Challenges in Steroid and Anticoagulant Therapy in Severe COVID-19 Pneumonia: A Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Assiut University
- Enrollment
- 123
- Locations
- 1
- Primary Endpoint
- Outcome of patients after corticosteroids and anti-coagulants for severe COVID-19 pneumonia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Sex
- 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
Arms & Interventions
Group A:dexamethasone
Intervention: steroid and anticoagulants according to different protocols. (Procedure)
Group B: prednisolone or methyl prednisolone according to D-dimer levels.
Intervention: steroid and anticoagulants according to different protocols. (Procedure)
Group C: prednisolone or methylprednisolone and anticoagulants according to the flexible protocol.
Intervention: steroid and anticoagulants according to different protocols. (Procedure)
Outcomes
Primary Outcomes
Outcome of patients after corticosteroids and anti-coagulants for severe COVID-19 pneumonia
Time Frame: 5 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Marwa mahmoud Abd El Rady
lecturer
Assiut University