NCT04474457

Brief Summary

This study is an observational study (Non-interventional study) to evaluate the safety and efficacy of favipiravir in patients older than 15 years of age, diagnosed with COVID-19 and initiated treatment with favipiravir before enrollment to the study. Patients who have already had a routine favipiravir treatment decision or alternatively favipiravir treatment started at the time of enrollment, will be included in this study.

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 11, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 15, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

July 15, 2020

Last Update Submit

January 29, 2021

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

  • Time to recovery (discharge)

    The evaluation of the recovery discharge until the 7th day of hospitalization after the initiation of treatment.

    7 days

  • Decrease in viral load

    The evaluation of decrease in viral load until 7th day hospitalization after the initiation of treatment.

    7 days

Secondary Outcomes (13)

  • Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment

    7 days

  • Frequency of occurrence of lymphopenia from baseline

    7 days

  • Frequency of occurrence of thrombocytopenia from baseline

    7 days

  • Changes in alanine aminotransferase (ALT) levels from baseline

    7 days

  • Changes in aspartate aminotransferase (AST) levels from baseline

    7 days

  • +8 more secondary outcomes

Study Arms (1)

COVID-19/Favipiravir

Turkish patient cohort diagnosed with COVID-19 and previously initiated treatment with "Favipiravir".

Drug: Favipiravir

Interventions

FavipiravirDRUG

Turkish patient cohort diagnosed with COVID-19 and previously initiated treatment with "Favipiravir".

COVID-19/Favipiravir

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1000 patients aged 15 years or older and diagnosed with COVID-19 who meet inclusion/exclusion criteria of the study and have decision of treatment with favipiravir .

You may qualify if:

  • Male and female patients, diagnosed with Covid-19 disease who are 15 years of age or older at the time of enrollment
  • Patients who have understood all study procedures that will be applied under the study protocol
  • Patients with confirmed diagnosis of COVID-19 by PCR and/or other accepted methods and have a treatment decision with favipiravir
  • Patients who will accept oropharyngeal sample and venous blood sample collection periodically within the scope of the study protocol

You may not qualify if:

  • Patients who are pregnant or females who are breast feeding
  • Patients under the age of 15

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, School of Medicine

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

favipiravir

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

July 15, 2020

First Posted

July 16, 2020

Study Start

June 11, 2020

Primary Completion

December 31, 2020

Study Completion

June 1, 2021

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

TU(1)