NCT04973462

Brief Summary

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.

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
80

participants targeted

Target at P25-P50 for phase_4 covid19

Timeline
Completed

Started Aug 2021

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

First Submitted

Initial submission to the registry

July 3, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

July 3, 2021

Last Update Submit

July 21, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Physicians Global Assessment to measure the baseline COVID-19 signs and symptoms

    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 Outcomes (3)

  • Time to recovery

    7 days

  • Incidence of re-detection of viral RNA using PCR

    7 days

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    1 month

Study Arms (2)

Triazavirin group

ACTIVE COMPARATOR

Patients will take the standard treatment COVID-19 + Triazavirin 250mg three times daily for 7 days\]

Drug: standard treatment COVID-19 + Triazavirin

Oseltamivir group

ACTIVE COMPARATOR

Patients will take the standard treatment COVID-19 + Oseltamivir 75 mg twice daily for 7 days\]

Drug: standard treatment COVID-19 + Triazavirin

Interventions

standard treatment COVID-19 + TriazavirinDRUG

to evaluate the efficacy and safety (side effects and / or adverse effects) of Triazavirin and Oseltamivir as treatment of Coronavirus Disease 2019

Also known as: standard treatment COVID-19 + Oseltamivir
Oseltamivir groupTriazavirin group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults from 18 to 60 years old who signed informed consent;
  • Laboratory confirmed SARS-CoV-2 infection by real-time RT-PCR.
  • 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.
  • Patients with history of fever (axillary temperature more than 37°С) or respiratory symptoms.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fever Hospital of the Egyptian Armed Forces

Cairo, 012345, Egypt

RECRUITING

Related Publications (5)

  • Chen S, Yang J, Yang W, Wang C, Barnighausen T. COVID-19 control in China during mass population movements at New Year. Lancet. 2020 Mar 7;395(10226):764-766. doi: 10.1016/S0140-6736(20)30421-9. Epub 2020 Feb 24. No abstract available.

    PMID: 32105609BACKGROUND

  • Zhang W, Du RH, Li B, Zheng XS, Yang XL, Hu B, Wang YY, Xiao GF, Yan B, Shi ZL, Zhou P. Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerg Microbes Infect. 2020 Feb 17;9(1):386-389. doi: 10.1080/22221751.2020.1729071. eCollection 2020.

    PMID: 32065057BACKGROUND

  • Sethi BA, Sethi A, Ali S, Aamir HS. Impact of Coronavirus disease (COVID-19) pandemic on health professionals. Pak J Med Sci. 2020 May;36(COVID19-S4):S6-S11. doi: 10.12669/pjms.36.COVID19-S4.2779.

    PMID: 32582306BACKGROUND

  • Lim J, Jeon S, Shin HY, Kim MJ, Seong YM, Lee WJ, Choe KW, Kang YM, Lee B, Park SJ. Case of the Index Patient Who Caused Tertiary Transmission of COVID-19 Infection in Korea: the Application of Lopinavir/Ritonavir for the Treatment of COVID-19 Infected Pneumonia Monitored by Quantitative RT-PCR. J Korean Med Sci. 2020 Feb 17;35(6):e79. doi: 10.3346/jkms.2020.35.e79.

    PMID: 32056407BACKGROUND

  • Mohamed Elmenshawy SS, Ahmed Abdelsalam MF, El Nagdy TR, Salam Elgohary MA, Sabri NA, El-Kholy A. Evaluation of the efficacy of triazavirin versus oseltamivir in management of COVID-19. Future Sci OA. 2024 Dec 31;10(1):2418798. doi: 10.1080/20565623.2024.2418798. Epub 2024 Nov 14.

    PMID: 39539144DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

riamilovirOseltamivir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Study Officials

  • Nagwa A Sabri, professor

    Department of Clinical Pharmacy

    STUDY CHAIR

Central Study Contacts

Amal A Elkholy, PhD

CONTACT

+201060355448amalanas9@gmail.com

Sara S. El-Menshawy, Master

CONTACT

+01117433794sarasamir967@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
To ensure blindness one placebo capsule will be added to group B.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Simple Randomization Parallel Double Blinded.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Dr.

Study Record Dates

First Submitted

July 3, 2021

First Posted

July 22, 2021

Study Start

August 1, 2021

Primary Completion

September 30, 2021

Study Completion

December 30, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Locations

EG(1)