ABSTRACT
Background: Infection during pregnancy can result in adverse outcomes for both pregnant persons and offspring. Maternal vaccination is an effective mechanism to protect both mother and neonate into post-partum. However, our understanding of passive transfer of antibodies elicited by maternal SARS-CoV-2 mRNA vaccination during pregnancy remains incomplete. Objective: We aimed to evaluate the antibody responses engendered by maternal SARS-CoV-2 vaccination following initial and booster doses in maternal circulation and breastmilk to better understand passive immunization of the newborn. Study Design: We collected longitudinal blood samples from 121 pregnant women who received SARS-CoV-2 mRNA vaccines spanning from early gestation to delivery followed by collection of blood samples and breastmilk between delivery and 12 months post-partum. During the study, 70% of the participants also received a booster post-partum. Paired maternal plasma, breastmilk, umbilical cord plasma, and newborn plasma samples were tested via enzyme-linked immunosorbent assays (ELISA) to evaluate SARS-CoV-2 specific IgG antibody levels. Results: Vaccine-elicited maternal antibodies were detected in both cord blood and newborn blood, albeit at lower levels than maternal circulation, demonstrating transplacental passive immunization. Booster vaccination significantly increased spike specific IgG antibody titers in maternal plasma and breastmilk. Finally, SARS-CoV-2 specific IgG antibodies in newborn blood correlated negatively with days post initial maternal vaccine dose. Conclusion: Vaccine-induced maternal SARS-CoV-2 antibodies were passively transferred to the offspring in utero via the placenta and after birth via breastfeeding. Maternal booster vaccination, regardless of gestational age at maternal vaccination, significantly increased antibody levels in breastmilk and maternal plasma, indicating the importance of this additional dose to maximize passive protection against SARS-CoV-2 infection for neonates and infants until vaccination eligibility. Keywords: Antibody, Booster, Breastmilk, COVID-19 vaccine, Newborn, Passive transfer
Subject(s)
COVID-19 , Spinal Cord DiseasesABSTRACT
Rationale: Coronavirus disease 2019 (COVID-19) leads to hospitalization and death, especially in elderly and those with comorbidities. There are evidences showing that sitagliptin and spironolactone can potentially improve the clinical outcomes of COVID-19 cases. Objective: In this observational study on acutely symptomatic outpatient COVID-19 cases, we investigated the effects of spironolactone and sitagliptin on the outcomes of the disease. Methods: : This prospective cohort study was conducted at Shiraz University of Medical Sciences Clinics during the fifth wave of the COVID-19 pandemic between July 2021 and September 2021. We followed mild to moderate symptomatic COVID-19 patients, who were treated with either combination (spironolactone 100 mg daily and sitagliptin 100 mg daily) or standard (steroid, antiviral and/or supportive care) therapy up to 30 days. Our primary outcome was hospitalization rate. The secondary outcomes included ER visit, duration of disease, and complications, such as hypoglycemia, low blood pressure or altered mental status. Results: : Of the 206 patients referred to clinics, 103 received standard therapy and 103 treated with combination therapy. There were no significant differences in baseline characteristics, except for slightly higher clinical score in control group (6.92 ± 4.01 control, 4.87 ± 2.92 combination; P <0.0001 ). Treatment with combination therapy was associated with lower admission rate (5.8% combination, 22.3% control; P = 0.0011 ), ER visits (7.8% combination, 23.3% control; P = 0.0021 ) and average duration of symptoms (6.67 ± 2.30 days combination, 18.71 ± 6.49 days control; P =<0.0001 ). Conclusion: In this prospective cohort study of acutely ill outpatients with COVID-19, the combination of sitagliptin and spironolactone reduced duration of COVID infection and hospital visits better than standard therapeutic approaches. The effects of combination of sitagliptin and spironolactone in COVID-19 patients should be further verified in a double blind, randomized, placebo-controlled trial. Iranian Registry of Clinical Trials IRCT registration number: IRCT20201003048904N2, Registration date: December 10, 2020.
Subject(s)
COVID-19 , HypoglycemiaABSTRACT
Background: Coronavirus disease 2019 (COVID-19) leads to hospitalization and death, especially in elderly and those with comorbidities. There are evidences showing that sitagliptin and spironolactone can potentially improve the clinical outcomes of COVID-19 cases. In this observational study on acutely symptomatic outpatient COVID-19 cases, we investigated the effects of spironolactone and sitagliptin on the outcomes of the disease. Methods: This prospective cohort study was conducted at Shiraz University of Medical Sciences Clinics during the fifth wave of the COVID-19 pandemic between July 2021 and September 2021. We followed mild to moderate symptomatic COVID-19 patients, who were treated with either combination (spironolactone 100 mg daily and sitagliptin 100 mg daily) or standard (steroid, antiviral and/or supportive care) therapy up to 30 days. Our primary outcome was hospitalization rate. The secondary outcomes included ER visit, duration of disease, and complications, such as hypoglycemia, low blood pressure or altered mental status. Results: Of the 206 patients referred to clinics, 103 received standard therapy and 103 treated with combination therapy. There were no significant differences in baseline characteristics, except for slightly higher clinical score in control group (6.92 +/- 4.01 control, 4.87 +/- 2.92 combination; P <0.0001). Treatment with combination therapy was associated with lower admission rate (5.8% combination, 22.3% control; P = 0.0011), ER visits (7.8% combination, 23.3% control; P = 0.0021) and average duration of symptoms (6.67 +/- 2.30 days combination, 18.71 +/- 6.49 days control; P =<0.0001). Conclusion: In this prospective cohort study of acutely ill outpatients with COVID-19, the combination of sitagliptin and spironolactone reduced duration of COVID infection and hospital visits better than standard therapeutic approaches. The effects of combination of sitagliptin and spironolactone in COVID-19 patients should be further verified in a double blind, randomized, placebo-controlled trial.
Subject(s)
COVID-19 , Hypoglycemia , Death , InfectionsABSTRACT
Background: COVID-19 may cause respiratory distress syndrome, ICU admission and death. Treatment of COVID-19 to prevent hospitalization, respiratory distress syndrome and death remains a priority. Our investigation sought to determine whether combination of spironolactone and Sitagliptin could reduce hospitalization for outpatient and death for inpatient with SARS-CoV-2 infection.Methods: This single blind, 4-arms, prospective randomized clinical trial was conducted at Shiraz University of Medical Sciences and Bushehr University of Medical Sciences hospitals during the second wave of the COVID-19 pandemic between December 2020 and April 2021. We randomized hospitalized adult patients with COVID-19 pneumonia into four groups: control (standard therapy), combination (Sitagliptin, spironolactone and standard therapy), Sitagliptin (Sitagliptin and standard therapy) or spironolactone (spironolactone and standard therapy). The primary outcome was the clinical improvement of the patients in the hospital as measured on an eight-point numerical scale ranging from no limitation of activities (score 1) to death (score 8). The secondary outcomes included intubation, ICU admission, end organ damages, CT findings and paraclinical information. We also treated 60 outpatients with SARS-CoV-2 infection to assess hospitalization rate.Results: 263 admitted patients were randomly assigned to control group (87 patients), combination group (60 patients), Sitagliptin group (66 patients) and Spironolactone group (50 patients). There were no significant differences in baseline characteristics, except for higher age in control group. The intervention groups, especially combination therapy, had better clinical outcomes. However, the mortality rate was lower in spironolactone receivers. Our intervention reduced lung infiltration but not the area of involvement in lung. The combination (Sitagliptin, spironolactone) therapy for outpatients with SARS-CoV-2 infection could reduce hospitalization rate to less than 2 percent.Conclusion: Sitagliptin and spironolactone can potentially improve clinical outcomes of hospitalized COVID-19 patients. Furthermore, early prescription of this combination can reduce hospitalization rate.Clinical Trial Registration Details: IRCT registration number: IRCT20201003048904N2, Registration date: December 10, 2020. Funding Information: This project is supported by Shiraz University of Medical Sciences, Bushehr University Medical Sciences, Faghihi Hospital and Shohadaye_Khalije_Fars Hospital. Declaration of Interests: The author has declared that no conflict of interest exists.Ethics Approval Statement: The ethics committee of Shiraz University of Medical Sciences (IR.SUMS.MED.REC.1399.550) and Bushehr University of Medical Sciences (IR.BPUMS.REC.1399.140) approved the study. We followed the declaration of Helsinki and Iranian national guidelines for ethics in research to design the study. The research physicians had routinely collected a written formal informed consent at the time of admission.