scholarly journals Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease

2020 ◽  
Author(s):  
Manaf AlQahtani ◽  
Abdulkarim Abdulrahman ◽  
Abdulrahman Almadani ◽  
Salman Yousif Alali ◽  
Alaa Mahmood Al Zamrooni ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Standard Therapy ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Pilot Trial ◽  
Secondary Outcome ◽  
Open Label ◽  
Phase 3 ◽  
Plasma Therapy

AbstractBackgroundConvalescent plasma (CP) therapy in COVID-19 disease has been suggested to improve clinical outcome in severe disease. This pilot study was designed to inform the design of a definitive phase 3 clinical trial.MethodsThis was a prospective, interventional and randomized open label pilot trial involving 40 patients with COVID-19 who were requiring oxygen therapy and who had radiological evidence of pneumonia. Twenty COVID-19 patients received two 200ml transfusions of convalescent patient CP over 24 hours were compared with 20 patients who received routine care alone. The primary outcome was the requirement for ventilation. The secondary outcomes were white blood cell count, lactate dehydrogenase (LDH), C-reactive protein (CRP), Troponin, Ferritin, D-Dimer, procalcitonin, mortality rate at 28 days.ResultsThe CP group were a higher risk group with higher ferritin levels (p<0.05) though respiratory indices did not differ. The primary outcome measure – ventilation – was required in 6 controls and 4 patients on CP (risk ratio 0.67 95% CI 0.22 – 2.0, p=0.72); mean time on ventilation was 10.5 days in the control against 8.2 days in patients on CP (p=0.81). There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm.ConclusionThere were no significant differences in the primary or secondary outcome measures between CP and standard therapy though fewer patients required ventilation and for a shorter period of time. The study showed that CP therapy appears to be safe and it is feasible to perform a definitive phase 3 clinical trial using this study protocol.

scholarly journals Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Manaf AlQahtani ◽  
Abdulkarim Abdulrahman ◽  
Abdulrahman Almadani ◽  
Salman Yousif Alali ◽  
Alaa Mahmood Al Zamrooni ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Pilot Trial ◽  
Standard Of Care ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Open Label ◽  
Plasma Therapy

AbstractConvalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia.Clinical trials registration NCT04356534: 22/04/2020.

A global phase III multicenter, randomized, double-arm, open label trial of ASP-1929 photoimmunotherapy versus physician’s choice standard of care for the treatment of patients with locoregional, recurrent head and neck squamous cell carcinoma (rHNSCC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS6094-TPS6094 ◽  
Author(s):  
Merrill A. Biel ◽  
Ann M. Gillenwater ◽  
David M. Cognetti ◽  
Jennifer Maria Johnson ◽  
Athanassios Argiris ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Light Treatment ◽  
Phase Iii ◽  
Tumor Cell Death ◽  
Open Label ◽  
Combination Drug ◽  
Phase 3 ◽  
Curative Therapy

TPS6094 Background: rHNSCC commonly affects local or regional sites and is associated with considerable morbidity and mortality. Outcomes of these patients remain poor with limited curative treatment options and low response rates. New modalities that are targeted, minimally invasive, and provide improved tumor response and control while having limited systemic side effects are needed. Photoimmunotherapy (PIT) is a new cancer-targeted platform technology. It is a combination drug and device treatment that utilizes monoclonal antibodies conjugated to a dye (IRDye 700DX) that is photoactivated using nonthermal red light to induce rapid and selective tumor cell death. The objective of this phase 3 study is to evaluate the efficacy and safety of ASP-1929 (EGFR-directed antibody cetuximab-IR700 conjugate) PIT treatment as a monotherapy in patients with locoregional rHNSCC. Methods: A global, multicenter phase 3, randomized, double-arm, open-label, controlled trial of ASP-1929 PIT vs physician’s choice standard of care (SOC) for the treatment of locoregional, rHNSCC in patients who have failed or progressed on or after at least two lines of therapy, of which at least one line must be systemic therapy, is currently underway. Primary endpoints of the study are PFS and OS and the key secondary endpoint is ORR. Key inclusion criteria include: disease not amenable to curative therapy; tumor(s) accessible for PIT light treatment and measurable by CT or MRI; male or female ≥ 18 yrs old with life expectancy > 6 months; ECOG score of 0 to 1. Key exclusion criteria include: history of ≥ Grade 3 cetuximab infusion reaction; distant metastatic disease; tumors invading a major blood vessel unless embolized. The study will include ~275 subjects in a 2:1 randomization (ASP-1929 PIT: Physician’s choice SOC). The physician’s choice SOC arm includes cetuximab, methotrexate, or docetaxel. Tumor(s) are illuminated with 690 nm PIT light treatment 24 hrs following completion of ASP-1929 infusion (640 mg/m²). Clinical trial sites will be in the USA, EU and Asia. Clinical trial information: NCT03769506.

scholarly journals Efficacy of Convalescent Plasma Therapy compared to Fresh Frozen Plasma in Severely ill COVID-19 Patients: A Pilot Randomized Controlled Trial

2020 ◽  
Author(s):  
Meenu Bajpai ◽  
Suresh Kumar ◽  
Ashish Maheshwari ◽  
Karan Chhabra ◽  
Pratibha kale ◽  
...  
Keyword(s):  
Virus Disease ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Fresh Frozen Plasma ◽  
Rapid Improvement ◽  
Open Label ◽  
Plasma Therapy ◽  
Link Type ◽  
Fresh Frozen ◽  
Frozen Plasma

AbstractBackgroundThe role of convalescent plasma (COPLA) for the treatment of severely ill Corona Virus Disease-2019 is under investigation. We compared the efficacy and safety of convalescent plasma with fresh frozen plasma (FFP) in severe COVID-19 patients.Methods and findingsThis was an open-label, single-centre phase II RCT on 29 patients with severe COVID-19 from India. One group received COPLA with standard medical care (SMC) (n=14), and another group received FFP with SMC (n=15). A total of 29 patients were randomized in the two treatment groups. Eleven out of 14 (78.5%) patients remained free of ventilation at day seven in the intervention arm while the proportion was 14 out of 15 (93.3 %) in the control arm (p= 0.258). The median reductions in RR per min at 48-hours in COPLA-group and FFP group were -6.5 and -3 respectively [p=0.004] and at day seven were -14.5 and -10 respectively (p=0.008). The median improvements in percentage O2 saturation at 48-hours were 6.5 and 2 respectively [p=0.001] and at day seven were 10 and 7.5 respectively (p=0.026). In the COPLA-group, the median improvement in PaO2/FiO2 was significantly superior to FFP at 48-hours [41.94 and 231.15, p=0.009], and also at day-7 [5.55 and 77.01 p<0.001]. We did not find significant differences in hospitalization duration between the groups (0.08).ConclusionCOPLA therapy resulted in rapid improvement in respiratory parameters and shortened time to clinical recovery, although no significant reduction in mortality was observed in this pilot trial. We need larger trials to draw conclusive evidence on the use of Convalescent plasma in COVID-19. This trial is registered with ClinicalTrial.gov (identifier: NCT04346446).

Pilot, open non-controlled trial to assess the feasibility of implementing objective parameters as primary endpoints in a clinical trial with patients affected by knee osteoarthritis. (Preprint)

2019 ◽  
Author(s):  
Bogdan Corneliu Andor ◽  
Dionisio Franco Barattini ◽  
Dumitru Emanuel Dogaru ◽  
Simone Guadagna ◽  
Serban Rosu
Keyword(s):  
Chondroitin Sulphate ◽  
Controlled Trial ◽  
Subjective Evaluation ◽  
Pilot Trial ◽  
Final Visit ◽  
Life Questionnaire ◽  
Quality Of Data ◽  
Open Label ◽  
Objective Measurements

BACKGROUND Osteoarthritis (OA) is one of the top five most disabling conditions and it affects more than one third of persons over 65 years of age. Currently 80% of persons affected by OA already report having some movement limitation, 20% of people are not be able to perform major activities of daily living, and about 11% of the total affected population need of personal care. On 2014 the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) suggested as first step of pharmacological treatment for knee OA a background therapy with chronic symptomatic slow-acting drugs for osteoarthritis (SYSADOAs), such as glucosamine sulphate, chondroitin sulphate and hyaluronic acid (HA). In studies with oral HA, symptoms of OA are often measured using subjective parameters such as the visual analog scale (VAS) or the quality of life questionnaire (QoL) and objective measurements as ultrasonography (US) or range of motion (ROM) are employed in very few trials. This affects the quality of data in the literature. OBJECTIVE The primary objective of this work is to assess the feasibility of implementing US and ROM as objective measurements to correlate the improvement of knee mobility with pain reduction, evaluated using a subjective scale (VAS) in patients assuming a nutraceutical containing HA. The secondary objective is to evaluate the enrollment rate in one month to verify the feasibility for time and budget of the planned future main study. The explorative objective of the trial is to obtain preliminary data on efficacy of the tested product. METHODS This open-label pilot trial is performed in an orthopedic clinic (Timisoara, Romania). Male and female subjects (from 50 to 70 years) diagnosed with symptomatic OA of the knee with mild joint discomfort for at least 6 months are included. Following protocol, 8 patients are administered for 8 weeks Syalox® 300 Plus (River Pharma, Italy), a product based on HA of high molecular weight. Baseline and final visit assessments include orthopedic assessment, US, Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire, VAS and ROM of knee. RESULTS Data collection occurred between February 2018 and June 2018. All results are expected to be available by the end of 2018. CONCLUSIONS This pilot trial will be the first study to analyze the potential correlation between subjective evaluation (VAS, KOOS questionnaire) and objective measurements (US, ROM and actigraphy). The data from this study will assess the feasibility of the planned monthly recruitment rate and the necessary time and budget, and should provide preliminary information on efficacy of the tested product. CLINICALTRIAL ClinicalTrials.gov (NCT number: NCT03421054).

scholarly journals A randomised controlled trial to examine the effects of cinacalcet on bone and cardiovascular parameters in haemodialysis patients with advanced secondary hyperparathyroidism

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Helen Eddington ◽  
Rajkumar Chinnadurai ◽  
Helen Alderson ◽  
Sara T. Ibrahim ◽  
Constantina Chrysochou ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Secondary Hyperparathyroidism ◽  
Standard Therapy ◽  
Augmentation Index ◽  
Controlled Trial ◽  
Left Ventricular ◽  
Agatston Score ◽  
Open Label ◽  
Mineral And Bone Disorder ◽  
Randomised Controlled

Abstract Background Secondary hyperparathyroidism may lead to increased cardiovascular risk. The use of cinacalcet may improve bone and cardiovascular health with improved parathormone (PTH) and phosphate control. Methods This is an open-label prospective randomised controlled trial to compare progression of cardiovascular and chronic kidney disease mineral and bone disorder (CKD-MBD) parameters. Patients were randomised to receive cinacalcet alongside standard therapy or standard therapy alone. Thirty-six haemodialysis patients who had > 90 days on dialysis, iPTH > 300 pg/mL, calcium > 2.1 mmol/L and age 18–75 years were included. Following randomization, all 36 patients underwent an intensive 12-week period of bone disease management aiming for iPTH 150-300 pg/mL. The primary outcome was change in vascular calcification using CT agatston score. Secondary outcomes included pulse wave velocity (PWV), left ventricular mass index (LVMI), carotid intima-media thickness (CIMT), augmentation index (Aix) and bone measurements. The above measurements were obtained at baseline and 12 months. Results There was no evidence of a group difference in the progression of calcification (median change (IQR) cinacalcet: 488 (0 to1539); standard therapy: 563 (50 to 1214)). In a post hoc analysis combining groups there was a mean (SD) phosphate reduction of 0.3 mmol/L (0.7) and median (IQR) iPTH reduction of 380 pg/mL (− 754, 120). Regression of LVMI and CIMT was seen (P = 0.03 and P = 0.001) and was significantly associated with change of phosphate on multi-factorial analyses. Conclusions With a policy of intense CKD-MBD parameter control, no significant benefit in bone and cardiovascular markers was seen with the addition of cinacalcet to standard therapy over one year. Tight control of hyperphosphataemia and secondary hyperparathyroidism may lead to a reduction in LVMI and CIMT but this needs further investigation. Although the sample size was small, meticulous trial supervision resulted in very few protocol deviations with therapy.

scholarly journals Protocol for a randomised clinical trial of multimodal postconcussion symptom treatment and recovery: the Concussion Essentials study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041458
Author(s):  
Vicki Anderson ◽  
Vanessa C Rausa ◽  
Nicholas Anderson ◽  
Georgia Parkin ◽  
Cathriona Clarke ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Clinical Trial ◽  
Normal Activity ◽  
Secondary Outcome ◽  
Open Label ◽  
Human Research Ethics ◽  
Postconcussive Symptoms ◽  
Study Results ◽  
Registration Number ◽  
Initial Injury

IntroductionWhile most children recover from a concussion shortly after injury, approximately 30% experience persistent postconcussive symptoms (pPCS) beyond 1-month postinjury. Existing research into the treatment of pPCS have evaluated unimodal approaches, despite evidence suggesting that pPCS likely represent an interaction across various symptom clusters. The primary aim of this study is to evaluate the effectiveness of a multimodal, symptom-tailored intervention to accelerate symptom recovery and increase the proportion of children with resolved symptoms at 3 months postconcussion.Methods and analysisIn this open-label, assessor-blinded, randomised clinical trial, children with concussion aged 8–18 years will be recruited from The Royal Children’s Hospital (The RCH) emergency department, or referred by a clinician, within 17 days of initial injury. Based on parent ratings of their child’s PCS at ~10 days postinjury, symptomatic children (≥2 symptoms at least 1-point above those endorsed preinjury) will undergo a baseline assessment at 3 weeks postinjury and randomised into either Concussion Essentials (CE, n=108), a multimodal, interdisciplinary delivered, symptom-tailored treatment involving physiotherapy, psychology and education, or usual care (UC, n=108) study arms. CE participants will receive 1 hour of intervention each week, for up to 8 weeks or until pPCS resolve. A postprogramme assessment will be conducted at 3 months postinjury for all participants. Effectiveness of the CE intervention will be determined by the proportion of participants for whom pPCS have resolved at the postprogramme assessment (primary outcome) relative to the UC group. Secondary outcome analyses will examine whether children receiving CE are more likely to demonstrate resolution of pPCS, earlier return to normal activity, higher quality of life and a lower rate of utilisation of health services, compared with the UC group.Ethics and disseminationEthics were approved by The RCH Human Research Ethics Committee (HREC: 37100). Parent, and for mature minors, participant consent, will be obtained prior to commencement of the trial. Study results will be disseminated at international conferences and international peer-reviewed journals.Trial registration numberACTRN12617000418370; pre-results.

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