New Antiviral Drugs for Treatment of COVID-19

Summary

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

Conditions

• COVID
• Drug Effect

Interventions

DRUG

Treatment group: will receive a combination of Nitazoxanide, Ribavirin and Ivermectin for a duration of seven days :

Target population: 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. * Sample size: will depends on sequential analysis until a significant effect will be detected with a maximum of 100 subjects in each arm. * Randomization: subjects will be allocated to either arm by block randomization method with sealed opaque envelops. Each block will include 10 subjects (to be allocated randomly as 5 in each group) * Intervention: A) Treatment group: will receive a combination of Nitazoxanide, Ribavirin and Ivermectin for a duration of seven days

Sponsors & Collaborators

• Mansoura University

  lead OTHER

Principal Investigators

• HATEM ELALFY, MD · PROFESSOR OF ENDEMIC MEDICINE DEPARTMENT

• HATEM ELALFY, MD · Mansoura University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-31

Primary Completion

2022-05-31

Completion

2022-05-31

Countries

• Egypt

Study Locations