NCT04828564

Brief Summary

This is a national, multicenter, open-label, randomized, phase II/III trial that evaluates the efficacy and safety of favipiravir and ribavirin in the treatment of patients with confirmed COVID-19 observed within 72 hours. Approximately 100 patients will be randomized in 1:1 ratio and divided into two groups.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 2, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

April 1, 2021

Last Update Submit

April 1, 2021

Conditions

SARS-CoV2COVID-19

Outcome Measures

Primary Outcomes (1)

  • Hospitalized patient rates

    The number of hospitalized patients

    15 days

Secondary Outcomes (14)

  • Mortality rate

    15 days

  • Time from randomization to relief of symptoms

    15 days

  • Viral clearance

    15 days

  • Changes in angiotensin-converting enzyme 2 (ACE2) receptor levels

    15 days

  • Changes in transmembrane protease serine II (TMPRSS2) activity

    15 days

  • +9 more secondary outcomes

Study Arms (2)

Ribavirin Arm

EXPERIMENTAL

Ribavirin dosage: 200 mg oral ribavirin capsules for 5 days Regimen: 1200 mg loading dose on day-1 (three capsules in the morning and three capsules in the evening) followed by 800 mg/day maintenance dose (two capsules in the morning and two capsules in the evening) on day-2 to day-5.

Drug: Ribavirin Capsules

Favipiravir Arm

ACTIVE COMPARATOR

Favipiravir dosage: 200 mg oral favipiravir tablets for 5 days Regimen: 2x1600 mg loading dose on day-1 (eight tablets in the morning and eight tablets in the evening) followed by 2x600 mg maintenance dose (three tablets in the morning and three tablets in the evening) on day-2 to day-5.

Drug: Favipiravir

Interventions

Ribavirin CapsulesDRUG

Ribavirin 200 mg capsules

Ribavirin Arm
FavipiravirDRUG

Favipiravir 200 mg tablets

Favipiravir Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female or male patients aged 18 years and older infected with the SARS-CoV-2 virus.
  • Patients that have COVID-19 symptoms within 72 hours and have a positive PCR test result.
  • Patients in a stable clinical condition and referred as outpatient for COVID-19 infection.
  • Patients who sign the informed consent before the any study procedures.

You may not qualify if:

  • Patients who have required hospitalization.
  • Patients who have required intensive care.
  • Patients who do not sign the informed consent.
  • Any condition that in the investigator's judgement might interfere with study procedures or the ability of the patient to adhere to and complete the study.
  • Patients who have been participating in any other clinical trial.
  • Severe liver failure (Child Pugh score ≥ C, transaminase\>5 times the upper limit of normal (ULN).
  • Severe renal failure (GFR ≤30 mL/min/1.73 m2) or continuous dialysis (hemodialysis, peritoneal dialysis) or continuous renal replacement therapy.
  • Severe cardiac disease.
  • History of hypersensitivity to either ribavirin/favipiravir.
  • Pregnant or breast-feeding.
  • Patients who cannot use appropriate contraceptive method during and after the study.
  • Patients who are treated with any other treatment agent for COVID-19 in the last 90 days.
  • Patients who had COVID-19 vaccination.
  • Patients who had ribavirin/favipiravir for any reason in the past 72 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ankara University, School of Medicine

Ankara, Cebeci, 06590, Turkey (Türkiye)

Location

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Koc University Hospital

Istanbul, 34010, Turkey (Türkiye)

Location

Umraniye Training and Research Hospital

Istanbul, 34764, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

Ribavirinfavipiravir

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Alpay Azap, MD, Prof

CONTACT

+90 312 508 2681azap@medicine.ankara.edu.tr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof., MD.

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 2, 2021

Study Start

April 1, 2021

Primary Completion

September 30, 2021

Study Completion

December 31, 2021

Last Updated

April 2, 2021

Record last verified: 2021-04

Locations

TU(4)