Steroid and Anticoagulant Therapy in covid19

NCT ID: NCT05021588

Last Updated: 2021-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-12

Study Completion Date

2020-09-10

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.

Detailed Description

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Conditions

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Pneumonia, Viral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group A:dexamethasone

Group Type EXPERIMENTAL

steroid and anticoagulants according to different protocols.

Intervention Type PROCEDURE

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.

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

Group Type EXPERIMENTAL

steroid and anticoagulants according to different protocols.

Intervention Type PROCEDURE

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.

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

Group Type EXPERIMENTAL

steroid and anticoagulants according to different protocols.

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Marwa mahmoud Abd El Rady

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Marwarady

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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anticoagulant in covid19

Identifier Type: -

Identifier Source: org_study_id

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