NCT04551781

Brief Summary

A randomized controlled trial to study the efficacy of low dose steroid for 14 days in the treatment of post-covid-19 lung infiltrates

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable covid19

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

Study Start

First participant enrolled

April 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

September 13, 2020

Last Update Submit

September 14, 2020

Conditions

Covid19

Keywords

Covid-19post covid-19 fibrosislow dos steroids

Outcome Measures

Primary Outcomes (1)

  • improved

    resolution of CT chest infiltrates as evaluated by radiologest on a score of no infiltrates, \<5%, 5-25%and \>25 % infiltrates

    14 days

Study Arms (2)

steroid

EXPERIMENTAL

20 mg prednisolone for 14 days

Drug: 20 Mg Prednisone for 14 days

control

PLACEBO COMPARATOR

controll

Drug: control

Interventions

20 Mg Prednisone for 14 daysDRUG

20 Mg Prednisone for 14 days

Also known as: steroid
steroid
controlDRUG

symptomatic ttt

Also known as: symptomatic ttt
control

Eligibility Criteria

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

You may qualify if:

  • COVID-19 diagnosis with a positive nasopharyngeal swab, they were discharged from quarantine hospitals after 2 Polymerase chain reaction (PCR) swab negative for COVID-19, and have persistent radiological changes in follow-up chest computed tomography (CT) chest

You may not qualify if:

  • patients with normal CT chest at discharge, patients on chemotherapy, patients \<18years old, patients with known interstitial lung disease, and patients with rheumatoid arthritis or systemic lupus erythematosus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

south-Vally University faculty of medicine

Qina, Qena Governorate, 868532, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

PrednisoneSteroids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • alaa DR Rashad, MD

    south-Vally Universty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
single blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: single-blinded randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of chest diseases and tuberculosis

Study Record Dates

First Submitted

September 13, 2020

First Posted

September 16, 2020

Study Start

April 1, 2020

Primary Completion

July 30, 2020

Study Completion

July 30, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations

EG(1)