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1.
Blood ; 136(Supplement 1):42-43, 2020.
Article in English | PMC | ID: covidwho-1338981

ABSTRACT

IntroductionCoronavirus disease (COVID-19) pandemic has started to affect Saudi Arabia in the beginning of March 2020 and is expected to cause significant morbidity to many patients, especially to elderly, who might require intensive care unit (ICU) support to survive as its lethality increases with the increasing age. Recent publications suggested the benefit of utilizing convalescent plasma from recovered donors as a therapeutic approach in treating COVID-19 patients. Convalescent plasma could provide our first-line defense for people with COVID-19, especially those who are older and at a much higher risk for complications., therefore, we developed a national protocol to investigate the safety, benefit and applicability at larger scale and at different health care facilities in Saudi Arabia (KSA).ObjectivesPrimary endpoints are1. ICU (or designated area for critical patients) length of stay2. Safety of convalescent plasma>Secondary endpoints included:1. 30 days mortality2. Number of days on mechanical ventilation3. Days to clinical recoveryMethodEligible convalescent plasma donors will be invited to participate in trial. The arrangement for plasmapheresis will start after obtaining donor informed consent. The collected plasma will be treated with pathogen reduction system. The convalescent plasma units will be labelled, stored and shipped as per the standard transfusion medicine protocols. It will be used only for eligible patients' "recipients" as per the following eligibility criteria:1. Inclusion criteria:- Confirmed case of SARS-CoV-2 infection with POSITIVE rRT PCR test-18 or older-Must have been requiring ICU care or severe or immediately life-threatening care (any one of the following):1. Patient requiring ICU care/admission.2. Severe disease is defined as:a. Dyspneab. Respiratory frequency ≥ 30/minc. Blood oxygen saturation ≤ 93%d. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300, and/or Lung infiltrates >50% within 24 to 48 hours3. Life-threatening disease is defined as:a. Respiratory failureb. Septic shock, and/orc.Multiple organ dysfunction or failureExclusion criteria:1. Negative or non-conclusive test COVID-19 rRT PCR test2. Mild symptoms3. Hospitalization not requiring ICU care/admissionEligible Patients will be infused with the convalescent plasma (200-400 ml / treatment dose)at least once & if possible, daily, for up to 5 sessions. Other supportive and therapeutic measures should continue according to the locally approved protocols with due diligence.Sample size was calculated with 80% power and 5% level of significance based on the recently published data to detect statistical difference in the study outcome. Therefore, we plan to recruit total of 575 patients.Convalescent plasma Recipient Group: 115 patients (recipients) who have COVID 19 as per the inclusion criteria.Comparative control Group: 460 Patients who are eitherCOVID 19 historical control or only consent for sharing their clinical and laboratory dataMatching for age, gender, Hypertension, Diabetes and intubation status were done based on the propensity score. Continuous variables will be presented as the median and interquartile range (IQR). Statistical software SPSS 24.0 will be used. Demographic, Clinical, imaging and laboratory information of all enrolled patients will be retrieved from the hospital electronic/paper records system to be used for the outcomes analysis.Results22 sites across KSA that participated in the study. Tertiary, secondary, academic and non-academic centers participated (real world data). There were no unusual safety issues related to convalescent plasma infusion since all mortalities in the plasma group were not related to plasma infusion which represent similar finding from other the published international reports. Keeping in-mind that our data is still maturing, 30 survival probability in the plasma group was 69% compared to 56% in the comparative group (p value = 0.066) (figure-1). This benefit to seem to be more noticeable in the COVID-19 cases who did not meet he criteria for life-threatening disease (figure-2).ConclusionOur study supports the safety of convalescent plasma in treating COVID-19 patients. Patients who are in the category of life-threating/end organs failure do not seem to benefit. There might be a benefit in the other subgroups.

3.
Saudi J Med Med Sci ; 9(1): 16-23, 2021.
Article in English | MEDLINE | ID: covidwho-1027809

ABSTRACT

OBJECTIVE: To present the interim findings from a national study investigating the safety and efficacy of convalescent plasma (CP) containing detectable IgG antibodies as a treatment strategy for severe coronavirus disease 2019 (COVID-19). TRIAL DESIGN AND PARTICIPANTS: An open label, two-arm, phase-II clinical trial conducted across 22 hospitals from Saudi Arabia. The intervention group included 40 adults (aged ≥18 years) with confirmed severe COVID-19 and the control group included 124 patients matched using propensity score for age, gender, intubation status, and history of diabetes and/or hypertension. Intervention group included those (a) with severe symptoms (dyspnea; respiratory rate, ≥30/min; SpO2, ≤93%, PaO2/FiO2 ratio, <300; and/or lung infiltrates >50% within 24-48 h), (b) requiring intensive care unit (ICU) care or (c) experiencing life-threatening conditions. The control group included confirmed severe COVID-19 patients of similar characteristics who did not consent for CP infusion or were not able to receive CP due to its nonavailability. INTERVENTIONS: The intervention group participants were infused 300 ml (200-400 ml/treatment dose) CP at least once, and if required, daily for up to 5 sessions, along with receiving the best standard of care. The control group only received the best standard of care. OUTCOMES: The primary endpoints were safety and ICU length of stay (LOS). The secondary endpoints included 30-day mortality, days on mechanical ventilation and days to clinical recovery. RESULTS: CP transfusion did not result in any adverse effects. There was no difference in the ICU LOS (median 8 days in both groups). The mortality risk was lower in the CP group: 13% absolute risk reduction (P = 0.147), hazard ratio (95% confidence interval): 0.554 (0.299-1.027; P = 0.061) by log-rank test. There was no significant difference in the days on mechanical ventilation and days to clinical recovery. CONCLUSION: CP containing detectable antibodies is a safe strategy and may result in a decrease in mortality in patients with severe COVID-19. The results of the completed trial with a larger study sample would provide more clarity if this difference in mortality is significant. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04347681; Saudi Clinical Trials Registry No.: 20041102.

4.
JMIR Res Protoc ; 9(10): e23543, 2020 Oct 02.
Article in English | MEDLINE | ID: covidwho-863017

ABSTRACT

BACKGROUND: The COVID-19 pandemic is expected to cause significant morbidity and mortality. The development of an effective vaccine will take several months to become available, and its affordability is unpredictable. Transfusion of convalescent plasma (CP) may provide passive immunity. Based on initial data from China, a group of hematologists, infectious disease specialists, and intensivists drafted this protocol in March 2020. OBJECTIVE: The aim of this study is to test the feasibility, safety, and efficacy of CP in treating patients with COVID-19 across Saudi Arabia. METHODS: Eligible patients with COVID-19 will be recruited for CP infusion according to the inclusion criteria. As COVID-19 has proven to be a moving target as far as its management is concerned, we will use current definitions according to the Ministry of Health (MOH) guidelines for diagnosis, treatment, and recovery. All CP recipients will receive supportive management including all available recommended therapies according to the available MOH guidelines. Eligible CP donors will be patients with COVID-19 who have fully recovered from their disease according to MOH recovery criteria as detailed in the inclusion criteria. CP donors have to qualify as blood donors according to MOH regulations except for the history of COVID-19 in the recent past. We will also test the CP donors for the presence of SARS-CoV-2 antibodies by a rapid test, and aliquots will be archived for future antibody titration. Due to the perceived benefit of CP, randomization was not considered. However, we will compare the outcome of the cohort treated with CP with those who did not receive CP due to a lack of consent or lack of availability. In this national collaborative study, there is a likelihood of not finding exactly matched control group patients. Hence, we plan to perform a propensity score matching of the CP recipients with the comparator group patients for the major characteristics. We plan to collect demographic, clinical, and laboratory characteristics of both groups and compare the outcomes. A total sample size of 575 patients, 115 CP recipients and 460 matched controls (1:4 ratio), will be sufficient to detect a clinically important hospital stay and 30-day mortality difference between the two groups with 80% power and a 5% level of significance. RESULTS: At present, patient recruitment is still ongoing, and the interim analysis of the first 40 patients will be shared soon. CONCLUSIONS: In this paper, we present a protocol for a national collaborative multicenter phase II study in Saudi Arabia for assessing the feasibility, safety, and potential efficacy of CP in treating patients with severe COVID-19. We plan to publish an interim report of the first 40 CP recipients and their matched comparators soon. TRIAL REGISTRATION: ClinicalTrials.gov NCT04347681; https://clinicaltrials.gov/ct2/show/NCT04347681. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/23543.

5.
Saudi J Med Med Sci ; 8(3): 227-238, 2020.
Article in English | MEDLINE | ID: covidwho-782280

ABSTRACT

The Saudi Lymphoma Group had previously published recommendations on the management of the major subtypes of lymphoma. However, the effect the currently ongoing coronavirus disease 2019 (COVID-19) pandemic has on the management of patients with lymphoma has been paramount. Therefore, the Saudi Lymphoma Group has decided to provide clinical practice guidelines for the diagnosis, management and follow-up of patients with various types of lymphoma during the COVID-19 pandemic.

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