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Completed

NCT Number: NCT04464408

Favipiravir Therapy in Adults With Mild COVID-19

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

King Fahad Hospital - Madinah, Al Madīnah, Saudi Arabia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients must be eligible according to the following criteria for enrollment

  • Should be at least 18 years of age
  • Male or non-pregnant female (pregnancy testing is not mandatory. If the patient requests or is not sure, the study team will provide it)
  • 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
  • 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:

  • Patients with concomitant documented bacterial pneumonia established through positive sputum cultures
  • Patients who are pregnant or breastfeeding
  • Known sensitivity/allergy to Favipiravir (If Faviparavir was used for COVID-19 in the patient previously for influenza)
  • 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

Treatment and study plan

Favipiravir

Drug

1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily

Placebo

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

King Abdullah International Medical Research Center

Other

Collaborators

  • Ministry of Health, Saudi Arabia

Registry information

Official study title

A Trial of Favipiravir Therapy in Adults With Mild Coronavirus Disease COVID-19

Acronym: Avi-Mild

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 9, 2020
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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