Covid19
Conditions
Brief summary
The study is open label randomized interventional phase 3 clinical trial. Patients with confirmed Covid-19 cases who was hospitalized in Two university isolation hospitals (Ain Shams University and Assiut University ) assigned hospitals for isolation.
Detailed description
The study is open label randomized interventional phase 3 clinical trial. Patients with confirmed Covid-19 cases who was hospitalized in Two university isolation hospitals (Ain Shams University and Assiut University ) assigned hospitals for isolation. The included patients receive. Intervention group: Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days + Methylprednisolone 1-2mg/kg for 5-7 days Control group: standard of care without Remdesivir
Interventions
DRUGRemdesivir
Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days
DRUGStandard of care_1
Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days
DRUGStandard of care_2
Methylprednisolone 1-2mg/kg for 5-7 days
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Adult 18 -80 years old Must have laboratory confirmed COVID-19(A patient with laboratory confirmation (Positive RT-PCR) of COVID-19 infection, irrespective of clinical signs and symptoms according to Ain Shams University Hospitals Consensus Statement on Management of Adult COVID-19 Patients. Must have severe or immediately life-threatening COVID-19, * Severe disease is defined as: * Dyspnea, * Respiratory frequency ≥ 30/min, * Blood oxygen saturation ≤ 93%, * Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or lung infiltrates \> 50% within 24 to 48 hours * Life-threatening disease is defined as: * respiratory failure, * septic shock, and/or * multiple organ dysfunction or failure * Must provide informed consent by patient or his/her legal guardian or Professional Legal Representative
Exclusion criteria
* Mild to moderately affected COVID 19 confirmed patients. * pregnancy, lactation. * known hepatic failure. * Patient who is not likely to comply to study procedures. * Creatine clearance \<30 ml/min. * Elevated transaminases \> 5 fold ULN.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of viral clearance | 14 days | Achievement of two successive negative COVID-19 PCR analysis tests 72 hours apart |
Countries
Egypt
Outcome results
None listed