BACKGROUND: Currently, there is no proven effective therapy nor vaccine for the treatment of SARS-CoV-2. Evidence regarding the potential benefit of early administration of hydroxychloroquine (HCQ) therapy in symptomatic patients with Coronavirus Disease (COVID-19) is not clear. METHODS: This observational prospective cohort study took place in 238 ambulatory fever clinics in Saudi Arabia, which followed the Ministry of Health (MOH) COVID-19 treatment guideline. This guideline included multiple treatment options for COVID-19 based on the best available evidence at the time, among which was Hydroxychloroquine (HCQ). Patients with confirmed COVD-19 (by reverse transcriptase polymerase chain reaction (PCR) test) who presented to these clinics with mild to moderate symptoms during the period from 5-26 June 2020 were included in this study. Our study looked at those who received HCQ-based therapy along with supportive care (SC) and compared them to patients who received SC alone. The primary outcome was hospital admission within 28-days of presentation. The secondary outcome was a composite of intensive care admission (ICU) and/or mortality during the follow-up period. Outcome data were assessed through a follow-up telephonic questionnaire at day 28 and were further verified with national hospitalisation and mortality registries. Multiple logistic regression model was used to control for prespecified confounders. RESULTS: Of the 7,892 symptomatic PCR-confirmed COVID-19 patients who visited the ambulatory fever clinics during the study period, 5,541 had verified clinical outcomes at day 28 (1,817 patients in the HCQ group vs 3,724 in the SC group). At baseline, patients who received HCQ therapy were more likely to be males who did not have hypertension or chronic lung disease compared to the SC group. No major differences were noted regarding other comorbid conditions. All patients were presenting with active complaints; however, the HCQ groups had higher rates of symptoms compared to the SC group (fever: 84% vs 66.3, headache: 49.8 vs 37.4, cough: 44.5 vs 35.6, respectively). Early HCQ-based therapy was associated with a lower hospital admission within 28-days compared to SC alone (9.4% compared to 16.6%, RRR 43%, p-value <0.001). The composite outcome of ICU admission and/or mortality at 28-days was also lower in the HCQ group compared to the SC (1.2% compared to 2.6%, RRR 54%, p-value 0.001). Adjusting for age, gender, and major comorbid conditions, a multivariate logistic regression model showed a decrease in the odds of hospitalisation in patients who received HCQ compared to SC alone (adjusted OR 0.57 [95% CI 0.47-0.69], p-value <0.001). The composite outcome of ICU admission and/or mortality was also lower for the HCQ group compared to the SC group controlling for potential confounders (adjusted OR 0.55 [95% CI 0.34-0.91], p-value 0.019). CONCLUSION: Early intervention with HCQ-based therapy in patients with mild to moderate symptoms at presentation is associated with lower adverse clinical outcomes among COVID-19 patients, including hospital admissions, ICU admission, and/or death.

Objectives: To determine the association between comorbidities and the severity of the disease among COVID-19 patients. Methods: We searched the Cochrane, Medline, Trip, and EMBASE databases from 2019. The review included all available studies of COVID-19 patients published in the English language and studied the clinical characteristics, comorbidities, and disease outcomes from the beginning of the pandemic. Two authors extracted studies characteristics and the risk of bias. Odds ratio (OR) was used to analyze the data with 95% confidence interval (CI). Results: The review included 1,885 COVID-19 patients from 7 observational studies with some degree of bias risk and substantial heterogeneity. A significant association was recorded between COVID-19 severity and the following variables: male (OR= 1.60, 95%CI= 1.05 - 2.43); current smoker (OR=2.06, 95%CI= 1.08 - 3.94); and the presence of comorbidities including hypertension (OR=2.05, 95%CI= 1.56 - 2.70), diabetes (OR=2.46, 95%CI= 1.53 - 3.96), coronary heart disease (OR=4.10, 95%CI= 2.36 - 7.12), chronic kidney disease (OR=4.06, 95%CI= 1.45 - 11.35), and cancer (OR=2.28, 95%CI= 1.08 - 4.81). Conclusions: Comorbidities among COVID-19 patients may contribute to increasing their susceptibility to severe illness. The identification of these potential risk factors could help reduce mortality by identifying patients with poor prognosis at an early stage.

Background Several reports have been published about the impact of coronavirus disease 2019 (COVID-19) vaccines on human health, and each vaccine has a different safety and efficacy profile. The aim of this study was to reveal the nature and classification of reported adverse drug reactions (ADRs) of the two COVID-19 vaccines (tozinameran and ChAdOx1) among citizens and residents living in Saudi Arabia, and show possible differences between the two vaccines and the differences between each batch on the health of populations. Methods A cross-sectional study was conducted in Saudi Arabia between December 2020 and March 2021. Saudi citizens and residents aged ≥ 16 years who had at least one dose of any batch of either of the two approved COVID-19 vaccines (tozinameran and ChAdOx1) and who reported at least one ADR from the vaccines were included. The study excluded people who reported ADRs after receiving tozinameran or ChAdOx1 vaccines but no information was provided about the vaccine’s batch number. Results During the study period, 12,868 vaccinated people, including a high-risk group (i.e., those with chronic illness or pregnant women), reported COVID-19 vaccine ADRs that had been documented in the General Directorate of Medical Consultations, Saudi Ministry of Health. The study reported several ADRs associated with COVID-19 vaccines, with the most common (> 25%) being fever/chills, general pain/weakness, headache, and injection site reactions. Among healthy and high-risk people, the median onset of all reported ADRs for tozinameran and ChAdOx1 vaccine batches were 1.96 and 1.64 days, respectively ( p < 0.01). Furthermore, significant differences ( p < 0.05) were recorded between the two studied vaccines in regard to fever/chills, gastrointestinal symptoms, headache, general pain/weakness, and neurological symptoms, with higher incidence rates of these ADRs observed with the ChAdOx1 vaccine than the tozinameran vaccine. However, the tozinameran vaccine was found to cause significantly ( p < 0.05) more palpitation, blood pressure variations, upper respiratory tract symptoms, lymph node swelling, and other unspecified ADRs than the ChAdOx1 vaccine. Among patients vaccinated with seven different batches of the tozinameran vaccine, people vaccinated with the T4 and T5 batches reported the most ADRs. Conclusion There were significant differences regarding most of the reported ADRs and their onset among tozinameran and ChAdOx1 vaccines on both healthy people and high-risk individuals living in Saudi Arabia. Moreover, the study found that the frequencies of most listed ADRs were statistically different when seven batches of tozinameran vaccine were compared.

Aim Post-COVID-19 syndrome is defined as continuous symptoms related to SARS-CoV-2 infection, which can persist for several weeks or months. Previous studies identified risk factors associated with post-COVID-19 syndrome, including female sex, hypertension, and allergic respiratory diseases. This study aims to investigate the frequency of this syndrome among Arabic patients. Subject and methods A cross-sectional study was conducted from March to August 2022. The study included 520 Arabic patients with confirmed COVID-19 diagnosis, who were asked about possible symptoms persisting for ≥28 days. Results Twenty-five percent (25%) of the included patients developed post-COVID-19 syndrome. The most common recorded symptoms were cough (32%), anosmia (32%), fatigue (28%), headache (19%), muscle pain (19%), and shortness of breath (17%). It was found that female sex, hospitalization due to initial COVID-19 infection, and the presence of chronic diseases were significant risk factors for developing post-COVID-19 syndrome. Conclusion The study recorded post-COVID-19 syndrome among 25% of Arabic participants. Initial COVID-19 hospitalization, initial symptomatic COVID-19, and female sex were significant risk factors for developing post-COVID-19 syndrome. Supplementary Information The online version contains supplementary material available at 10.1007/s10389-022-01802-3.

Highlights This study is the first conducted national study in Saudi Arabia discussing the safety outcome of hydroxychloroquine during COVID-19 pandemic. Data were always cross-matched with national database across the Kingdom of Saudi Arabia. The study targeted outpatients setting and patients with mild to moderate cases of COVID-19. Not in hospitalised patients. Results showed that hydroxychloroquine was well tolerated and with very minimum adverse effects among patients when used under a similar protocol to current work. Cardiac related adverse events were very minimal, which might answer raised safety issues in the international medical community.

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Background The global threat of COVID-19 caused by the SARS-CoV-2 virus has reached a high level and the outbreak has been declared as a pandemic. This disease affects different organs and systems including the central nervous system. In this study, we aimed to clarify the development of neurological complications in patients with COVID-19 and the factors associated with these conditions. Methodology Two authors independently searched the Cochrane, Trip, EMBASE, and Google Scholar databases from January 2020 to February 2021. The literature search included studies written in English and related to neurological complications in COVID-19 patients. Then, the two authors independently determined the characteristics and risk of bias of the included studies. Finally, we analyzed the data using odds ratios (ORs) or mean differences (MDs) and 95% confidence intervals (CIs). Results This review involved 4401 patients with COVID-19 from six observational studies. Overall, low to moderate heterogeneity was recorded among the included studies. A high risk of bias was not detected in any of the domains studied, although there were some low risks of bias and heterogeneity. Of the included patients, 8.24% developed neurological manifestations, including delirium (84.3%), myalgia (44.8%), headache (37.7%), encephalopathy (31.8%), dizziness (29.7%), dysgeusia (15.9%), anosmia (11.45), acute ischemic stroke (4.6%), cerebrovascular disease (1.78%), and intracerebral hemorrhage (0.5%). The severity of COVID-19 and the association of underlying comorbidity (predominantly hypertension) increased the risk of neurological complications among COVID-19 patients by fourfold (OR 4.30, CI 2.54–7.29 and OR 4.01, CI 1.05–15.36, respectively). Patients with heart diseases, diabetes, and dyslipidemia had a twofold higher risk of developing neurological complications (OR 2.53, CI 1.01–6.33; OR 2.31, CI 1.15–4.65; and OR 2.13, CI 1.52–3.00, respectively). Conclusion Our analysis indicated that neurological complications were uncommon in patients with COVID-19. Age, male sex, smoking, the severity of disease, and underlying comorbidity, including hypertension, heart disease, diabetes, and dyslipidemia, were identified as significant risk factors for neurological complications in COVID-19 patients.

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