Remdesivir Efficacy In Management Of COVID-19 Patients

• ClinicalTrials.gov Identifier: NCT04853901
• Recruitment Status: Completed
• First Posted: April 22, 2021
• Last Update Posted: April 22, 2021
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Hany Dabbous, Ain Shams University

Tracking Information

• First Submitted Date: March 1, 2021
• First Posted Date: April 22, 2021
• Last Update Posted Date: April 22, 2021
• Actual Study Start Date: July 27, 2020
• Actual Primary Completion Date: January 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 17, 2021)

Evaluation of viral clearance [ Time Frame: 14 days ]

Achievement of two successive negative COVID-19 PCR analysis tests 72 hours apart

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Remdesivir Efficacy In Management Of COVID-19 Patients
• Official Title: Remdesivir Efficacy In Management Of COVID-19 Patients
• 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Covid19

Intervention

• Drug: Remdesivir
  Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days
  Other Name: Veklury
• Drug: Standard of care_1
  Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days
  Other Name: Plaquenil
• Drug: Standard of care_2
  Methylprednisolone 1-2mg/kg for 5-7 days
  Other Name: Steroid

Study Arms

• Experimental: 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
  Intervention: Drug: Remdesivir
• Active Comparator: Standard of care therapy
  Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days + Methylprednisolone 1-2mg/kg for 5-7 days
  Interventions:

  • Drug: Standard of care_1
  • Drug: Standard of care_2

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 17, 2021): 77
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 1, 2021
• Actual Primary Completion Date: January 1, 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT04853901
• Other Study ID Numbers: FMASU P56a/ 2020
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Hany Dabbous, Ain Shams University
• Original Responsible Party: Same as current
• Current Study Sponsor: Ain Shams University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Hany E Dabbous, M.D; Faculty of Medicine Ain Shams University

• PRS Account: Ain Shams University
• Verification Date: April 2021