A Phase 4 interventional study of standard treatment COVID-19 + Triazavirin in Covid19, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-07-22.
Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 80 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will take the standard treatment COVID-19 + Triazavirin 250mg three times daily for 7 days\]
Drug: standard treatment COVID-19 + Triazavirin
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
Also known as: standard treatment COVID-19 + Oseltamivir
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).
Time frame: baseline
Time to recovery
(temperature ≤37.0°С, no intoxication symptoms) depending on time of therapy initiation (infection day 1 or 2) in the two groups.
Time frame: 7 days
Incidence of re-detection of viral RNA using PCR
(% of patients with positive PCR)
Time frame: 7 days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
* 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
Time frame: 1 month
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Ain Shams University