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Favipiravir in High-risk COVID-19 Patients

Primary Purpose

Covid19

Status

Completed

Phase

Phase 3

Locations

Malaysia

Study Type

Interventional

Intervention

Favipiravir

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Penang General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Favipiravir

Control

Arm Description

Favipiravir treatment group (with standard of care),

No favipiravir given. Standard of care only

Outcomes

Primary Outcome Measures

Need for oxygen supplement

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

Secondary Outcome Measures

Difference in the number of patients admitted to ICU

Difference in the number of patients requiring mechanical ventilation

Changes in the length of ICU stay

Changes in in-hospital mortality rate

Full Information

NCT ID

NCT04818320

First Posted

March 24, 2021

Last Updated

November 15, 2021

Sponsor

Penang Hospital, Malaysia

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04818320

Brief Title

Favipiravir in High-risk COVID-19 Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

February 16, 2021 (Actual)

Primary Completion Date

July 1, 2021 (Actual)

Study Completion Date

July 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Penang Hospital, Malaysia

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

500 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Favipiravir

Arm Type

Experimental

Arm Description

Favipiravir treatment group (with standard of care),

Arm Title

Control

Arm Type

No Intervention

Arm Description

No favipiravir given. Standard of care only

Intervention Type

Drug

Intervention Name(s)

Favipiravir

Intervention Description

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

Primary Outcome Measure Information:

Title

Need for oxygen supplement

Description

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

Time Frame