NCT04738045

Brief Summary

Comparison outcomes of a large cohort of moderate and severe COVID-19 patients received remdesivir alone with patients who received remdesivir in combination with lopinavir/ ritonavir in addition to standard management.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P25-P50 for phase_4 covid19

Timeline
Completed

Started Nov 2020

Shorter than P25 for phase_4 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2021

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

January 31, 2021

Last Update Submit

March 15, 2021

Conditions

Covid19

Keywords

RemdesivirLopinavir/ Ritonavir

Outcome Measures

Primary Outcomes (1)

  • Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group

    Clinical cure will be assessed after 5-7 days from starting treatment based on: 1. Improvement in oxygenation (SpO2/FiO2 ratio). 2. Time to improvement in oxygenation. 3. Duration of hospitalization. 4. Mortality rate.

    "through study completion, an average of 3 months"

Secondary Outcomes (1)

  • Monitoring of adverse events.

    "through study completion, an average of 3 months"

Study Arms (2)

control

PLACEBO COMPARATOR

Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily for 5 days.

Drug: Remdesivir

interventional

EXPERIMENTAL

Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days.

Drug: Lopinavir/ Ritonavir and Remdesivir combination

Interventions

RemdesivirDRUG

Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily.

Also known as: control
control
Lopinavir/ Ritonavir and Remdesivir combinationDRUG

Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days

Also known as: intervention
interventional

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized adult patients with pneumonia evidenced by chest CT scan.
  • Laboratory (RT-PCR) confirmed infection with 2019-nCoV or strongly suspected to be infected with SARS-COV2 with confirmation studies pending.
  • And at least one of the following:
  • Respiratory frequency ≥30/min.
  • Blood oxygen saturation ≤93% on room air (RA).
  • Partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) \<300.
  • Worsening of lung involvement, defined as an increase in number and/or extension of pulmonary areas of consolidation, need for increased FiO2 to maintain stable O2 saturation, or worsening O2 saturation of \>3% with stable FiO2.

You may not qualify if:

  • Baseline elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 5-fold the upper limit of the normal range.
  • Pregnancy.
  • Known hypersensitivity to drugs or any component of the formulation.
  • Serious co-morbidity, including: Hepatic patients child Pugh class C.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-suef University

Banī Suwayf, Egypt

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

remdesivirLopinavirRitonavirMethods

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzolesInvestigative Techniques

Study Officials

  • Rania M Sarhan, PhD

    Beni-Suef University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed E Abou warda, BSc

CONTACT

00201007647696ahmed.essam@o6u.edu.eg

Marian Boshra, PhD

CONTACT

00201280571448

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 31, 2021

First Posted

February 4, 2021

Study Start

November 1, 2020

Primary Completion

March 28, 2021

Study Completion

April 1, 2021

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

EG(1)