ABSTRACT
Objective: To evaluate questions asked during the informed consent process by adult participants in a COVID-19 vaccine regulatory study conducted at our center in 2020. Methods: After approval by the IEC, informed consent documents and consent narratives were evaluated. We collated the total number and nature of questions. We then looked at the association between education, gender, socio-economic status, employment status, the language of consent, and number of questions. Between-group comparison (female vs male, unemployed vs employed, primary school vs secondary school vs graduate vs post-graduates, upper vs upper-middle vs middle vs lower middle vs lower) for the number of questions asked was done using univariate analysis followed by multivariate regression analysis with post hoc Tukey's test. Independent variables were gender, employment status, education and socioeconomic status and the dependent variable was the number of questions asked by the participant. All analyses were done at 5% significance. Content analysis was done in addition by creating categories after evaluation and coding them. Results: A total of N = 129 consents from the same number of participants were evaluated. A total of N = 127/129 participants asked at least one question. Sixty-seven percent of participants asked questions related to the study procedure, followed by 44.9% of participants who asked questions related to the safety of vaccine or placebo. A total of N = 295 questions were asked by the 127 participants. In content analysis, 149/295 (50.5%) questions were on study-related procedures followed by one quarter 76/295 (25.8%) based on safety associated with Investigational Product. Very few participants [2.4%] asked about post-trial access as the regulatory trial was a placebo-controlled trial. None of the independent variables were found to be associated with the number of questions. Conclusion: The majority of the questions asked by the participants were about study-related procedures and vaccine safety. No association was found between any of the independent variables and the number of questions asked. However, there were differences in the demographics of the trial participants between the pandemic and pre-pandemic era.
ABSTRACT
BACKGROUND AND RATIONALE: The government guidance regarding COVID-19 vaccination lists food allergy, drug allergy and history of anaphylaxis as contraindications for receiving vaccination. This study was planned to evaluate such patients listed in the database of an allergy center and who took any COVID-19 vaccine. METHODS: Data on n=255 patients was mined. Inclusions were those over 18 years, any allergic diathesis and receipt of at least one dose of any COVID-19 vaccine. Age, gender, nature of allergy and type of COVID vaccine taken along with outcome of interest [occurrence or otherwise of all allergic reaction post vaccination] was collated. RESULTS: Data of 227 patients were finally analysed. Eighty one took the first dose and 33 took both doses. None with food and/or drug allergy and/or a history of anaphylaxis developed any adverse event (AE) post vaccination. Three AEs were seen in those with other allergic diathesis. Two AEs [One to COVAXIN TM and one to COVISHIELD TM] were only generalized itching that were self-limiting. A female patient had itching with palmar erythema [post COVISHIELD TM] which subsided after a week's treatment with an antihistamine. She had a history of allergy to radiocontrast media containing polyethylene glycol/PEG] indicating possible allergy to polysorbate 80 [PEG related compound contained in COVISHIELD TM]. CONCLUSION: No patient fitting contraindications for COVID-19 vaccination laid down by the Indian government developed any allergic reaction post vaccination. The guidelines for vaccination may be revisited to make them more inclusive with appropriate training of the vaccination centre staff.
ABSTRACT
Background and Rationale: The government guidance regarding COVID-19 vaccination lists food allergy, drug allergy and history of anaphylaxis as contraindications for receiving vaccination. This study was planned to evaluate such patients listed in the database of an allergy center and who took any COVID-19 vaccine. Methods: Data on n=255 patients was mined. Inclusions were those over 18 years, any allergic diathesis and receipt of at least one dose of any COVID-19 vaccine. Age, gender, nature of allergy and type of COVID vaccine taken along with outcome of interest [occurrence or otherwise of all allergic reaction post vaccination] was collated. Results: Data of 227 patients were finally analysed. Eighty one took the first dose and 33 took both doses. None with food and/or drug allergy and/or a history of anaphylaxis developed any adverse event (AE) post vaccination. Three AEs were seen in those with other allergic diathesis. Two AEs [One to COVAXIN™ and one to COVISHIELD™] were only generalized itching that were self-limiting. A female patient had itching with palmar erythema [post COVISHIELD™] which subsided after a week's treatment with an antihistamine. She had a history of allergy to radiocontrast media containing polyethylene glycol/PEG] indicating possible allergy to polysorbate 80 [PEG related compound contained in COVISHIELD™]. Conclusion: No patient fitting contraindications for COVID-19 vaccination laid down by the Indian government developed any allergic reaction post vaccination. The guidelines for vaccination may be revisited to make them more inclusive with appropriate training of the vaccination centre staff. © 2021 Journal of Association of Physicians of India. All rights reserved.
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Objective: To evaluate nature of COVID-19 studies registered with Clinical Trials Registry of India [CTRI]. Methods: An audit of all studies registered between March 2020 and January 2021 was done. We mined www.ctri.nic.in with keywords- 'COVID-19, SARS CoV2 and corona virus'. The variables considered for analysis were total number of studies, nature of study (interventional/observational), type (Allopathy/AYUSH/ Miscellaneous), source of funding (Pharmaceutical Industry/Government/ Institute/Self-funded), site (national/multinational and states in India), health category (patient/healthy human volunteer) and duration of the study. The comparison between the medicinal systems was done using the ANOVA. All analysis were done at 5% significance. Results: A total of N=1071 COVID-19 studies were registered. More than half were from the Miscellaneous category [for example behavioral, questionnaire-based studies]. A fourth of registered studies were from AYUSH followed by Allopathy which accounted for a fifth. Observational and interventional studies accounted for approximately 50% each of the total studies with the bulk belonging to the miscellaneous category. Amongst interventional studies, half were from AYUSH. Approximately 41% of these were funded by Ministry of AYUSH. A statistically significant difference was seen between the three medicinal systems [p <0.01]. Maximum studies were registered from Maharashtra (16%). Conclusion: Majority studies were registered from May to August 2020 and from Maharashtra. The AYUSH studies were maximally registered and their findings need to be urgently disseminated to guide policy for the country. © 2021 Journal of Association of Physicians of India. All rights reserved.
ABSTRACT
Objectives: We evaluated the extent of consent declines and consent withdrawals during the COVID-19 pandemic as seen in published randomized controlled trials (RCTs) and compared it with non-COVID-19 RCTs published at the same time and two historical controls. Methods: PubMed/Medline only was searched using key-word "COVID-19" and "RCTs" separately, and filtered for COVID-19 RCTs and non-COVID-19 RCTs respectively, published during a nine-month period (1 Feb - 1 Nov 2020). Exclusions were study protocols, observational studies, interim analysis of RCT data and RCTs with missing data. Primary outcome measures were the proportion of consent declines and consent withdrawals as percentage of total participants screened and randomized respectively in COVID-19 RCTs. We compared consent declines and consent withdrawals of COVID-19 RCTs with non-COVID-19 RCTs and two earlier studies on the same topic that served as historical controls (non-pandemic setting). Results: The search yielded a total of 111 COVID-19 RCTs and 49 non-COVID-19 RCTs. Of these, 39 (35.13%) COVID-19 RCTs and 11 (22.45%) non-COVID-19 RCTs were finally analysed. A total of 770/17759 (4.3%) consent declines and 100/7607 (1.31%) consent withdrawals were seen in 39 COVID-19 RCTs. A significant difference was observed in consent declines between COVID-19 vs non-COVID-19 RCTs [4.3% vs 11.9%, p < 0.0001] and between COVID-19 RCTs vs two historical controls [(4.3% vs 8.6%, p < 0.0001) and (4.3% vs 21.1%, p < 0.0001), respectively]. Conclusion: RCTs conducted during the COVID-19 pandemic appear to have significantly lower consent declines relative to non-COVID-19 RCTs during pandemic and RCTs conducted in non-pandemic settings.