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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Viral

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