Oral famotidine versus placebo in non-hospitalised patients with COVID-19: a randomised, double-blind, data-intense, phase 2 clinical trial.

OBJECTIVE: We assessed whether famotidine improved inflammation and symptomatic recovery in outpatients with mild to moderate COVID-19. DESIGN: Randomised, double-blind, placebo-controlled, fully remote, phase 2 clinical trial (NCT04724720) enrolling symptomatic unvaccinated adult outpatients with confirmed COVID-19 between January 2021 and April 2021 from two US centres. Patients self-administered 80 mg famotidine (n=28) or placebo (n=27) orally three times a day for 14 consecutive days. Endpoints were time to (primary) or rate of (secondary) symptom resolution, and resolution of inflammation (exploratory). RESULTS: Of 55 patients in the intention-to-treat group (median age 35 years (IQR: 20); 35 women (64%); 18 African American (33%); 14 Hispanic (26%)), 52 (95%) completed the trial, submitting 1358 electronic symptom surveys. Time to symptom resolution was not statistically improved (p=0.4). Rate of symptom resolution was improved for patients taking famotidine (p<0.0001). Estimated 50% reduction of overall baseline symptom scores were achieved at 8.2 days (95% CI: 7 to 9.8 days) for famotidine and 11.4 days (95% CI: 10.3 to 12.6 days) for placebo treated patients. Differences were independent of patient sex, race or ethnicity. Five self-limiting adverse events occurred (famotidine, n=2 (40%); placebo, n=3 (60%)). On day 7, fewer patients on famotidine had detectable interferon alpha plasma levels (p=0.04). Plasma immunoglobulin type G levels to SARS-CoV-2 nucleocapsid core protein were similar between both arms. CONCLUSIONS: Famotidine was safe and well tolerated in outpatients with mild to moderate COVID-19. Famotidine led to earlier resolution of symptoms and inflammation without reducing anti-SARS-CoV-2 immunity. Additional randomised trials are required.

Nosocomial COVID-19 infection in women undergoing elective cesarean delivery: a prospective cohort study.

BACKGROUND: The COVID-19 pandemic placed obstetricians in a difficult position of continuing to perform elective cesarean delivery without the knowledge of the risk of the spread of nosocomial infection of the COVID-19 virus. OBJECTIVE: This study aimed to determine the nosocomial infection rate in women undergoing elective cesarean delivery at 2 academic institutions. STUDY DESIGN: This nonrandomized prospective cohort trial evaluated patients undergoing elective cesarean delivery during the reopening phase of the COVID-19 pandemic in the state of New York at 2 large volume labor and delivery units. Eligible patients with a negative preoperative reverse transcriptase-polymerase chain reaction test and immunoglobulin G antibody test for COVID-19 were retested 6 to 9 days after discharge. The primary objective was the COVID-19 test conversion rate defined as a positive polymerase chain reaction test for SARS-CoV-2 after discharge with a negative preoperative test. This was used as a proxy for the nosocomial infection rate. RESULTS: A total of 136 patients were screened for participation. Of these patients, 2 tested positive for COVID-19 on preoperative testing, and 25 declined to participate. Overall, 111 patients consented to participate, and 96 patients underwent both preoperative and postoperative testing. No patient with a negative polymerase chain reaction test preoperatively, had a positive polymerase chain reaction test for the COVID-19 virus postoperatively. CONCLUSION: With strict and methodical perioperative and postpartum protocols, we can limit nosocomial COVID-19 infection in women undergoing elective cesarean delivery.

Did surgical delay due to COVD-19 affect the short- and longer-term mental health of patients?

At the height of the COVID-19 pandemic, the US Surgeon General ordered the cessation of all elective surgical procedures. We evaluated the mental health impact of COVID-19 related surgical delay on patients awaiting procedures for benign, pre-malignant and malignant conditions. We sought to understand the short term impact of surgical delay and to identify potential longer term mental health affects after completion of the delayed procedure. All patients over age 18 awaiting surgery for benign, pre-malignant or malignant conditions in the gynecologic oncology, surgical oncology and colorectal services at Northwell Health were eligible. Upon enrollment, participants completed a baseline survey consisting of the Generalized Anxiety Disorder Questionnaire (GAD-7), the Penn State Worry Questionnaire (PSWQ), and Brief-Illness Patient Questionnaire (B-IPQ). Six weeks after their surgery, participants were sent a second survey consisting of the Center for Epidemiologic Studies Depression (CES-D) scale in addition to the GAD-7, PSWQ, and B-IPQ. 56 patients underwent their procedure and completed the follow-up survey. Patients with suspected benign conditions had a longer delay in scheduling their surgery than patients with suspected/confirmed cancer or pre-malignant conditions (101.4d vs 66.3d, p<0.05). There was no correlation of length of delay with postoperative worry, anxiety, or depression scores. There was no decrease in level of worry, as delineated by the PSWQ, among gynecologic oncology patients when comparing pre-operative to post-operative data. However, surgical oncology and colorectal patients demonstrated decreased post-operative worry. There was no difference in anxiety by surgical specialty.While the surgical delay was ongoing 79% of patients considered it to be moderately to extremely concerning, with 46% indicating the highest possible level of concern. Post-operatively, 47% of the respondents indicated moderate to extreme concern about the surgical delay, while 37% were not concerned. Initially, the surgical delay was considered to have a moderate to severe impact upon daily life by 65% of patients;which decreased to 53% at the time of post-operative follow-up. Interestingly, these relative decreases in patient concern were not significant when comparing pre-operative to post-operative values as a whole, by diagnosis or by specialty. 20% of participants qualified as depressed based on their response to the CES-D. Of these patients, 70% had a post-operatively confirmed cancer or pre-cancer. The incidence of depression was not affected by the post-operative diagnosis. Many patients experienced distress surrounding surgical delay due to the COVID-19 pandemic. This extended to their postoperative period. Gynecologic oncology patients did not experience decreased post-operative worry, while surgical oncology and colorectal patients did. There was no significant difference in the incidence of post-operative depression by specialty or post-operative diagnosis. [ABSTRACT FROM AUTHOR] Copyright of Gynecologic Oncology is the property of Academic Press Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Evidence that Maackia amurensis seed lectin (MASL) exerts pleiotropic actions on oral squamous cells with potential to inhibit SARS-CoV-2 infection and COVID-19 disease progression.

COVID-19 was declared an international public health emergency in January, and a pandemic in March of 2020. There are over 125 million confirmed COVID-19 cases that have caused over 2.7 million deaths worldwide as of March 2021. COVID-19 is caused by the SARS-CoV-2 virus. SARS-CoV-2 presents a surface "spike" protein that binds to the ACE2 receptor to infect host cells. In addition to the respiratory tract, SARS-Cov-2 can also infect cells of the oral mucosa, which also express the ACE2 receptor. The spike and ACE2 proteins are highly glycosylated with sialic acid modifications that direct viral-host interactions and infection. Maackia amurensis seed lectin (MASL) has a strong affinity for sialic acid modified proteins and can be used as an antiviral agent. Here, we report that MASL targets the ACE2 receptor, decreases ACE2 expression and glycosylation, suppresses binding of the SARS-CoV-2 spike protein, and decreases expression of inflammatory mediators by oral epithelial cells that cause ARDS in COVID-19 patients. In addition, we report that MASL also inhibits SARS-CoV-2 infection of kidney epithelial cells in culture. This work identifies MASL as an agent with potential to inhibit SARS-CoV-2 infection and COVID-19 related inflammatory syndromes.

Evidence that Maackia amurensis seed lectin (MASL) exerts pleiotropic actions on oral squamous cells to inhibit SARS-CoV-2 infection and COVID-19 disease progression.

COVID-19 was declared an international public health emergency in January, and a pandemic in March of 2020. There are over 23 million confirmed COVID-19 cases that have cause over 800 thousand deaths worldwide as of August 19th, 2020. COVID-19 is caused by the SARS-CoV-2 virus. SARS-CoV-2 presents a surface "spike" protein that binds to the ACE2 receptor to infect host cells. In addition to the respiratory tract, SARS-Cov-2 can also infect cells of the oral mucosa, which also express the ACE2 receptor. The spike and ACE2 proteins are highly glycosylated with sialic acid modifications that direct viral-host interactions and infection. Maackia amurensis seed lectin (MASL) has a strong affinity for sialic acid modified proteins and can be used as an antiviral agent. Here, we report that MASL targets the ACE2 receptor, decreases ACE2 expression and glycosylation, suppresses binding of the SARS-CoV-2 spike protein, and decreases expression of inflammatory mediators by oral epithelial cells that cause ARDS in COVID-19 patients. This work identifies MASL as an agent with potential to inhibit SARS-CoV-2 infection and COVID-19 related inflammatory syndromes.