The ongoing Covid-19 pandemic necessitates measures to prevent transmission and improve patient outcomes. Several studies demonstrated rapid virucidal activity of povidone iodine (PVP-I) against Ebola virus (EBOV), the Middle East Respiratory Syndrome coronavirus (MERS-CoV), influenza virus A (H1N1) and SARS coronavirus (SARS-CoV).
To assess the effectiveness of PVP-I 1% oropharyngeal and intranasal application in COVID 19 positive patients.
1. In reducing disease progression, complications such as respiratory distress / Death, relapse of
infection following discharge.
2. In reducing the transmission to health workers attending to them in quarantine facility and other contacts.
The study is proposed in all district of Andhra Pradesh,India. A two arm parallel group multicentric superiority clinical trial is proposed. COVID-19 positive patients admitted in quarantine and isolation wards attached to hospitals in the state of Andhra Pradesh, India.
Inclusion Criteria: All COVID-19 positive patients aged 18 years and above.
Exclusion Criteria: A known allergy/hypersensitive to Povidone Iodine. Any history of thyroid disorders Unconscious patients; patients on ventilator.
Duration of the Study: 12-16 weeks.
Sample size calculation: It is estimated for a superiority clinical trial of two means (recovery time in days) in a parallel group design with equal allocation. Considering a superiority margin of 5%, mean recovery time in Group I (intervention) as 25 days, SD 16.6 days [Ref: Verity R et al]; mean recovery time of 7 days in Group II (no intervention); significance level set at 5% and power of 80%, the sample size is estimated to be 42 patients in each study group (Group I and Group II). Assuming a response rate of 85%, the sample size for each group is 48.3~ 48 patients. Hence, a total of 96 Covid-19 patients will be enrolled in the study.
Sampling frame will be prepared from the hospital list of COVID-19 patients admitted in the study sites. Eligible patients identified will be enrolled serially until the desired sample size is attained for both groups.
Intervention: Self-administered oropharygeal and nasopharyngeal application of PVP-I 1%,. Procedures will be explained through video recorded demonstration. Minimal contact with patient will be maintained.
Clinical end points: Seroconversion from COVID-19 positive to COVID-19 negative (testing day 7; day 21);.Minimal progression of disease in patients with associated comorbidities.
Recruitment: Mobile numbers will be collected from all COVID-19 positive patients in all the centres. Each participant will be given the participant information sheet (PIS) in the language which they understand and they will also be explained orally, the details of the information sheet. A pre-tested questionnaire in the local language (Telugu) will be administered to primary caregivers of the patients by trained health care personnel. The data regarding age, sex, weight, height, BMI (calculated), travel history, known h/o contact with covid-19 positive patient or any other person with travel history, onset of symptoms such as fever, cough / rhinitis, respiratory symptoms, date of positive report, any associated comorbid factors such as overweight / mild, moderate or severe obesity (as per calculation of BMI), hypertension, diabetes, tuberculosis, asthma or any specific history which participant reveals.
Informed written consent will be individually taken and documented.
Baseline Investigations such as complete Blood picture, RBS, Blood Urea, Sr. Creatinine, C-Reactive protein will be documented. Any additional investigation done for participants with comorbid diseases will also be documented specifically. Baseline Serum Iodine and T3, T4, TSH will be done for all participants. In patients with respiratory symptoms X-ray chest and CT scan will also be taken.
All the health care personnel assigned to the study group-1 will be informed about the study and will also be given training of oropharyngeal gargling and intranasal application of PVP-I 1%. They will be responsible for monitoring the proper use of the PVP-I solution with regard to quantity, technique and frequency. Each COVID-19 positive participant is required to repeat this procedure every 6 hourly i.e (5 AM, 11 AM, 5 PM and 11 PM) which will be also documented in record sheet and electronically. Each healthcare worker and other close contacts of the study group1 participant will also be given option to undertake the same procedure before they come for duty, before and after they leave the premises, after taking their informed written consent too.
Each participant will be followed up telephonically by the member of research group and any change in existing symptoms such as sore throat, fever, respiratory symptoms, diarrhea etc. The status quo or development of any new symptoms will be documented. Any participant showing worsening of symptoms due to disease spread in the form of respiratory distress or lowering of oxygen saturation, loss of consciousness and needing intubation and ventilatory support will be reported, documented and excluded from the study as per the exclusion criteria.
The remaining standard protocol as per the institutional and ICMR guidelines such as wearing of face masks and PPE and standard oral antiviral therapy will be continued and documented.
The disposal of the hazardous material generated will also be treated as per the standard guidelines. The instructions for the same will also be mentioned in the Information brochure.
Study group 2:
Similar details of identifying and collecting the phone numbers of the CoViD 19 positive participants will be done. The data regarding age, sex, weight, height, BMI ( calculated), travel history, known h/o contact with covid-19 positive patient or any other person with travel history onset of symptoms such as fever, cough / rhinitis, respiratory symptoms, date of positive report, any associated comorbid factors such as overweight / mild, moderate or severe obesity (as per calculation of BMI), hypertension, diabetes, tuberculosis, asthma or any specific history which participant reveals.
Baseline Investigations such as complete Blood picture, RBS, Blood Urea, Sr. Creatinine, C reactive protein will be documented. Any additional investigation done for participants with comorbid diseases will also be documented specifically. Baseline Serum Iodine and T3, T4, TSH will be done for all participants. In participant with respiratory symptoms, X-ray chest and CT scan will be also taken .
The routine standard care procedure followed as per the institutions and ICMR guidelines will be continued. No healthcare worker will be encouraged to undertake this proposed prophylaxis