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NCT05021588 Clinical Trial

Steroid and Anticoagulant Therapy in covid19

Pneumonia, Viral Clinical Trial

— SARS-CoV-2  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05021588
Other study ID # anticoagulant in covid19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 12, 2020
Est. completion date September 10, 2020

Study information
Verified date August 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 123
Est. completion date September 10, 2020
Est. primary completion date August 2, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• steroid and anticoagulants according to different protocols.
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.

Locations
Country Name City State
Egypt Marwarady Asyut

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Outcome of patients after corticosteroids and anti-coagulants for severe COVID-19 pneumonia 5 months
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