Evaluation of The Efficacy of Triazavirin Versus Oseltamivir in Egyptian Patients Infected With COVID-19 (COVID-19)

July 21, 2021 updated by: Amal A. Elkholy, Ain Shams University

Evaluation of The Efficacy of Triazavirin Versus Oseltamivir in Egyptian Patients Infected With Coronavirus Disease 2019 (COVID-19)

The aim of this study is to evaluate the efficacy and safety (side effects and / or adverse effects) of Triazavirin and Oseltamivir as treatment of Coronavirus Disease 2019 in Egyptian patients in military hospitals.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In December 2019, a series of pneumonia cases of unknown cause emerged, followed by a rapidly spread due to strong human-to-human transmission in china. Based on the clinical presentation, the pneumonia was determined to be a viral infection; the virus was initially named the 2019 novel coronavirus (2019-nCoV) and then, formally, severe acute respiratory syndrome coronavirus2 (SARS-CoV-2). Most districts have reported zero increase of coronavirus disease 2019 (COVID-19) cases since March 2020. As of 11 March 2020, a total of 80 955 laboratory-confirmed cases had been documented in China.

The World Health Organization (WHO) declared COVID-19 to be a public health emergency of international concern on 30 January 2020. The mortality rate was found to be 3.9% according to the data at that time. Given the human-to-human transmission and high infectivity of the disease, COVID-19 has been rapidly spreading in Republic of Korea, Iran, Italy, the United States, and Europe. A number of studies and reports have identified a median incubation period of 4 d and have determined that the top four symptoms include fever, cough, shortness of breath, and chest tightness/pain.

The most unfortunate fact is that there have been no effective therapies for preventing and treating COVID-19 to date. Although Remdesivir and Hydroxychloroquine have been found to be effective in inhibiting SARS-CoV-2, the data obtained thus far are primarily from in vitro studies, but their effectiveness in vivo still questionable. Interferon, Lopinavir/ritonavir, Arbidol, Ribavirin, and the therapeutic application of plasma antibodies have also been recommended as alternatives for the treatment of patients with COVID-19; however, the efficacy and safety of these drugs remain to be verified in patients, and their applications are yet to be validated by scientifically sound randomized clinical trials (RCTs).

Triazavirin (TZV), a new antiviral drug, has been on the market in Russia since 2015. It is a synthetic compound analogue to the purine nucleoside bases. The principle mode of action of TZV is inhibiting the synthesis of viral RNA and preventing the replication of genomic fragments. Because of its multiple-target mechanism of action, TZV has a wide spectrum of antiviral activity against RNA-containing viruses, including influenza A virus (H5N1, etc.), influenza B virus, tick-borne encephalitis, and Forest-Spring encephalitis, both in vitro and in animal models in vivo.

Oseltamivir is a first-line antiviral drug, especially in primary hospitals of military medical hospitals. During the ongoing outbreak of coronavirus disease 2019 (COVID-19), most patients with COVID-19 who are symptomatic have used Oseltamivir. Considering its popular and important role as an antiviral drug, it is necessary to evaluate oseltamivir in the treatment of COVID-19 . Oseltamivir inhibits the neuraminidase enzyme, which is expressed on the viral surface. The enzyme promotes release of virus from infected cells and facilitates viral movement within the respiratory tract. In the presence of neuraminidase inhibitors, virions stay attached to the membrane of infected cells and are also entrapped in respiratory secretions.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 012345
        • Recruiting
        • Fever Hospital of the Egyptian Armed Forces
        • Contact:
          • Tarek R Elnagdy, PhD
          • Phone Number: 01117433794

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adults from 18 to 60 years old who signed informed consent;
  2. Laboratory confirmed SARS-CoV-2 infection by real-time RT-PCR.
  3. Chest computed tomography (CT) imaging-confirmed lung damage, including multiple small plaques and stromal changes in the lungs, which are obvious in the outer lung, or multiple ground-glass shadows and infiltration shadows in both lungs, although these changes might not be present in mild patients.
  4. Patients with history of fever (axillary temperature more than 37°С) or respiratory symptoms.

Exclusion Criteria:

  1. Patients who are unsuitable or who cannot participate safely in the study, as judged by the principal investigator (PI).
  2. Patients with serious liver disease (increase of liver transaminases enzymes).
  3. Patients with severe renal impairment (denoted by increase serum urea & serum creatinine) or continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
  4. Patients with severe anemia.
  5. Women with a positive pregnancy test, ongoing pregnancy, or who are breastfeeding.
  6. Patients with a history of allergy to medications or its metabolic components.
  7. Patients who have not signed informed consent.
  8. Patients participating in other clinical trials for COVID-19 within 30 days prior to screening.
  9. Patients participating in other clinical research in the past three months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Triazavirin group
Patients will take the standard treatment COVID-19 + Triazavirin 250mg three times daily for 7 days]
Drug: standard treatment COVID-19 + Triazavirin
to evaluate the efficacy and safety (side effects and / or adverse effects) of Triazavirin and Oseltamivir as treatment of Coronavirus Disease 2019
Other Names:
  • standard treatment COVID-19 + Oseltamivir
Active Comparator: Oseltamivir group
Patients will take the standard treatment COVID-19 + Oseltamivir 75 mg twice daily for 7 days]
Drug: standard treatment COVID-19 + Triazavirin
to evaluate the efficacy and safety (side effects and / or adverse effects) of Triazavirin and Oseltamivir as treatment of Coronavirus Disease 2019
Other Names:
  • standard treatment COVID-19 + Oseltamivir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physicians Global Assessment to measure the baseline COVID-19 signs and symptoms
Time Frame: baseline
  1. Temperature response (axillary temperature more than 37°С)
  2. Fever response (axillary temperature more than 37.8°С)
  3. General intoxication symptoms (e.g. headache, myalgia, eyebulb pain)
  4. Catarrhal symptoms (e.g.sore throat, cough).
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recovery
Time Frame: 7 days
(temperature ≤37.0°С, no intoxication symptoms) depending on time of therapy initiation (infection day 1 or 2) in the two groups.
7 days
Incidence of re-detection of viral RNA using PCR
Time Frame: 7 days
(% of patients with positive PCR)
7 days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 1 month
  • Computed Tomography (CT) chest
  • PCR (Polymerase chain reaction)
  • CBC (complete blood count)
  • Serum Ferritin in ug/L
  • Liver & kidney functions
  • Cardiac troponin in ng/L
  • Coagulation profile (INR-PT-PTT in minutes)
  • Blood glucose level in mg/dL
  • Erythrocyte Sedimentation Rate (ESR) in mm/hr
  • C-Reactive Protein (CRP) mg/dL
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Nagwa A Sabri, professor, Department of Clinical Pharmacy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

July 3, 2021

First Submitted That Met QC Criteria

July 21, 2021

First Posted (Actual)

July 22, 2021

Study Record Updates

Last Update Posted (Actual)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Antiviral therapy in COVID-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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