Timing of Corticosteroids in COVID-19, II. Post COVID-19 Follow-up
1 other identifier
interventional
752
1 country
1
Brief Summary
Timing of of corticosteroids administration is very important in COVID19 cases for the recovery and decrease the mortality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 covid19
Started Mar 2021
Longer than P75 for phase_4 covid19
1 active site
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
August 24, 2020
CompletedFirst Posted
Study publicly available on registry
August 28, 2020
CompletedStudy Start
First participant enrolled
March 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2023
CompletedSeptember 6, 2023
September 1, 2023
8 months
August 24, 2020
September 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of cases that will need hospitalization
Deterioration in the clinical picture of cases that necessitate hospitalization
10 days
Percentage of cases that will need oxygen supplementation
Percentage of cases whose clinical status deteriorate that their sPO2 become less than 92%
10 days
28-days mortality
Percentage of cases who died within 28 days of presentation
28 days
Secondary Outcomes (6)
Percentages of COVID-19 Severity according to CDC 2020
10 days
Time to return to daily activity
60 days
Percentage of cases with increased d-dimer
10 days
Percentage reduction in CRP
10 days
Percentage reduction in LDH
10 days
- +1 more secondary outcomes
Study Arms (2)
Early CS
EXPERIMENTALearly use of dexamethasone as early as the laboratory confirmation of inflammation.
Late CS
NO INTERVENTIONDexamethasone is to be used lately upon the deterioration of cases i.e. sPO2 \< 92%
Interventions
early use of dexamethasone/Methylprednisolone as early as laboratory evidence of high inflammatory markers
Eligibility Criteria
You may qualify if:
- any case with COVID-19 more than or equal to 18 years
- mild and moderate severity
You may not qualify if:
- Severe to critical COVID-19
- Any contra-indication for the interventional drug
- Mentally disabled cases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ClinAmygatelead
Study Sites (1)
Asalam
Maadi, Cairo Governorate, 11433, Egypt
Related Publications (1)
Spoorenberg SM, Deneer VH, Grutters JC, Pulles AE, Voorn GP, Rijkers GT, Bos WJ, van de Garde EM. Pharmacokinetics of oral vs. intravenous dexamethasone in patients hospitalized with community-acquired pneumonia. Br J Clin Pharmacol. 2014 Jul;78(1):78-83. doi: 10.1111/bcp.12295.
PMID: 24400953BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emad R Issak
Assalam Clinics
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
August 24, 2020
First Posted
August 28, 2020
Study Start
March 20, 2021
Primary Completion
November 1, 2021
Study Completion
October 15, 2023
Last Updated
September 6, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share