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Completed

NCT Number: NCT04818320

Favipiravir in High-risk COVID-19 Patients

The study aims to investigate the efficacy of favipiravir in high-risk COVID-19 patients. The study population includes symptomatic mild-to-moderate COVID-19 inpatients, within first 7 days of illness, who are 50 years old and above, and have 1 or more comorbidities. The study is designed as a randomised, open-label, multicenter clinical trial where the patients are randomised 1:1 to groups receiving favipiravir (5 days) versus no favipiravir.

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Key information

Conditions

Covid19 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

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Penang General Hospital

George Town, Pulau Pinang, 10450, Malaysia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients are eligible to be included in the study only if they fulfil ALL the following criteria:
  • RT-PCR confirmed COVID-19 cases
  • Aged 50 years and above, AND have one or more co-morbidities
  • Within the first 7 days of illness (from symptom onset)
  • Mild to moderate clinical severity

Exclusion criteria

  • Asymptomatic stage 1 patients
  • Patients with SpO2 less than 95% without oxygen therapy
  • Patients who needs oxygen supplements
  • Patients with concomitant bacterial or fungal infection (confirmed by culture) prior to initiation of study
  • Patients with congestive heart failure
  • Patients with severe hepatic impairment (>Grade 3: ALT >10 times of upper normal limit)
  • Impaired kidney function (creatinine clearance according to Cockcroft-Gault formula less than 30 ml/min) at the time of screening.
  • Malabsorption syndrome or other clinically significant gastrointestinal disease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others).
  • Pregnant or nursing women or women planning pregnancy.
  • Female patients who cannot consent to contraceptive use of oral contraceptives, mechanical contraceptives such as intrauterine devices or barrier devices (pessaries, condoms), or a combination of these devices from the start of favipiravir administration to 7 days after the end of favipiravir administration
  • Male patients whose partner cannot agree to use the contraception method described in (9)
  • Patients with a history of gout or on treatment for gout or hyperuricemia
  • Patients receiving immunosuppressants
  • Patients who received interferon or drugs with reported antiviral activity against COVID-19 (hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination) within 7 days of illness.
  • Patients in whom this episode of infection is a recurrence or reinfection of COVID-19 infection
  • Patients who have previously received favipiravir
  • Patients who are not able to provide written consent by themselves
  • Other patients judged ineligible by the principal investigator or sub-investigator

Treatment and study plan

Favipiravir

Drug

Day 1: 1800mg BD, day 2-5: 800mg BD

Primary outcomes

  1. Need for oxygen supplement

    Time frame: Day of discharge/day 28 of treatment (if still hospitalized)

    Drop in SPO2 in room air to <95% or requiring supplemental oxygen to maintain SPO2≥95%

Secondary outcomes

  1. Difference in the number of patients admitted to ICU

    Time frame: Day of discharge/day 28 of treatment (if still hospitalized)

  2. Difference in the number of patients requiring mechanical ventilation

    Time frame: Day of discharge/day 28 of treatment (if still hospitalized)

  3. Changes in the length of ICU stay

    Time frame: Day of discharge/day 28 of treatment (if still hospitalized)

  4. Changes in in-hospital mortality rate

    Time frame: Day of discharge/day 28 of treatment (if still hospitalized)

Sponsors and collaborators

Lead sponsor

Penang Hospital, Malaysia

Other Gov

Collaborators

  • Enche' Besar Hajjah Khalsom Hospital
  • Hospital Sultanah Nur Zahirah, Kuala Terengganu
  • Hulu Terrengganu Hospital
  • Institute for Clinical Research
  • Jasin Hospital
  • Kepala Batas Hospital
  • Melaka Hospital
  • Permai Hospital
  • Raja Perempuan Zainab II Hospital
  • Raja Permaisuri Bainun Hospital
  • Sultanah Aminah Hospital
  • Sungai Buloh Hospital
  • Tampin Hospital
  • Tawau Hospital
  • Tengku Ampuan Afzan Hospital
  • The Queen Elizabeth Hospital
  • Tuanku Fauziah Hospital
  • Tuanku Jaafar Hospital
  • Tumpat Hospital

Registry information

Official study title

Efficacy of Favipiravir in High Risk COVID-19 Patients: A Randomised, Open-label, Multicenter Clinical Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 26, 2021
Registry last updated
Nov 24, 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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