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

Primary Purpose

Pneumonia, Viral

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
steroid and anticoagulants according to different protocols.
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Viral

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Marwarady

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A:dexamethasone

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

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

Arm Description

Outcomes

Primary Outcome Measures

Outcome of patients after corticosteroids and anti-coagulants for severe COVID-19 pneumonia

Secondary Outcome Measures

Full Information

First Posted
August 16, 2021
Last Updated
August 23, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05021588
Brief Title
Steroid and Anticoagulant Therapy in covid19
Acronym
SARS-CoV-2
Official Title
Challenges in Steroid and Anticoagulant Therapy in Severe COVID-19 Pneumonia: A Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 12, 2020 (Actual)
Primary Completion Date
August 2, 2020 (Actual)
Study Completion Date
September 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Viral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A:dexamethasone
Arm Type
Experimental
Arm Title
Group B: prednisolone or methyl prednisolone according to D-dimer levels.
Arm Type
Experimental
Arm Title
Group C: prednisolone or methylprednisolone and anticoagulants according to the flexible protocol.
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
steroid and anticoagulants according to different protocols.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Outcome of patients after corticosteroids and anti-coagulants for severe COVID-19 pneumonia
Time Frame
5 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Marwarady
City
Asyut
ZIP/Postal Code
11711
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Steroid and Anticoagulant Therapy in covid19

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