NCT04351295

Brief Summary

Faviprevir in COVID-19 treatment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

April 20, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2020

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

April 15, 2020

Last Update Submit

October 29, 2021

Conditions

COVID

Outcome Measures

Primary Outcomes (1)

  • Number of patients with mortality or need for mechanical ventilation

    Number of patients with mortality or need for mechanical ventilation

    6 months

Study Arms (2)

Faviprevir

EXPERIMENTAL

Faviprevir

Drug: Favipiravir

chloroquine

ACTIVE COMPARATOR

chloroquine

Drug: Chloroquine

Interventions

FavipiravirDRUG

Favipiravir

Also known as: Faviprevir
Faviprevir
ChloroquineDRUG

chloroquine oral tablets

chloroquine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with covid 19

You may not qualify if:

  • Allergy or contraindications to faviprevir

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University, Ainshams University

Tanta, 35111, Egypt

Location

Related Publications (1)

  • Dabbous HM, Abd-Elsalam S, El-Sayed MH, Sherief AF, Ebeid FFS, El Ghafar MSA, Soliman S, Elbahnasawy M, Badawi R, Tageldin MA. Efficacy of favipiravir in COVID-19 treatment: a multi-center randomized study. Arch Virol. 2021 Mar;166(3):949-954. doi: 10.1007/s00705-021-04956-9. Epub 2021 Jan 25.

    PMID: 33492523DERIVED

MeSH Terms

Interventions

favipiravirChloroquine

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • sherief Abd-Elsalam, Ass. Prof.

    Tanta University - Faculty of Medicine

    PRINCIPAL INVESTIGATOR

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
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 17, 2020

Study Start

April 20, 2020

Primary Completion

September 28, 2020

Study Completion

September 28, 2020

Last Updated

November 1, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)