SARS-CoV-2: Steroid and Anticoagulant Therapy in covid19

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05021588
• Collaborator: (none)
• Enrollment: 123
• Location: 1
• Arms: 3
• Actual Duration (Months): 5
• Patients Per Site Per Month: 24.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia, Viral	Procedure: steroid and anticoagulants according to different protocols.	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 123 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Challenges in Steroid and Anticoagulant Therapy in Severe COVID-19 Pneumonia: A Prospective Study
• Actual Study Start Date: Apr 12, 2020
• Actual Primary Completion Date: Aug 2, 2020
• Actual Study Completion Date: Sep 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A:dexamethasone	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.
Experimental: Group B: prednisolone or methyl prednisolone according to D-dimer levels.	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.
Experimental: Group C: prednisolone or methylprednisolone and anticoagulants according to the flexible protocol.	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.

Outcome Measures

Primary Outcome Measures

1. Outcome of patients after corticosteroids and anti-coagulants for severe COVID-19 pneumonia [5 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marwarady	Asyut		Egypt	11711

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marwa mahmoud Abd El Rady, lecturer, Assiut University
• ClinicalTrials.gov Identifier: NCT05021588
• Other Study ID Numbers: anticoagulant in covid19
• First Posted: Aug 25, 2021
• Last Update Posted: Aug 25, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pneumonia; Pneumonia, Viral; Anticoagulants

Study Results

No Results Posted as of Aug 25, 2021