Objective To evaluate whether favipiravir reduces the time to viral clearance as documented by negative SARS-CoV-2 RT-PCR in mild COVID-19 cases compared to placebo. Methods In this randomized, double-blinded, multicenter, and placebo-controlled trial, adults with PCR confirmed mild COVID-19 were recruited in an outpatient setting at seven medical facilities across Saudi Arabia. Participants were randomized in a 1:1 ratio to receive either favipiravir 1800 mg by mouth twice daily on day one followed by 800 mg twice daily (n=112) or a matching placebo (n=119), for a total of 5 to 7 days. The primary outcome was the effect of favipiravir on reducing the time to viral clearance (by PCR test) within 15 days of starting the treatment compared to the placebo group. The trial included the following secondary outcomes: symptom resolution, hospitalization, ICU admissions, adverse events, and 28-day mortality. Results 231 patients were randomized and began the study (median age, 37 [interquartile range: 32-44] years; 155 [67%] men), and 112 (48.5%) were assigned to the treatment group and 119 (51.5%) into the placebo group. The data and safety monitoring board (DSMB) recommended stopping enrollment because of futility at the interim analysis. The median time to viral clearance was 10 (IQR: 6-12) days in the favipiravir group and 8 (IQR: 6-12) days in the placebo group, with a hazard ratio of 0.87 for the favipiravir group (95% CI 0.571 to 1.326; p-value =0.51). The median time to clinical recovery was 7 days (IQR: 4-11) in the favipiravir group and 7 days (IQR: 5-10) in the placebo group. There was no difference between the two groups on the secondary outcome of hospital admission. There were no drug-related severe adverse events. Conclusion In this clinical trial, favipiravir therapy in mild COVID-19 patients did not reduce the time to viral clearance within 15 days of starting the treatment. Clinical Trial Registration ClinicalTrials.gov identifier ( NCT04464408 ): https://clinicaltrials.gov/ct2/show/NCT04464408 .

Background: Serologic testing provides better understanding of SARS-CoV-2 prevalence and its transmission. This study was an investigation of the prevalence of antibodies to SARS-CoV-2 among blood donors in Saudi Arabia. Objective: To estimate the seroprevalence of anti-SARS-CoV-2 antibodies among blood donors in Saudi Arabia during the early phase of the COVID-19 pandemic. Methods: Serology results and epidemiological data were analyzed for 837 adult blood donors, with no confirmed SARS-CoV-2 infection, in Saudi Arabia from 20th to 25th May 2020. Seroprevalence was determined using electrochemical immunoassay to detect anti-SARS-CoV-2 antibodies. Results: The overall seroprevalence of anti-SARS-CoV-2 antibodies was 1.4% (12/837). Non-citizens had higher seroprevalence compared with citizens (OR 13.6, p = 0.001). Secondary education was significantly associated with higher seroprevalence compared with higher education (OR 6.8, p = 0.005). The data showed that the highest seroprevalence was in Makkah (8.1%). Uisng Makkah seroprevalence as the reference, the seroprevalence in other areas was: Madinah 4.1% (OR 0.48, 95% CI 0.12À1.94), Jeddah 2.3% (OR 0.27, 95% CI 0.31À2.25), and Qassim 2.9 % (OR 0.34, 95% CI 0.04À2.89) and these were not statistically different from seroprevalence in the Makkah region. Conclusions: At the early months of the COVID-19 pandemic in Saudi Arabia, the seroprevalence of antibodies to SARS-CoV-2 among blood donors was low, but was higher among non-citizens. These findings may indicate that non-citizens and less educated individuals may be less attentive to preventive measures. Monitoring seroprevalence trends over time require repeated sampling.

A highly accelerating number of people around the world have been infected with novel Coronavirus disease 2019 (COVID-19). Mass screening programs were suggested by the World Health Organization (WHO) as an effective precautionary measure to contain the spread of the virus. On 16 April 2020, a COVID-19 mass screening program was initiated in Saudi Arabia in multiple phases. This study aims to analyze the number of detected COVID-19 cases, their demographic data, and regions most affected in the initial two phases of these mass screening programs. A retrospective cross-sectional study was conducted among the high-risk population as part of the COVID-19 mass screening program across all regions in Saudi Arabia during April and May 2020. A Chi-square-test was used to determine the associations between positive cases and various demographic variables. Out of 71,854 screened individuals, 13.50% (n = 9701) were COVID-19 positive, of which 83.27% (n = 59,835) were males. Among positive cases, in the 30–39 years age group, 6.36% were in the active phase, and 2.19% were in the community phase. Based on our experience, launching mass screening programs is crucial for early case detection, isolation, and pattern recognition for immediate public interventions.

Objectives Coronavirus Disease 2019 (COVID-19) is caused by a new strain of betacoronavirus called SARS-CoV-2, which leads to mild to severe symptoms. Micronutrients in blood serum, namely, zinc, iron, copper, and selenium, play essential roles in the human body’s various organs. This study investigates the association between micronutrient levels and the severity of symptoms in SARS-CoV-2 infected patients. Methods A cross-section study was conducted during June–August 2020 in Riyadh city among 80 patients with confirmed SARS-CoV-2 infection. Within 24 hours of hospital admission, patients have been divided into non-severe and severe cases, and blood samples were drawn from each patient to measure the serum levels of copper, iron “in the form of ferritin,” selenium, and zinc. Results In both study groups, the mean copper and selenium serum levels were within the normal range, while the mean zinc and iron serum levels were elevated. A statistically significant difference was recorded between non-severe and severe cases regarding serum levels of iron and selenium (331.24 vs. 1174.95 ng/ml and 134 vs. 162 mcg/L, respectively, P < 0.0001). On the other hand, no significant difference was detected between both studied groups regarding serum level of zinc and copper (124.57 vs. 116.37 mcq/L and 18.35 vs. 18.2 mcmol/L, respectively, P > 0.05). Conclusions There was a significant elevation of selenium and iron serum levels among severe cases compared to non-severe cases of COVID-19. High levels of iron and selenium could be correlated with the disease severity during infection with SARS-CoV-2.

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.