Virucidal Effect of Povidone Iodine on SARS-CoV-2 in Nasopharynx: An Open-label Randomized Clinical Trial.

To assess the virucidal effect of povidone iodine (PVP-I) on severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) located in the nasopharynx and suitable dose-formulation for nasal application were the purpose of this clinical trial. This single-center, open-label randomized clinical trial with a 7-arm parallel-group design was conducted in Dhaka Medical College (DMC) Hospital. A total of 189 reverse transcription-polymerase chain reaction (RT-PCR)-confirmed SARS CoV-2 positive cases aged 12-90 years with symptoms was sequentially enrolled following randomization. Nasopharyngeal clearance of SARS-CoV-2 was tested against PVP-I nasal irrigation (NI) at diluted concentrations of 0.4%, 0.5% and 0.6%, and PVP-I nasal spray (NS) at diluted concentrations of 0.5% and 0.6%. All groups were compared to the corresponding controls (distilled water). Written informed consent was ensured before participation. All procedures were conducted in after ethical clearance from the Ethical Review Board and in accordance with the Declaration of Helsinki. Viral clearance in a repeat RT-PCR (qualitative) was the primary outcome, and occurrence of any adverse event following administration of testing drug was considered as the secondary outcome. Analysis was performed using SPSS (Version 26). All cases were randomized into seven groups and each group consists of 27-patient. Mean age of the cases 43.98 ± 12.67 years (SD). All strength of NI were effective in nasopharyngeal clearance compared to the control (0.4%, p = 0.006; 0.5%, p < 0.001; and 0.6%, p = 0.018). Similarly, all strength of the NS is also effective than control (0.5%, p = < 0.001; and 0.6%, p ≤ 0.001). Highest nasopharyngeal clearance was observed in patients using 0.5% NI (n = 25, 92.6%, p = 0.018). Nasal irritation was the single most adverse event recorded in this trial and found in two patients using 0.4%, and 0.6% PVP-I NI, respectively. Both PVP-I NS and NI are effective for nasopharyngeal clearance in-vivo. However, further community trials are needed to repurpose these solutions as preventive agents against SARS-CoV2. Ethical clearance memo no ERC-DMC/ECC/2020/93. Trial registration NCT Identifier number NCT04549376. Supplementary Information: The online version contains supplementary material available at 10.1007/s12070-022-03106-0.

Post-discharge quality of life of COVID-19 patients at 1-month follow-up: A cross-sectional study in the largest tertiary care hospital of Bangladesh.

There is increasing evidence of the post-COVID-19 suffering and decreased quality of life in the COVID-19 patients. This study aimed to assess the quality of life and associated factors of COVID-19 patients at one month after discharge from the hospital. This was a cross-sectional study that was conducted at the post-covid clinic of Dhaka Medical College Hospital (DMCH) where RT-PCR-confirmed adult COVID-19 recovered patients were enrolled one month after discharge from the same hospital. They were consecutively selected from January 01 to May 30. A pretested semi-structured questionnaire was used for the data collection for clinical variables. The generic multi-attributable utility instrument EQ-5D-5L was used for assessing health-related quality of life (HRQoL). A total of 563 patients were enrolled in the study. The patients had a mean age with standard deviation (±SD) of 51.18 (±13.49) years and 55.95% were male. The mean (SD) EQ-5D-5L index score and EQ-VAS scores were 0.78 (±0.19) and 70.26 (±11.13), respectively. Overall, 45.77%, 50.99%, 52.79%, 55.14% and 62.16% had problems (slight to extreme) in the mobility, self-care, usual activities, pain/discomfort and anxiety/depression dimensions, respectively. Patients aged ≥60 years had significant problem in mobility (odds ratio [OR] 3.24, 95% confidence interval [CI]: 1.07-9.77). Female participants were 5.50 times (95% CI: 2.22-13.62) more likely to have problems in their usual activities. In comparison to urban area, living in a peri-urban setting was significantly associated with problems in mobility (OR 1.89, 95% CI: 1.13-3.20), pain/discomfort (OR 1.82, 95% CI: 1.04-3.12) and anxiety/depression (OR 2.16, 95% CI: 1.22-3.84). Comorbid patients were 1.75 times (95% CI: 1.07-2.85) more likely to report problems in the pain/discomfort dimension. Presence of symptom(s) was associated with problems in self-care (OR 3.27, 95%CI: 1.31-8.18), usual-activity (OR 3.08, 95%CI: 1.21-7.87), pain/discomfort dimensions (OR 2.75, 95%CI: 1.09-6.96) and anxiety/depression (OR 3.35, 95%CI: 1.35-8.30). Specific management strategies should be planned to address the factors associated with low health-related quality of life in post-acute care of COVID-19 patients.

The impact of the COVID-19 pandemic on the mental health of Rohingya refugees with pre-existing health problems in Bangladesh.

BACKGROUND: Mental disorders among refugees have been well explored in several studies. However, longitudinal studies on the impact of the pandemic on refugee populations are widely lacking. This study was designed to examine the impact of the current pandemic on the mental health of Rohingya refugees living in Bangladesh. METHOD: This longitudinal study involved a convenience sample of 732 Rohingya people with pre-existing health problems who lived in the Kutupalong refugee camp in Cox's Bazar, Bangladesh. The first recruitment was performed on 5 July 2019 (prepandemic visit) and assessed the health status of refugees using the Refugee Health Screener-15 (RHS-15). The follow-up survey was conducted on 10 November 2020, approximately 15 months later, during the pandemic. A total of 342 Rohingya refugees who completed the initial survey participated in the follow-up survey. A newly developed COVID-19 Impact on Quality of Life (COV19-QoL) scale was used alongside the RHS-15 scale during the second survey. Ethical measures were taken in compliance with the current Declaration of Helsinki. The analysis was performed using SPSS 26. RESULT: A total of 342 Rohingya refugees completed this longitudinal survey. The average age of participants was 32.25 ± 14.01 years (SD), and the predominant age group was ≤ 30 years (n = 207, 60.5%). Most of the participants were female (n = 209, 61.1%). A significant increase in stress was noted from the prepandemic to pandemic periods, as determined by the RHS-15 scale (RHS-15 Part I: 22.96 ± 8.43 vs. 46.72 ± 1.87, p < 0.001; and RHS-15 Part II: 4.43 ± 1.59 vs. 6.91 ± 1.49, p < 0.001). The mean COV19-QoL score of the participants was 4.47 ± 0.15 (out of 5), indicating a perceived negative impact of the pandemic in their lives. In the multiple regression analysis, female sex (ß = 0.604, p = 0.017) and COV19-QoL score (ß = 2.537, p = 0.003) were significantly associated with higher perceived distress among participants. CONCLUSION: Rohingya refugees experienced a significant deterioration of mental health during the COVID-19 pandemic. Alongside other socioeconomic, environmental, and political factors, the pandemic itself might have been a crucial contributor to this negative trend.

Antibody Response to ChAdOx1-nCoV-19 Vaccine Among Recipients in Bangladesh: A Prospective Observational Study.

PURPOSE: The aim of the study was to assess the antibody response to the ChAdOx1-nCoV vaccine in individuals who were not previously infected by COVID-19. PATIENTS AND METHODS: All people aged 18-65 years who received their first vaccination with ChAdOx1-nCoV from March to May 2021 were approached for inclusion. Individuals with sufficient antibody titers against SARS-CoV-2 infection before vaccination were considered previously infected and were excluded from the analysis. We observed viral spike protein RBD-S1-specific IgG antibody levels at day 28 of the first dose of vaccination and day 14 of the second dose of vaccination (74 days from index vaccination). An optical density ratio (ODR) of >1.1 was considered to have a positive antibody response, 0.8 to 1.1 borderline and <0.8 was denoted as negative. Informed consent was ensured before enrollment, and ethical principles conformed with the current Declaration of Helsinki. RESULTS: This observational study comprised 769 infection-naïve individuals (mean age 40.5 years, 38.9% female). Spike-specific IgG antibody responses elicited after the first and second doses of vaccine were 99.9% and 100%, respectively. The median ODR was 5.43 (interquartile range [IQR]: 4.32-6.98) and 10.90 (IQR 9.02-11.90) after the first and second doses. Higher age was associated with lower antibody levels after both dosages. However, no sex-specific variation was seen. People with comorbidity had a lower antibody level after the second dose. Tenderness (51.46%) and fever (19.30%) were the most common local and systemic side effects after vaccination. CONCLUSION: This study was one of the earlier attempts in the country to assess the antibody response to ChAdOx1-nCoV vaccine recipients. The results imply that general people should be encouraged to take the vaccine at their earliest.

Mental health of young people amidst COVID-19 pandemic in Bangladesh.

BACKGROUND: The psychological burden of the coronavirus disease 2019 (COVID-19) outbreak and lockdown strategy among young people not diagnosed with COVID-19 in the general population remains unknown and often have been overlooked. The objective of the study was to assess the prevalence and predictors of anxiety, depression and stress among young people diagnosed with COVID-19 of Bangladesh amidst the pandemic. METHODS: A cross-sectional online survey was conducted from 1 May to 30 May 2020 using an online Google form-based questionnaire posted on Facebook. A snowball sampling approach was used for data collection. A total of 974 self-declared healthy individuals not diagnosed with COVID-19 participated here. Anxiety, depression and stress were measured using Bangla validated Generalized Anxiety Disorder Scale-7 (GAD-7), Patient Health Questionnaire (PHQ-9) scale, and Perceived Stress Scale (PSS), respectively. Statistical software SPSS 20 was used for analysis. RESULT: Average age of the population was 25.86 ± 6.26 (SD) years with nearly half (48.6%) of them being young people (15 to ≤24 years). Most of the participants were male (76.3%). The overall prevalence of anxiety, depression and stress was found to be 64.1%, 73.3% and 69.4%, respectively. Young people had significantly higher proportion of anxiety (67.2% vs 61.1%), and depression (78.2% vs 68.7%) compared to adults (p = 0.045 and p < 0.001, respectively). However, most of the participants had mild depression (30.3%), minimal anxiety (31.4%), and moderate stress (67.5%), and severity of depression and anxiety was higher in the young participants. The mean GAD-7, PHQ-9 and PSS scores were 7.57 ± 5.61, 9.19 ± 6.15 and 16.02 ± 5.55 (SD), respectively. On multivariable logistic analysis, unemployment (Adjusted Odds Ratio [AOR] 3.642; Confidence Interval [CI]: 1.005-13.200; p < 0.05) was the single most important predictor of depression. For stress, unemployment (AOR 1.399; CI: 1.055-1.855), and female sex (AOR 1.638; CI: 1.158-2.317) were significant predictors. CONCLUSION: Anxiety, depression and stress were highly prevalent among young people (≤24 years) not diagnosed with COVID-19 in Bangladesh amidst the pandemic. Unemployment is the most common underlying determinant. Authorities should address the issue on a priority basis.

Virucidal effect of povidone iodine on COVID-19 in the nasopharynx: an open-label randomized clinical trial.

Povidone-iodine (PVP-I) is a time-tested antiseptic agent with excellent virucidal (99.99%) properties. Repurposing it against coronavirus disease-19 (COVID-19) is a relatively newer concept and has been sparsely tested in vivo. The most common route of entry of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) is the nasopharynx. Averting colonization of the virus could be one of the best options to reduce the incidence of infection. PVP-I gargle and mouthwash were found to be effective in vitro rapid inactivation against SARS-CoV-2 on a smaller scale (Hassandarvish et al. in BDJ 1-4, 2020, Pelletier et al. in ENTJ 1-5, 2020). However, efficacy in humans is lacking. To assess the virucidal effect of PVP-I against SARS-CoV-2 located in the nasopharynx was the objective of this parallel armed randomized clinical trial. We screened all RT-PCR-confirmed COVID-19 cases aged 18 years and above with symptoms. Written informed consent was obtained before randomization. Nasopharyngeal clearance of SARS-CoV-2 was tested after single time application of PVP-I nasal irrigation (NI) at diluted concentrations of .4%, .5% and .6% and PVP-I nasal spray (NS) at diluted concentrations of .5% and .6%. All groups were compared to the corresponding controls (distilled water). The primary outcome was viral clearance in a repeat RT-PCR (qualitative), and the secondary outcome was the number of adverse events. Final data analysis was performed using the statistical software SPSS (Version 20). A total of 189 confirmed COVID-19 cases were randomized into seven groups: 27 patients in each group. Of all, 159 (84.1%) were male, and 30 (15.9%) were female. We observed a statistically significant proportion of nasopharyngeal clearance with all strengths of PVP-I NI and PVP-I NS compared to the corresponding controls. Additionally, 0.5% NI was significantly better than 0.5% NS for viral clearance (p = 0.018) and had the highest nasopharyngeal clearance among all strengths (n = 25, 92.6%). 0.6% NS is better than CNS and 0.5%NS in viral clearance. The only adverse event was nasal irritation recorded in two patients each in the 0.4% and 0.6% PVP-I NI groups (Tables 1 and 2). PVP-I NI and NS are proved as effective virucidal agent against SARS-CoV-2 in human body. Our recommendation is to use PVP-I in naopharynx (as well as oropharynx) to prevent COVID-19.

Virucidal effect of povidone iodine on COVID-19 in the nasopharynx: A structured summary of a study protocol for an open-label randomized clinical trial.

OBJECTIVE: General: To assess the virucidal efficacy of povidone iodine (PVP-I) on COVID-19 virus located in the nasopharynx Specific: i. To evaluate the efficacy of povidone iodine (PVP-I) to removeCOVID-19 virus located in the nasopharynx ii. To assess the adverse events of PVP-I TRIAL DESIGN: This is a single-center, open-label randomized clinical trial with a 7-arm parallel-group design. PARTICIPANTS: The study will be conducted at Dhaka Medical College Hospital, Dhaka, Bangladesh. INCLUSION CRITERIA: All RT-PCR-confirmed COVID-19 cases aged between 15-90 years with symptoms for the past 4 days will be screened. Those who give informed consent, are willing to participate, and accept being randomized to any assigned group will also be considered for final inclusion. EXCLUSION CRITERIA: Patients with known sensitivity to PVP-I aqueous antiseptic solution or any of its listed excipients or previously diagnosed thyroid disease or who had a history of chronic renal failure: stage ≥3 by estimated glomerular filtration rate (eGFR) Modification of Diet in Renal Disease (MDRD) or had acute renal failure (KDIGO ≥stage 2: creatinine ≥2 times from the baseline) or patients who required invasive or noninvasive ventilation or planned within the next 6 hours were considered for exclusion. Moreover, lactating or pregnant women will also be restricted to include here. INTERVENTION AND COMPARATOR: This RCT consist of seven arms: Arm-1 (intervention group): will receive povidone iodine (PVP-I) nasal irrigation (NI) at a concentration of 0.4% Arm-2 (intervention group): will receive PVP-I nasal irrigation at a concentration of 0.5% Arm-3 (intervention group): will receive PVP-I nasal irrigation at a concentration of 0.6%. Arm-4 (intervention group): will receive PVP-I nasal spray (NS) at a concentration of 0.5%. Arm-5 (intervention group): will receive PVP-I nasal spray at a concentration of 0.6%. Arm-6 (placebo comparator group): will receive distilled water through NI Arm-7 (Placebo comparator group): will receive distilled water through NS The intervention arms will be compared to the placebo comparator arms. Other supportive and routine care will be the same in both groups. MAIN OUTCOMES: The primary outcome is the proportion of cases that remain COVID-19 positive following the intervention. It will be assessed from 1 minutes to 15 minutes after the intervention. Any occurrence of adverse effects following the intervention will be documented as a secondary outcome. RANDOMIZATION: The assignment to the study (intervention) or control (comparator) group will be allocated in equal numbers through randomization using random number generation in Microsoft Excel by a statistician who is not involved in the trial. The allocation scheme will be made by an independent statistician using a sealed envelope. The participants will be allocated immediately after the eligibility assessment and consenting procedures. BLINDING (MASKING): This is an open-label clinical trial, and no blinding or masking will be performed. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): A total of 189 confirmed cases of COVID-19 will be randomized into seven groups. In each arm, a total of 27 participants will be recruited. TRIAL STATUS: The current trial protocol is Version 1.5 from September 10, 2020. Recruitment began September 30, 2020 and is anticipated to be completed, including data analysis by February 28, 2021. TRIAL REGISTRATION: The trial protocol has been registered in the ClinicalTrials.gov on September 16, 2020. NCT Identifier number: NCT04549376 . FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.