COVID Clinical Trial
Official title:
Effect of a Combination of Nitazoxanide, Ribavirin and Ivermectin Plus Zinc Supplement on the Clearance of COVID-19: a Pilot Sequential Clinical Trial
Background: In December 2019, SARS-CoV-2 was isolated on Vero E6 and Huh7 cell lines after an
outbreak of pneumonia of unknown origin in Wuhan, Hubei Province, China. Since the basis for
pathogenesis of this virus and its proliferation is unclear, there is still no definitive
treatment or vaccine against it. Thus, medications used against SARS-CoV-2 are mainly based
on their effectiveness on in vitro studies, virtual screenings and records of their effects
on earlier strains of coronavirus, SARS and MERS. Therefore, the immediate introduction of
potential COVID-19 treatments can be essential and salvaging. Aim: to compare the rate and
time of viral clearance in subjects receiving the combination of Nitazoxanide, Ribavirin and
Ivermectin vs. those control group (without any intervention). Methods: a sequential clinical
trial in this design sample size is not fixed in advance. Instead data will be evaluated as
they are collected, and further sampling is will be stopped in accordance with a pre-defined
stopping rule as soon as significant results are observed. After "n" (10 subjects in each
group) subjects in each group are available an interim analysis will be conducted. A
statistical test will be performed to compare the two groups and if the null hypothesis is
rejected the trial is terminated; otherwise, the trial continues, another n subjects per
group will be recruited, and the statistical test is performed again, including all subjects.
If the null is rejected, the trial is terminated, and otherwise it continues with periodic
evaluations until a maximum number of interim analyses have been performed, at which point
the last statistical test is conducted and the trial is discontinued [25]. Outcome: The
combination of Nitazoxanide, Ribavirin, Ivermectin and Zinc could be effective in clearance
of COVID 19.
KEY WOARD: COVID-19; clinical trial; corona virus
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | May 2022 |
Est. primary completion date | May 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility |
Inclusion Criteria: - any subject with COVID-19 PCR positive pharyngeal swab and referred to the above-mentioned quarantine without any comorbidities and no sensitivity or contraindication to the three drugs. Exclusion Criteria: - PATIENTS WITH COMORBIDITY :ISCHEMIC HEART DISEASES,OR KNOWN HYPERSENSITIVITY TO THE DRUGS |
Country | Name | City | State |
---|---|---|---|
Egypt | Mansoura University | Mansoura | Select A State Or Province |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3. — View Citation
Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol. 2019 Mar;17(3):181-192. doi: 10.1038/s41579-018-0118-9. Review. — View Citation
Graci JD, Cameron CE. Mechanisms of action of ribavirin against distinct viruses. Rev Med Virol. 2006 Jan-Feb;16(1):37-48. Review. — View Citation
Rossignol JF. Nitazoxanide: a first-in-class broad-spectrum antiviral agent. Antiviral Res. 2014 Oct;110:94-103. doi: 10.1016/j.antiviral.2014.07.014. Epub 2014 Aug 7. Review. — View Citation
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | negative test result for COVID-19 | PCR FOR COVID-19 will be done on serial visits till turn to negative, first after 5 day then serial every 48 hours till become negative for two consecutive samples. | 2 YEARS |
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