Remdesivir Efficacy In Management Of COVID-19 Patients

NCT04853901 | Completed Phase 3 DMC

• 1 other identifier: FMASU P56a/ 2020
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Evaluation of viral clearance

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

  14 days

Study Arms (2)

Remdesivir

EXPERIMENTAL

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

Drug: Remdesivir

Standard of care therapy

ACTIVE COMPARATOR

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

Drug: Standard of care_1; Drug: Standard of care_2

Interventions

Remdesivir DRUG

Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days

Also known as: Veklury

Remdesivir

Standard of care_1 DRUG

Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days

Also known as: Plaquenil

Standard of care therapy

Standard of care_2 DRUG

Methylprednisolone 1-2mg/kg for 5-7 days

Also known as: Steroid

Standard of care therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center

Cairo, Non-US, 11566, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

remdesivir; Hydroxychloroquine; Steroids

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Hany E Dabbous, M.D

  Faculty of Medicine Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Tropical Medicine Faculty of Medicine Ain Shams University

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: April 22, 2021
• Study Start: July 27, 2020
• Primary Completion: January 1, 2021
• Study Completion: March 1, 2021
• Last Updated: April 22, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)