Sofosbuvir and daclatasvir compared with standard of care in the treatment of patients admitted to hospital with moderate or severe coronavirus infection (COVID-19): a randomized controlled trial.

BACKGROUND: Currently no effective antiviral therapy has been found to treat COVID-19. The aim of this trial was to assess if the addition of sofosbuvir and daclatasvir improved clinical outcomes in patients with moderate or severe COVID-19. METHODS: This was an open-label, multicentre, randomized controlled clinical trial in adults with moderate or severe COVID-19 admitted to four university hospitals in Iran. Patients were randomized into a treatment arm receiving sofosbuvir and daclatasvir plus standard care, or a control arm receiving standard care alone. The primary endpoint was clinical recovery within 14 days of treatment. The study is registered with IRCT.ir under registration number IRCT20200128046294N2. RESULTS: Between 26 March and 26 April 2020, 66 patients were recruited and allocated to either the treatment arm (n = 33) or the control arm (n = 33). Clinical recovery within 14 days was achieved by 29/33 (88%) in the treatment arm and 22/33 (67%) in the control arm (P = 0.076). The treatment arm had a significantly shorter median duration of hospitalization [6 days (IQR 4-8)] than the control group [8 days (IQR 5-13)]; P = 0.029. Cumulative incidence of hospital discharge was significantly higher in the treatment arm versus the control (Gray's P = 0.041). Three patients died in the treatment arm and five in the control arm. No serious adverse events were reported. CONCLUSIONS: The addition of sofosbuvir and daclatasvir to standard care significantly reduced the duration of hospital stay compared with standard care alone. Although fewer deaths were observed in the treatment arm, this was not statistically significant. Conducting larger scale trials seems prudent.

The Importance of Evaluating Serum Levels of Tumor Markers M2-PK and Inhibin A in Patients Undergoing Colonoscopy.

Despite the use of colonoscopy to detect colon cancer due to its aggressiveness, high cost, and lack of patient compliance, the use of laboratory tests with high accuracy and sensitivity, such as tumor marker M2-PK and Inhibin A is recommended and can be effective for early diagnosis and screening of patients in the early stages. We studied 46 patients admitted it the gastrointestinal ward of Amir al Momenin Hospital and 45 normal (age and sex-matched) subjects as a control group (case-control and retrospective studies). Before the colonoscopy, the level of tumor marker M2-PK in the stool sample and the serum level of Inhibin A were evaluated in patients and the control group. The level of tumor marker M2-PK was significantly higher in the group with hyperplastic polyps and colon cancer (P < .001) than in the control group. At the same time, there was no significant difference in Inhibin A level (P = .054). In the hyperplastic polyps group 73% and in the colorectal cancer group 27% had a positive immunochemical fecal occult blood (IFOBT) result, significantly higher than the control group (P < .001). Evaluation of the level of tumor marker M2-PK in the stool sample in association with the three-time iFOBT test method may be suggested as a quick and noninvasive method for screening and diagnosis of polyps and early stages of colon cancer.