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result(s) for
"Aziz Jokhdar, Hani A."
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Type I interferon autoantibodies in hospitalized patients with Middle East respiratory syndrome and association with outcomes and treatment effect of interferon beta‐1b in MIRACLE clinical trial
by
Alharbi, Naif Khalaf
,
AlJohani, Sameera
,
Assiri, Abdullah M.
in
Antiretroviral drugs
,
Antiviral drugs
,
Autoantibodies
2023
Background Type I interferons (IFNs) are essential antiviral cytokines induced upon respiratory exposure to coronaviruses. Defects in type I IFN signaling can result in severe disease upon exposure to respiratory viral infection and are associated with worse clinical outcomes. Neutralizing autoantibodies (auto‐Abs) to type I IFNs were reported as a risk factor for life‐threatening COVID‐19, but their presence has not been evaluated in patients with severe Middle East respiratory syndrome (MERS). Methods We evaluated the prevalence of type I IFN auto‐Abs in a cohort of hospitalized patients with MERS who were enrolled in a placebo‐controlled clinical trial for treatment with IFN‐β1b and lopinavir‐ritonavir (MIRACLE trial). Samples were tested for type I IFN auto‐Abs using a multiplex particle‐based assay. Results Among the 62 enrolled patients, 15 (24.2%) were positive for immunoglobulin G auto‐Abs for at least one subtype of type I IFNs. Auto‐Abs positive patients were not different from auto‐Abs negative patients in age, sex, or comorbidities. However, the majority (93.3%) of patients who were auto‐Abs positive were critically ill and admitted to the ICU at the time of enrollment compared to 66% in the auto‐Abs negative patients. The effect of treatment with IFN‐β1b and lopinavir‐ritonavir did not significantly differ between the two groups. Conclusion This study demonstrates the presence of type I IFN auto‐Abs in hospitalized patients with MERS.
Journal Article
Heterogeneity of treatment effect of interferon-β1b and lopinavir–ritonavir in patients with Middle East respiratory syndrome by cytokine levels
by
Al-Dawood, Abdulaziz
,
Alharbi, Naif Khalaf
,
AlJohani, Sameera
in
631/250/127
,
631/250/255
,
Animals
2022
Animal and human data indicate variable effects of interferons in treating coronavirus infections according to inflammatory status and timing of therapy. In this sub-study of the MIRACLE trial (MERS-CoV Infection Treated with a Combination of Lopinavir–Ritonavir and Interferon β-1b), we evaluated the heterogeneity of treatment effect of interferon-β1b and lopinavir–ritonavir versus placebo among hospitalized patients with MERS on 90-day mortality, according to cytokine levels and timing of therapy. We measured plasma levels of 17 cytokines at enrollment and tested the treatment effect on 90-day mortality according to cytokine levels (higher versus lower levels using the upper tertile (67%) as a cutoff point) and time to treatment (≤ 7 days versus > 7 days of symptom onset) using interaction tests. Among 70 included patients, 32 received interferon-β1b and lopinavir–ritonavir and 38 received placebo. Interferon-β1b and lopinavir–ritonavir reduced mortality in patients with lower IL-2, IL-8 and IL-13 plasma concentrations but not in patients with higher levels (p-value for interaction = 0.09, 0.07, and 0.05, respectively) and with early but not late therapy (p = 0.002). There was no statistically significant heterogeneity of treatment effect according to other cytokine levels. Further work is needed to evaluate whether the assessment of inflammatory status can help in identifying patients with MERS who may benefit from interferon-β1b and lopinavir–ritonavir.
Trial registration: This is a sub-study of the MIRACLE trial (ClinicalTrials.gov number, NCT02845843).
Journal Article
Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-β1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial
by
AlJohani, Sameera
,
Aziz Jokhdar, Hani A.
,
Assiri, Abdullah M.
in
Antiretroviral drugs
,
Antiviral
,
Antiviral Agents - adverse effects
2020
The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-β1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-β1b provided with standard supportive care, compared to placebo provided with standard supportive care, in hospitalized patients with laboratory-confirmed MERS. The MIRACLE trial is designed as a recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The aim of this article is to describe the statistical analysis plan for the MIRACLE trial. The primary outcome is 90-day mortality. The primary analysis will follow the intention-to-treat principle. The MIRACLE trial is the first randomized controlled trial for MERS treatment.
Trial registration
ClinicalTrials.gov,
NCT02845843
. Registered on 27 July 2016.
Journal Article
Launching COVID-19 vaccination in Saudi Arabia: Lessons learned, and the way forward
by
El Seoudi, Abdul Aziz
,
Al-Tawfiq, Jaffar A.
,
Almudarra, Sami S.
in
COVID-19
,
COVID-19 Vaccines
,
Humans
2021
The Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV- 2) emerged in Wuhan City, China. The SARS-CoV-2 crossed borders and quickly transformed into a “Public health emergency of international concern”. Countries around the globe are in the race to achieve herd immunity. We describe the steps taken by Saudi Arabia to achieve this goal.
Journal Article
Health risk assessment at mass gatherings: a report of the camel festival in Saudi Arabia
2019
Background: The King Abdel Aziz Camel Festival in Riyadh, Saudi Arabia, aims to showcase the socio-cultural and economic roles of camels in the Middle East, and attracts visitors from many countries in the Region. Aims: Potentially, the gathering of large numbers of people and animals within a specified geographical area during the annual festival has important implications for public safety, health security and legacy. Thus, the Ministry of Health through the Global Center for Mass Gathering Medicine, Saudi Arabia, conducted a health risk assessment for the 2017 Camel Festival. This paper summarizes the risk assessment process and highlights the findings and recommendations of the risk assessment. Methods: Using an all-hazard approach, the Jeddah tool (derived from the World Health Organization Eastern Mediterranean Regional Office's health emergency risk assessment tool) was adapted to conduct the risk assessment. The tool stipulates that risk is directly proportional to the product of hazard magnitude and vulnerability and inversely related to capacity. Results: External causes of morbidity and mortality, such as fires and road traffic accidents, were categorized as high risk hazards. In contrast, brucellosis, foodborne diseases and Middle East Respiratory Syndrome were ranked moderate risk hazards. Rift Valley fever was ranked low risk hazard. Conclusions: The camel festival risk assessment highlights the need for an all-hazard approach to mass gatherings risk assessment. There is a need for multi-sectorial collaboration to strengthen the existing capacity, including disease surveillance.
Journal Article