Reliable detection of SARS-CoV-2 with patient-collected swabs and saline gargles: A three-headed comparison on multiple molecular platforms.

With increasing demands for SARS-CoV-2 testing, as well as the shortages for testing supplies, collection devices, and trained healthcare workers (HCWs) to collect specimens, self-collection is an attractive prospect to reduce the need for HCWs and expenditure of personal protective equipment. Apart from the traditional nasopharyngeal swab used for SARS-CoV-2 detection, alternative specimens have been validated such as a combined swabs of the oropharynx and anterior nares (OP/N), or throat samples using saline gargles. Both the alternative specimen types are amenable to self-collection. Objectives. This study aimed to compare the sensitivity of HCW-collected (OP/N) swabs, self-collected OP/N swabs, and self-collected saline gargles. Among 38 individuals previously testing positive for SARS-CoV-2 (or their close contacts), two self-collected specimen types (OP/N and saline gargles) were compared to HCW-collected OP/N swabs. SARS-CoV-2 testing was performed on three molecular assays: a laboratory-developed test (LDT), and two commercial assays on automated platforms: Cobas 6800 (Roche Diagnostics) and Panther (Hologic). The sensitivity of self-collected OP/N swabs was equivalent to healthcare worker (HCW)-collected OP/N swabs at 100.0 % [92.6%-100.0%] for all three molecular tests. The sensitivity of saline gargles was not significantly different than HCW-collected OP/N swabs, but varied slightly between instruments at 93.8 % [85.9%-93.8%] for the LDT, 96.8 % [88.6%-96.8%] for the Cobas assay, and 96.7 % [89.2%-96.9%] for the Panther assay. Overall, self-collection using OP/N swabs or saline gargles are reasonable alternatives to HCW-based collections for SARS-CoV-2 detection, and could facilitate broader surveillance strategies.

Tolerability and usability of 0.5% PVP-I gargles and nasal drops in 6692 patients: Observational study.

OBJECTIVES: STUDY DESIGN: Observational study. SETTING: Secondary care ENT Centre. METHODS: All patients attending the hospital for office ENT consultations from 15th April 2020 to 15th September 2020 were included in the study. A total of 6692 office patients were evaluated for feasibility, usability and tolerability of the 0.5% PVP-I gargles and nasal drops. RESULTS: Overall practicability of using 0.5% PVP-I gargles and nasal drops at office level was assessed in terms of feasibility and usability. Feasibility and usability was considered in terms of the ease of the dispensing method of the 0.5% PVP-I gargles and nasal drops by the health care workers to the patients prior to ENT examination. Tolerance was assessed in terms of altered taste, staining of teeth or nasal skin or irritation in the nose. None reported any serious reactions or adverse effects following use of 0.5% PVP-I. CONCLUSION: The study reports the successful feasibility and usability of 0.5% PVP-I gargles and nasal drops and bears the potential to provide benefits in preventing transmission from the patients to the health care workers and vice versa. LEVEL OF EVIDENCE: 4.

A quadruple blind, randomised controlled trial of gargling agents in reducing intraoral viral load among hospitalised COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: 1- To compare the effectiveness of 1% Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline and a novel solution Neem extract (Azardirachta indica) in reducing intra-oral viral load in COVID-19 positive patients. 2- To determine the salivary cytokine profiles of IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ and IL- 17 among COVID-19 patients subjected to 1% Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline or Neem extract (Azardirachta indica) based gargles. TRIAL DESIGN: This will be a parallel group, quadruple blind-randomised controlled pilot trial with an add on laboratory based study. PARTICIPANTS: A non-probability, purposive sampling technique will be followed to identify participants for this study. The clinical trial will be carried out at the Aga Khan University Hospital (AKUH), Karachi, Pakistan. The viral PCR tests will be done at main AKUH clinical laboratories whereas the immunological tests (cytokine analysis) will be done at the Juma research laboratory of AKUH. The inclusion criteria are laboratory-confirmed COVID-19 positive patients, male or female, in the age range of 18-65 years, with mild to moderate disease, already admitted to the AKUH. Subjects with low Glasgow coma score, with a history of radiotherapy or chemotherapy, who are more than 7 days past the onset of COVID- 19 symptoms, or intubated or edentulous patients will be excluded. Patients who are being treated with any form of oral or parenteral antiviral therapy will be excluded, as well as patients with known pre-existing chronic mucosal lesions such as lichen planus. INTERVENTION AND COMPARATOR: Group A (n=10) patients on 10 ml gargle and nasal lavage using 0.2% Povidone-Iodine (Betadiene® by Aviro Health Inc./ Pyodine® by Brooks Pharma Inc.) for 20-30 seconds, thrice daily for 6 days. Group B (n=10) patients will be subjected to 10 ml gargle and nasal lavage using 1% Hydrogen peroxide (HP® by Karachi Chemicals Products Inc./ ActiveOxy® by Boumatic Inc.) for 20-30 seconds, thrice daily for 6 days. Group C will comprised of (n=10) subjects on 10ml gargle and nasal lavage using Neem extract solution (Azardirachta indica) formulated by Karachi University (chemistry department laboratories) for 20-30 seconds, thrice daily for 6 days. Group D (n=10) patients will use 2% hypertonic saline (Plabottle® by Otsuka Inc.) gargle and nasal lavage for a similar time period. Group E (n=10) will serve as positive controls. These will be given simple distilled water gargles and nasal lavage for 20-30 seconds, thrice daily for six days. For nasal lavage, a special douche syringe will be provided to each participant. Its use will be thoroughly explained by the data collection officer. After each use, the patient is asked not to eat, drink, or rinse their mouth for the next 30 minutes. MAIN OUTCOMES: The primary outcome is the reduction in the intra-oral viral load confirmed with real time quantitative PCR. RANDOMISATION: The assignment to the study group/ allocation will be done using the sealed envelope method under the supervision of Clinical Trial Unit (CTU) of Aga Khan University, Karachi, Pakistan. The patients will be randomised to their respective study group (1:1:1:1:1 allocation ratio) immediately after the eligibility assessment and consent administration is done. BLINDING (MASKING): The study will be quadruple-blinded. Patients, intervention provider, outcome assessor and the data collection officer will be blinded. The groups will be labelled as A, B, C, D or E. The codes of the intervention will be kept in lock & key at the CTU and will only be revealed at the end of study or if the study is terminated prematurely. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): As there is no prior work on this research question, so no assumptions for the sample size calculation could be made. The present study will serve as a pilot trial. We intend to study 50 patients in five study groups with 10 patients in each study group. For details, please refer to Fig. 1 for details. TRIAL STATUS: Protocol version is 7.0, approved by the department and institutional ethics committees and clinical trial unit of the university hospital. Recruitment is planned to start as soon as the funding is sanctioned. The total duration of the study is expected to be 6 months i.e. August 2020-January 2021. TRIAL REGISTRATION: This study protocol was registered at www.clinicaltrials.gov on 10 April 2020 NCT04341688 . FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2). Fig. 1 Flow diagram of study-participants' timeline.

Repurposing 0.5% povidone iodine solution in otorhinolaryngology practice in Covid 19 pandemic.

SARS CoV 2 is very much homologous in structure to SARS CoV. Review of literature suggests the in-vitro virucidal action of povidone iodine in SARS CoV and MERS. The oropharynx and nasopharynx are target sites of SARS CoV 2. A significant proportion of COVID 19 sufferers are asymptomatic, but shedding these viral particles, PVP-I has been shown to be a safe therapy when used as a mouthwash or taken nasally or used during ophthalmic surgeries. AIMS: MATERIALS AND METHODS: 0.5% PVP-I solution is prepared from commercially available 10% PVP-I solution. Patients were instructed to put 0.5% PVP-I drops in nose and rinse mouth with gargle prior examinations for 30 s. For endoscopic procedure (nasal and throat) nasal douching and gargling to be started one day prior. Douching and rinsing to be repeated just before procedures. Nasal packing with 0.5% PVP-I along with 4% xylocaine/adrenaline solution, tolerability and any allergic reaction noted. RESULTS: The patient and health care workers tolerated the 0.5%. No allergy was noted. CONCLUSION: We propose the use of 0.5% PVP-I in healthcare workers and their patients to minimise the risk of spread of the disease in addition to the recommended PPE.

Nasopharyngeal wash in preventing and treating upper respiratory tract infections: Could it prevent COVID-19?

Rapid transmission of the severe acute respiratory syndrome coronavirus 2 has led to the novel coronavirus disease 2019 (COVID-19) pandemic. The current emphasis is on preventive strategies such as social distancing, face mask, and hand washing. The technique of nasopharyngeal wash to prevent the virus from inhabiting and replicating in the nasal and pharyngeal mucosa has been suggested to be useful in reducing symptoms, transmission, and viral shedding in cases of viral acute respiratory tract infections. In rapid systematic review, we found studies showing some improvement in prevention and treatment of upper respiratory tract infections. We postulate that hypertonic saline gargles and nasal wash may be useful in prevention and for care of patients with COVID-19. The present evidence emphasizes the need of randomized controlled trials to evaluate the role and mechanism of nasopharyngeal wash in COVID-19.