NCT04779047

Brief Summary

Comparison outcomes of a large cohort of moderate and severe COVID-19 patients received different Antiviral and Anti Inflammatory Drugs.

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
150

participants targeted

Target at P25-P50 for phase_4 covid19

Timeline
Completed

Started Oct 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

October 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2021

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

February 25, 2021

Last Update Submit

March 15, 2021

Conditions

Covid19Pneumonia

Keywords

covid19

Outcome Measures

Primary Outcomes (1)

  • Percentage of clinical cure in each arm

    Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group before and after starting drugs

    through an average of 5-7 days

Study Arms (2)

group 1

ACTIVE COMPARATOR

Remdesivir will be administrated intravenously (IV) at a dose of 200 mg at day 1 then 100 mg once daily for 5 days and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days plus tocilizumab 800 mg once

Drug: RemdesivirDrug: TocilizumabDrug: Lopinavir/ Ritonavir

group 2

ACTIVE COMPARATOR

Hydroxychloroquine will be administrated at a dose of 400 mg twice daily at day 1 then 200 mg twice daily for 5 days and Ivermectin 36 mg at day 1,3 and 6 plus tocilizumab 800 mg once.

Drug: HydroxychloroquineDrug: TocilizumabDrug: Ivermectin

Interventions

RemdesivirDRUG

Remdesivir will be administrated intravenously (IV) at a dose of 200 mg at day 1 then 100 mg once daily for 5 days.

group 1
HydroxychloroquineDRUG

Hydroxychloroquine will be administrated at a dose of 400 mg twice daily at day 1 then 200 mg twice daily for 5 days.

group 2
TocilizumabDRUG

Tocilizumab 800 mg once.

Also known as: Actemra
group 1group 2
Lopinavir/ RitonavirDRUG

Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days.

Also known as: kaletra
group 1
IvermectinDRUG

Ivermectin 36 mg at day 1,3 and 6.

Also known as: Iverazine
group 2

Eligibility Criteria

Age18 Years - 88 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 \> 3-fold the upper limit of the normal range.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-suef University

Banī Suwayf, Egypt

RECRUITING

Related Publications (1)

  • Sarhan RM, Harb HS, Abou Warda AE, Salem-Bekhit MM, Shakeel F, Alzahrani SA, Madney YM, Boshra MS. Efficacy of the early treatment with tocilizumab-hydroxychloroquine and tocilizumab-remdesivir in severe COVID-19 Patients. J Infect Public Health. 2022 Jan;15(1):116-122. doi: 10.1016/j.jiph.2021.10.024. Epub 2021 Nov 2.

    PMID: 34764044DERIVED

MeSH Terms

Conditions

COVID-19Pneumonia

Interventions

remdesivirHydroxychloroquinetocilizumabLopinavirlopinavir-ritonavir drug combinationIvermectin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Marian Boshra, PhD

    Beni-Suef University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed E Abou warda, BSc

CONTACT

00201007647696ahmed.essam@o6u.edu.eg

Rania M Sarhan, PhD

CONTACT

0001008789509

Study Design

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

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 3, 2021

Study Start

October 1, 2020

Primary Completion

March 10, 2021

Study Completion

April 5, 2021

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)