
name: Mohammad Bosaeed
role: PRINCIPAL_INVESTIGATOR
References:
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.