Steroid and Anticoagulant Therapy in covid19 (SARS-CoV-2)

Assiut University

Status: Completed

Conditions: Pneumonia, Viral

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05021588

anticoagulant in covid19

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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123 participants in 3 patient groups

Group A:dexamethasone

Experimental group

Treatment:

Procedure: steroid and anticoagulants according to different protocols.

Group B: prednisolone or methyl prednisolone according to D-dimer levels.

Experimental group

Treatment:

Procedure: steroid and anticoagulants according to different protocols.

Group C: prednisolone or methylprednisolone and anticoagulants according to the flexible protocol.

Experimental group

Treatment:

Procedure: steroid and anticoagulants according to different protocols.