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