Back to results

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.

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

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

NCT ID

NCT05021588

First Posted

August 16, 2021

Last Updated

August 23, 2021

Sponsor

Assiut University

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

Studies a U.S. FDA-regulated Device Product

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

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

Learn more about this trial

Steroid and Anticoagulant Therapy in covid19

We'll reach out to this number within 24 hrs