scholarly journals Safety and Efficacy of Convalescent Plasma to Treat Severe COVID-19: Protocol for the Saudi Collaborative Multicenter Phase II Study (Preprint)

2020 ◽  
Author(s):  
Mohammed Albalawi ◽  
Syed Ziauddin Ahmed Zaidi ◽  
Nawal AlShehry ◽  
Ahmed AlAskar ◽  
Abdul Rehman Zia Zaidi ◽  
...  
Keyword(s):  
Saudi Arabia ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Collaborative Study ◽  
Rapid Test ◽  
Effective Vaccine ◽  
Control Group ◽  
Inclusion Criteria ◽  
Safety And Efficacy ◽  
Multicenter Phase

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. CLINICALTRIAL ClinicalTrials.gov NCT04347681; https://clinicaltrials.gov/ct2/show/NCT04347681 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/23543

scholarly journals Safety and Efficacy of Convalescent Plasma to Treat Severe COVID-19: Protocol for the Saudi Collaborative Multicenter Phase II Study

10.2196/23543 ◽  
2020 ◽  
Vol 9 (10) ◽  
pp. e23543 ◽  
Author(s):  
Mohammed Albalawi ◽  
Syed Ziauddin Ahmed Zaidi ◽  
Nawal AlShehry ◽  
Ahmed AlAskar ◽  
Abdul Rehman Zia Zaidi ◽  
...  
Keyword(s):  
Saudi Arabia ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Collaborative Study ◽  
Rapid Test ◽  
Effective Vaccine ◽  
Control Group ◽  
Inclusion Criteria ◽  
Safety And Efficacy ◽  
Multicenter Phase

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

scholarly journals Safety and Efficacy of Convalescent Plasma for Severe COVID-19: Interim Report of a Multicenter Phase II Study from Saudi Arabia

2021 ◽  
Vol 9 (1) ◽  
pp. 16
Author(s):  
Hani Al-Hashmi ◽  
Nawal AlShehry ◽  
SyedZiauddin A Zaidi ◽  
Ahmed AlAskar ◽  
Abdurahman Al Odayani ◽  
...  
Keyword(s):  
Saudi Arabia ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Interim Report ◽  
Safety And Efficacy ◽  
Multicenter Phase

scholarly journals Safety and Efficacy of Ranibizumab in Diabetic Macular Edema (RESOLVE Study): A 12-month, randomized, controlled, double-masked, multicenter phase II study

Diabetes Care ◽  
2010 ◽  
Vol 33 (11) ◽  
pp. 2399-2405 ◽  
Author(s):  
P. Massin ◽  
F. Bandello ◽  
J. G. Garweg ◽  
L. L. Hansen ◽  
S. P. Harding ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Multicenter Phase

Imatinib mesylate in advanced chordoma: A multicenter phase II study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 10003-10003 ◽  
Author(s):  
S. Stacchiotti ◽  
S. Ferrari ◽  
V. Ferraresi ◽  
G. Grignani ◽  
F. Crippa ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Collaborative Study ◽  
Dose Intensity ◽  
Preliminary Evidence ◽  
Tissue Response ◽  
Single Institution ◽  
Multicenter Phase ◽  
Prospective Phase ◽  
One Year

10003 Background: The antitumor activity of Imatinib in chordoma was preliminarily shown in a compassionate series of 18 pts. This prospective Phase II collaborative study was planned thereafter. Methods: From November 2004 to April 2006, 55 pts with progressing advanced chordoma were enrolled in this Phase II study. Cases were provided by 13 Italian centers and one Swiss. Imatinib was given at the planned dose of 800 mg/day (for a received dose intensity in excess of 600 mg/day), until evidence of progression. Mean age was 59 yrs, (range 24–86); PS 0–3 (=2 in 22%); site of origin was the sacrum in 60%, spine in 25%, skull base in 15%; the disease was metastatic in 43% and localized advanced in 57%. All tumors were positive for PDGFRB/PDGFB. Results: In 44 pts evaluable for antitumor response, 37 (84%) had stable disease as their best RECIST response, which was maintained for more than 6 months in 32, for a clinical benefit rate (CR+PR+SD=6mos) of 73%. In 7 of these SD pts (16%), a degree of objective tumor shrinkage was reported. Centralized radiological review is underway, focusing on non-dimensional, “tissue” response, and results thereof will be presented. In 39 pts who were symptomatic at baseline, subjective improvement of symptoms was claimed by 25 (64%). On ITT analysis, median PFS was 32 wks, with 38% of pts free from progression at one year, and 16% on treatment at 18 months. Most frequent drug-related adverse events were nausea (35%) and vomiting (30%), edema (30%), skin rash (28%), G1–3 anemia (24%), asthenia (17%), G1–3 leucopenia (13%). Conclusions: Preliminary evidence of Imatinib efficacy in chordoma was provided in a single-institution, compassionate setting, and is now confirmed by this multicenter Phase II study. On the basis of these data, an international effort on molecular-targeted therapy with Imatinib in advanced chordoma is warranted. No significant financial relationships to disclose.

Safety and efficacy of PD-1 blockade using pembrolizumab in patients with advanced soft tissue (STS) and bone sarcomas (BS): Results of SARC028—A multicenter phase II study.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. 11006-11006 ◽  
Author(s):  
Hussein Abdul-Hassan Tawbi ◽  
Melissa Amber Burgess ◽  
John Crowley ◽  
Brian Andrew Van Tine ◽  
James Hu ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Safety And Efficacy ◽  
Multicenter Phase ◽  
Bone Sarcomas

scholarly journals Extended safety and efficacy data on S-1 plus cisplatin in patients with untreated, advanced gastric carcinoma in a multicenter phase II study

Cancer ◽  
2007 ◽  
Vol 109 (1) ◽  
pp. 33-40 ◽  
Author(s):  
Heinz-Joseph Lenz ◽  
Fa-Chyi Lee ◽  
Daniel G. Haller ◽  
Deepti Singh ◽  
Al B. Benson ◽  
...  
Keyword(s):  
Gastric Carcinoma ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Efficacy Data ◽  
Safety And Efficacy ◽  
Advanced Gastric Carcinoma ◽  
Multicenter Phase

scholarly journals Safety and efficacy of tenecteplase versus alteplase in patients with acute ischaemic stroke (TRACE): a multicentre, randomised, open label, blinded-endpoint (PROBE) controlled phase II study

2021 ◽  
pp. svn-2021-000978
Author(s):  
Shuya Li ◽  
Yuesong Pan ◽  
Ziran Wang ◽  
Zhigang Liang ◽  
Huisheng Chen ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Phase Ii ◽  
Acute Ischaemic Stroke ◽  
Phase Ii Study ◽  
Chinese Patients ◽  
Tissue Type ◽  
Control Group ◽  
Open Label ◽  
Safety And Efficacy ◽  
Efficacy Profile

BackgroundTenecteplase (TNK) possesses several pharmacological characteristics superior to conventional alteplase (rt-PA), with well-established safety and efficacy profile in Caucasians. There exists controversy over the optimal dose of intravenous rt-PA for East Asians with acute ischaemic stroke (AIS). Current study aimed to determine the safety dose range of recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) for patients with AIS in China.MethodsThis multicentre, prospective, randomised, open-label, blinded end-point, phase II study compared three tiers of 0.1, 0.25, 0.32 mg/kg rhTNK-tPA (to a maximum of 40 mg) with standard 0.9 mg/kg rt-PA (to a maximum of 90 mg) in patients who were eligible for intravenous thrombolysis. The safety outcome were symptomatic intracranial haemorrhage (sICH) within 36 hours.ResultsBetween May 2018 and February 2020, 240 patients were randomly assigned to four group, 4 of whom did not receive study treatment. The intention-to-treat analysis included 236 patients. There was no difference in the improvement on National Institutes of Health Stroke Scale at day 14 in the 3 tiers and control group (63.3%, 77.2%, 66.7% vs 62.7%). The number of sICH was 3 of 60 (5.0%) in the 0.1 mg/kg group, none in the 0.25 mg/kg group, 2 of 60 (3.3%) in the 0.32 mg/kg group and 1 (1.7%) of 59 in the rt-PA group. There were no significant between-group differences in severe adverse events.ConclusionsSimilar to the Caucasians, rhTNK-tPA was well tolerated in Chinese patients with AIS at all doses administered within 3 hours of symptom onset. The dose-efficacy profile of rhTNK-tPA needs to be established with future investigations.Trial registration numberNCT04676659.

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