Remdesivir Efficacy In Management Of COVID-19 Patients

Ain Shams University

Status and phase: Completed; Phase 3

Conditions: Covid19

Treatments: Drug: Standard of care_1; Drug: Standard of care_2; Drug: Remdesivir

Study type: Interventional

Funder types: Other

Identifiers

NCT04853901

FMASU P56a/ 2020

Details and patient eligibility

About

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.

Full 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

Enrollment: 77 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

Remdesivir

Experimental group

Description:

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

Treatment:

Drug: Remdesivir

Standard of care therapy

Active Comparator group

Description:

Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days + Methylprednisolone 1-2mg/kg for 5-7 days

Treatment:

Drug: Standard of care_2

Drug: Standard of care_1