Remdesivir Efficacy In Management Of COVID-19 Patients

Covid19 Clinical Trial

Official title:

Remdesivir Efficacy In Management Of COVID-19 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04853901
• Other study ID #: FMASU P56a/ 2020
• Status: Completed
• Phase: Phase 3
• Start date: July 27, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: April 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center	Cairo	Non-US

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of viral clearance	Achievement of two successive negative COVID-19 PCR analysis tests 72 hours apart	14 days