Comparative Therapeutic Efficacy and Safety of Different Antiviral and Anti Inflammatory Drugs in COVID-19 Patients.

Comparative Therapeutic Efficacy and Safety of Remdesivir Plus Lopinavir/ Ritonavir and Tocilizumab Versus Hydroxychloroquine Plus Ivermectin and Tocilizumab in COVID-19 Patients.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04779047

Enrollment

150

Registered

2021-03-03

Start date

2020-10-01

Completion date

2021-04-05

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Pneumonia

Keywords

covid19

Brief summary

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

Detailed description

Aim of the study 1. To assess the difference in patients' clinical status improvement between patients. 2. To detect time to improvement in oxygenation among both groups. 3. To detect duration of hospitalization and mortality rate in both groups. 4. To detect incidence and duration of mechanical ventilation in both treatment arms. 5. To monitor of adverse events of both drugs

Interventions

DRUGRemdesivir

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

DRUGHydroxychloroquine

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

DRUGTocilizumab

Tocilizumab 800 mg once.

DRUGLopinavir/ Ritonavir

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

DRUGIvermectin

Ivermectin 36 mg at day 1,3 and 6.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 88 Years

Healthy volunteers

Inclusion criteria

* 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: 1. Respiratory frequency ≥30/min. 2. Blood oxygen saturation ≤93% on room air (RA). 3. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) \<300. 4. 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.

Exclusion criteria

* Baseline elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 3-fold the upper limit of the normal range. * Pregnancy.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of clinical cure in each arm	through an average of 5-7 days	Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group before and after starting drugs

Countries

Egypt

Contacts

Primary ContactAhmed E Abou warda, BSc

ahmed.essam@o6u.edu.eg00201007647696

Backup ContactRania M Sarhan, PhD

0001008789509

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026