Remdesivir Efficacy In Management Of COVID-19 Patients

Remdesivir Efficacy In Management Of COVID-19 Patients

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 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

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.