Remdesivir Efficacy In Management Of COVID-19 Patients

Phase 3

Completed

• Conditions: Covid19
• Interventions: Drug: Standard of care_1; Drug: Remdesivir; Drug: Standard of care_2

• Registration Number: NCT04853901
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study Start: 2020-07-27
• Primary Completion: 2021-01-01
• Study Completion: 2021-03-01
• Study First Submitted: 2021-03-01
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-17
• Last Update Submitted: 2021-04-17
• Study First Posted: 2021-04-22
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care therapy	Standard of care_1	Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days + Methylprednisolone 1-2mg/kg for 5-7 days
Standard of care therapy	Standard of care_2	Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days + Methylprednisolone 1-2mg/kg for 5-7 days
Remdesivir	Remdesivir	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

Primary Outcome Measures

Name	Time	Method
Evaluation of viral clearance	14 days	Achievement of two successive negative COVID-19 PCR analysis tests 72 hours apart

Trial Locations

Locations (1)

Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center; 🇪🇬 Cairo, Non-US, Egypt