This is the first Egyptian research to be published in an international medical journal examining the use of the drug on coronavirus patients.
The clinical study was conducted at Almaza Hospital in cooperation with the central laboratories in Kobry El-Kobba.
The study was conducted by Dr. Mohamed El-Gohary, director of the Armed Forces Fever Hospital; Dr. Iman Medhat, professor of endemic diseases at Cairo University; and Dr. Amani Ibrahim, professors of endemic diseases at Ain Shams University.
The research included 250 patients who were confirmed to have the coronavirus after a PCR analysis and categorising their degree of infection as “medium” according to clinical symptoms, laboratory analyses, and CT scans of the lungs.
The study began in the initial wave of the pandemic from March 2020 until August 2020 on 250 patients, with the patients being divided into two equal groups.
The first group included patients who were treated with Sovaldi, and the second group included patients with the same pathological characteristics, who were treated with drugs using traditional protocols that included Tamiflu, Hydroxychloroquine, and Xeromycin.
The comparison between the two groups was in terms of clinical improvement of symptoms, length of stay of the patient in the hospital, number of patients who required admission to intensive care, as well as a comparison of laboratory results and periodic CT scans.
A significant increase was found in the shortening of the treatment period until recovery among patients in the first group by 71%, compared to 51% in the second group, as well as no complications from Sovaldi compared to patients in the second group.
Also, no deaths occurred among patients of the first group, while six deaths were recorded in the second group, noting that seven cases among patients of the first group required admission to intensive care, compared to six cases from the second group that received traditional treatment.
There were no statistically significant differences between the two groups in terms of laboratory results or improvement in CT scans.
The trial was registered at the government with registration number NCT04530422.
The study was conducted following all the CONSORT checklist 2010 steps.
In the S.L. group, 89 (71.2%) patients were cured, while only 51 (40.8%) patients were cured in the OCH group. The cure rate was significantly higher in the S.L. group (RR=1.75, p<0.001).
Kaplan-Meir plot showed a considerably higher cure over time in the S.L. group (Log-rank test, p=0.032).
There were no deaths in the S.L. group, but there were six deaths (4.8%) in the OCH group (RR=0.08, p=0.013). Seven patients (5.6%) in the S.L. group and six patients (4.8%) in the OCH group were admitted to the intensive care unit (ICU) (RR=1.17, P=0.776).
There were no significant differences between treatment groups regarding total leukocyte and neutrophils count, lymph, and urea.
From this study, the researchers concluded the efficacy of Sovaldi in treating moderate cases of COVID-19.
The advantages of the drug also included the ease of its use, the scarcity of side effects, and its cheap price in Egypt.
The researchers stressed that this promising survey study (pilot study) is considered the beginning of a more comprehensive research.
Further research will be conducted using a larger sample of patient across different hospitals and a different treatment protocol for the second group to confirm the effectiveness of the drug for treating coronavirus cases.
Short link: