Remdesivir Efficacy In Management Of COVID-19 Patients

• Status: Completed
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Hydroxychloroquine; Remdesivir

Criteria

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.