Steroid and Anticoagulant Therapy in covid19

Study Overview
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Brief Summary
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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.

Official Title
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Challenges in Steroid and Anticoagulant Therapy in Severe COVID-19 Pneumonia: A Prospective Study

Conditions
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Pneumonia, Viral

Intervention / Treatment
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* Procedure: steroid and anticoagulants according to different protocols.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: pnumonia not caused by covid19
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A:dexamethasone<br> | Procedure: steroid and anticoagulants according to different protocols.<br>* 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.<br>|
| Experimental: Group B: prednisolone or methyl prednisolone according to D-dimer levels.<br> | Procedure: steroid and anticoagulants according to different protocols.<br>* 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.<br>|
| Experimental: Group C: prednisolone or methylprednisolone and anticoagulants according to the flexible protocol.<br> | Procedure: steroid and anticoagulants according to different protocols.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome of patients after corticosteroids and anti-coagulants for severe COVID-19 pneumonia |  | 5 months |