Steroid and Anticoagulant Therapy in covid19
SARS-CoV-2
Challenges in Steroid and Anticoagulant Therapy in Severe COVID-19 Pneumonia: A Prospective Study
1 other identifier
interventional
123
1 country
1
Brief Summary
As COVID-19 has neither standard treatment protocol nor guidelines, there are many treatment protocols foranti-inflammatory corticosteroids and anti-coagulations for severe COVID-19 pneumonia patients. This study aimed to assess the most suitable modality in this high-risk group. Methods: A prospective, experimental study design was adopted, that included 123 severe COVID-19 pneumonia patientsadmitted at Assiut UniversityHospital from April 10th, 2020, to September10th, 2020. Patients were divided into 3 groups according to a combined corticosteroid and anticoagulants therapy protocols. Group A included 32 patients, group B included 45 patients, and group C included 46 patients. Assessment of cases was conducted according to the treatment type and duration, weaning duration from oxygen therapy, length of hospital and ICU stay, and complications during treatment.Three months follow up after discharge was performed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2020
CompletedFirst Submitted
Initial submission to the registry
August 16, 2021
CompletedFirst Posted
Study publicly available on registry
August 25, 2021
CompletedAugust 25, 2021
August 1, 2021
4 months
August 16, 2021
August 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Outcome of patients after corticosteroids and anti-coagulants for severe COVID-19 pneumonia
5 months
Study Arms (3)
Group A:dexamethasone
EXPERIMENTALGroup B: prednisolone or methyl prednisolone according to D-dimer levels.
EXPERIMENTALGroup C: prednisolone or methylprednisolone and anticoagulants according to the flexible protocol.
EXPERIMENTALInterventions
As no standard treatment for COVID-19 was approved; there are many treatment protocols for anti-inflammatory corticosteroids and anti-coagulantsfor severe COVID-19 pneumonia cases, this study aims to assess the most suitable modality in this high-risk group.
Eligibility Criteria
You may qualify if:
- respiratory distress \[respiratory rate (RR) \>30 breaths/min at rest\], mean oxygen saturation ≤93%,ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) ≤300 mmHg,\>50% lung involvement on imaging within 24 to 48 hours of admission
You may not qualify if:
- pnumonia not caused by covid19
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marwarady
Asyut, 11711, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
August 16, 2021
First Posted
August 25, 2021
Study Start
April 12, 2020
Primary Completion
August 2, 2020
Study Completion
September 10, 2020
Last Updated
August 25, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share