NCT04460443

Brief Summary

Sofosbuvir containing treatment in treatment of COVID 19 Egyptian patients

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
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

July 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

July 4, 2020

Last Update Submit

December 3, 2020

Conditions

COVID

Outcome Measures

Primary Outcomes (1)

  • Number of patients with response to treatment

    The total number of patients with response to treatment

    1 month

Study Arms (3)

Sofosbuvir and ledipsavir

EXPERIMENTAL

Sofosbuvir and ledipsavir plus standard of care treatment.

Drug: Sofosbuvir ledipsavir

Sofosbuvir and Daklatasuvir

EXPERIMENTAL

Sofosbuvir and Daklatasuvir plus standard of card treatment..

Drug: sofosbuvirDrug: Daclatasvir

Standard treatment

NO INTERVENTION

Standard treatment alone

Interventions

sofosbuvirDRUG

Sofosbuvir once daily

Also known as: Mpiviropack, Sovaldy, soflanork
Sofosbuvir and Daklatasuvir
Sofosbuvir ledipsavirDRUG

Sofosbuvir ledipsavir once daily

Also known as: mpiviropack plus
Sofosbuvir and ledipsavir
DaclatasvirDRUG

Daklatasuvir tablets

Also known as: daklinza
Sofosbuvir and Daklatasuvir

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Covid positive patients.

You may not qualify if:

  • Contraindication to sofosbuvir or ribavirin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

MeSH Terms

Interventions

Sofosbuvirdaclatasvir

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Marwa Salama, Consultant

    Tanta University - Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief Abd-Elsalam, ass. prof.

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

sherief abd-elsalan, ass. prof.

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

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

July 4, 2020

First Posted

July 7, 2020

Study Start

August 1, 2020

Primary Completion

August 1, 2021

Study Completion

August 31, 2021

Last Updated

December 8, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)