Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triazavirin group | Active Comparator | Patients will take the standard treatment COVID-19 + Triazavirin 250mg three times daily for 7 days] |
|
| Oseltamivir group | Active Comparator | Patients will take the standard treatment COVID-19 + Oseltamivir 75 mg twice daily for 7 days] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard treatment COVID-19 + Triazavirin | Drug | to evaluate the efficacy and safety (side effects and / or adverse effects) of Triazavirin and Oseltamivir as treatment of Coronavirus Disease 2019 |
| Measure | Description | Time Frame |
|---|---|---|
| Physicians Global Assessment to measure the baseline COVID-19 signs and symptoms |
| baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days |
| Incidence of re-detection of viral RNA using PCR |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amal A Elkholy, PhD | Contact | +201060355448 | amalanas9@gmail.com | |
| Sara S. El-Menshawy, Master | Contact | +01117433794 | sarasamir967@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nagwa A Sabri, professor | Department of Clinical Pharmacy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fever Hospital of the Egyptian Armed Forces | Recruiting | Cairo | 012345 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32105609 | Background | 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. | |
| 32065057 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C539416 | riamilovir |
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
Not provided
Not provided
Simple Randomization Parallel Double Blinded.
Not provided
Not provided
To ensure blindness one placebo capsule will be added to group B.
|
(% of patients with positive PCR)
| 7 days |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] |
| 1 month |
| 32582306 | Background | 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. |
| 32056407 | Background | 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. |
| 39539144 | Derived | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |