Abstract 5: CT Perfusion is Not a Treatment Effect Modifier for Mechanical Thrombectomy in the 0-8-Hour-Window: A Pre-Planned Analysis of the RESILIENT Trial

Background: CT perfusion has been increasingly used as a selection tool in acute reperfusion therapies. However, it remains unknown whether its use is associated with a higher treatment benefit in patients undergoing thrombectomy. We sought to evaluate the interaction between imaging selection modalities and treatment effect in the RESILIENT Trial. Methods: RESILIENT was a randomized, prospective, multicenter, controlled trial evaluating the safety, efficacy, and cost-effectiveness of thrombectomy versus medical treatment alone in Brazil. A total of 221 patient were enrolled. The trial showed a strong benefit of thrombectomy (90-day mRS ordinal shift, OR 2.28 95%CI [1.41-3.70]; p=0.001). Key imaging selection criteria included ASPECTS ≥6 on non-contrast CT (NCCT) and the exclusion of malignant collateral profile on CT angiography. The use of automated CT perfusion software (RAPID, IschemaView) was optional but was made available in some centers with the pre-specified plan to compare imaging selection modalities. The primary end-point was the common odds ratio (cOR) of mRs at 90 days (shift analysis) and the main secondary endpoint was the rate of functional independence (mRS 0-2) at 90 days. Ordinal logistic and binary regression analyses with imaging selection modality (NCCT versus CTP) as an interaction term were performed with adjustments for potential confounders including age, baseline NIHSS score, occlusion site, IV tPA use and ASPECTS. A p value < 0.05 was considered statistically significant. Results: CTP was performed in 41% of the thrombectomy group and 45% in the control group. There was no significant difference in the treatment effect size for patients selected on the basis of NCCT and CTA only versus those submitted to CTP in terms of overall functional disability (ordinal mRS shift: aOR: 2.87, 95%CI [1.47-5.61] vs. 2.10, 95%CI [1.01-4.36]; p=0.390) or functional independence (mRS 0-2: aOR: 3.16, 95%CI [1.32-7.57] vs. 2.54 95%CI [0.86-7.49], p=0.40) at 90 days. Conclusion: In a randomized clinical trial of thrombectomy within 8 hours of stroke onset, there was no evidence of difference in the treatment effect size across patients selected with NCCT and CTA alone versus automated CT perfusion software.

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Abstract WMP10: The Role of Intravenous Thrombolysis Before Mechanical Thrombectomy: A Subgroup Analysis of the RESILIENT Trial

Stroke ◽

10.1161/str.51.suppl_1.wmp10 ◽

2020 ◽

Vol 51 (Suppl_1) ◽

Author(s):

Gisele Sampaio Silva ◽

Maramelia Miranda ◽

Felipe Barros ◽

Michel Frudit ◽

Octavio Pontes-Neto ◽

...

Keyword(s):

Effect Size ◽

Functional Disability ◽

Mechanical Thrombectomy ◽

Controlled Trial ◽

Intravenous Thrombolysis ◽

Functional Independence ◽

P Value ◽

Significant Difference ◽

Iv Tpa

Background: Mechanical thrombectomy (MT) in addition to intravenous thrombolysis (IVT) is now the recommended treatment for acute ischemic stroke (AIS) patients with large vessel occlusion (LVO). The positive trials also demonstrated that MT alone among patients ineligible for IVT is an effective therapy for AIS. Whether MT alone is as effective, worse, or better than pretreatment with IVT before MT among IVT-eligible AIS patients with LVO is debatable. We aimed to assess the effect of IVT on the clinical outcome of MT in the RESILIENT trial. Methods: RESILIENT was a randomized, prospective, multicenter, controlled trial evaluating the safety, efficacy, and cost-effectiveness of thrombectomy versus medical treatment alone. A total of 221 patient were enrolled. The trial showed a strong benefit to thrombectomy (90-day mRS ordinal shift, OR 95%CI). All eligible patients received intravenous tPA within the 4.5-hour-window. The primary end-point was the common odds ratio (cOR) of mRs at 90 days (shift analysis) and the main secondary endpoint was the rate of functional independence (mRS 0-2) at 90 days. Ordinal logistic and binary regression analyses with the use of intravenous tPA as an interaction term were performed with adjustments for potential confounders including age, baseline NIHSS score, occlusion site, IV tPA use and ASPECTS. A p value < 0.05 was considered statistically significant. Results: Among 221 randomized patients (median NIHSS, 18 IQR [14-21]), 155 (70%) were treated with IV tPA. The frequency of good recanalization (TICI 2b> ) and of hemorrhagic transformation was not affected by IVT. There was no significant difference in the treatment effect size across patients who received intravenous tPA versus those who did not in terms of overall functional disability (ordinal mRS shift: aOR: 2.63, 95%CI [1.48-4.69] vs. 1.54, 95%CI [0.63-3.74]; p=0.42) or functional independence (mRS 0-2: aOR: 3.06, 95%CI [1.37-6.48] vs. 1.71 95%CI [0.55-5.33], p=0.40) at 90 days. Conclusions: The large effect size of MT on LVO outcomes was not significantly affected by IVT. Further studies directly evaluating the role of IVT before MT are of utmost importance.

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Effectiveness of sustained natural apophyseal glides in females with cervicogenic headache: A randomized controlled trial

Journal of Back and Musculoskeletal Rehabilitation ◽

10.3233/bmr-210018 ◽

2021 ◽

pp. 1-7

Author(s):

Muhammad Kashif ◽

Nosheen Manzoor ◽

Rimsha Safdar ◽

Hafsa Khan ◽

Maryam Farooq ◽

...

Keyword(s):

Treatment Group ◽

Controlled Trial ◽

Neck Disability Index ◽

Placebo Treatment ◽

Cervicogenic Headache ◽

Control Group ◽

P Value ◽

Head Positioning ◽

Significant Difference ◽

Neck Disability

BACKGROUND: Cervicogenic headache (CGH) is a common condition that results in significant disability. To treat this dysfunction, Mulligan described sustained natural apophyseal gliders (SNAGs) as a manual therapy approach. However, only inconclusive short-term evidence exists for treating CGH with SNAGs. OBJECTIVE: The present study aims to investigate the effect of SNAGs in the treatment of CGH. METHODS: Fourty female patients ranging from 20 to 40 years with CGH were randomly assigned to two groups: 20 in a treatment group and 20 in a control group. SNAGs were applied to the treatment group while the control group received placebo treatment. Both groups received their respective treatment for 20 minutes, alternately three times per week, for a total of 12 times in four weeks. The outcome measures were the Neck Disability Index (NDI) and the Visual Analogue Scale (VAS). Participants were assessed at baseline and at the end of each week. The data was analyzed using SPSS version 20. Independent t-testing was used to reveal changes between groups. One-way ANOVA was used to determine changes within groups. The level of significance was P< 0.05. RESULTS: Twenty participants (100%) in the treatment group and 17 (85%) in the control group had a history of headache aggravation with active movements or passive head positioning. There was no significant difference at baseline (p> 0.05), indicating that both groups were homogeneous at the time of recruitment. The p value (p< 0.05) showed a significant difference in pain and level of disability at three and four weeks (p< 0.05) in patients treated with SNAGs. However, the cervical range of motion (ROM) showed a statistically significant improvement in flexion and extension in the treatment group (p< 0.05) while there was no significant improvement in side flexion and rotation ROM in both groups (p> 0.05). CONCLUSION: This study found that SNAGs were effective in reducing pain and neck disability and improved ROM in females with CGH.

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Effects of Bupropion on Cognitive Function in Schizophrenia: A Double Blind Randomized Controlled Trial

Global Journal of Health Science ◽

10.5539/gjhs.v9n5p67 ◽

2016 ◽

Vol 9 (5) ◽

pp. 67

Author(s):

Mansoureh Mirzadeh ◽

Najmeh Shahini ◽

Masoud Kashani Lotf Abadi ◽

Maryam Tavakoli ◽

Arash Javanbakht ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Function ◽

Rating Scale ◽

Controlled Trial ◽

Control Group ◽

P Value ◽

Double Blind ◽

Randomized Controlled ◽

Significant Difference ◽

Schizophrenic Patients

Smoking habits are common in schizophrenic patients. Nicotine can suppress negative symptoms and cognitive impairments. The aim of this study was to determine the efficacy of bupropion on cognitive function in schizophrenic patients. This study is a double blind randomized controlled trial in a large referral psychiatric university hospital in Iran. Ninety smoker schizophrenic patients were randomly allocated (based on DSM -IV TR criteria) in two groups (46 patients for case group and 44 patients in control group). They get risperidone up to 6 mg/d and bupropion up to 400 mg/d .clinical assessment (Positive and Negative Syndrome Scale (PANSS), Brief psychiatric rating scale (BPRS) were taken in beginning of study, 14th and 28th days of study. Cognitive assessment (Stroop, Digit Span, and Wechsler, Wisconsin) were taken in begging of study, the days 2nd, 7th, 14th, 28th. All data were analyzed by SPSS Ver. 17 with analytic and descriptive tests. Mean age of patients was 37.66±1.01. Mean duration of disorder was 11.63±.98 years. The scores were significantly lower at the day 28th compared to the beginning of the study in both groups in Wechsler, Stroop color word , Stroop word , Stroop color , BPRS, PANSS p value ≤0.05 .The difference between the two treatments was not significant as indicated by the effect of group, the between-subjects factor p value ≥0.05. In this study, the side effects were examined and there was no significant difference between the two groups p value ≥0.05. Augmentation of bupropion to routine treatment improves cognitive symptoms of schizophrenia in abstinence of tobacco.

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Acupuncture to Treat Primary Dysmenorrhea in Women: A Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1093/ecam/nep239 ◽

2011 ◽

Vol 2011 ◽

pp. 1-11 ◽

Cited By ~ 21

Author(s):

Caroline A. Smith ◽

Caroline A. Crowther ◽

Oswald Petrucco ◽

Justin Beilby ◽

Hannah Dent

Keyword(s):

Randomized Controlled Trial ◽

Treatment Effect ◽

Controlled Trial ◽

Acupuncture Group ◽

Control Group ◽

Primary Dysmenorrhea ◽

Menstrual Pain ◽

Randomized Controlled ◽

Significant Difference

We examined the effectiveness of acupuncture to reduce the severity and intensity of primary dysmenorrhea. A randomized controlled trial compared acupuncture with control acupuncture using a placebo needle. Eligible women were aged 14–25 years with a diagnosis of primary dysmenorrhea. Women received nine sessions of the study treatment over 3 months. The primary outcomes were menstrual pain intensity and duration, overall improvement in dysmenorrhea symptoms and reduced need for additional analgesia, measured at 3, 6 and 12 months from trial entry. A total of 92 women were randomly assigned to the intervention (acupuncture and control ). At 3 months although pain outcomes were lower for women in the acupuncture group compared with the control group, there was no significant difference between groups. Women receiving acupuncture reported a small reduction in mood changes compared with the control group, relative risk (RR) 0.72, 95% confidence interval (CI) 0.53–1.00, . Follow-up at 6 months found a significant reduction in the duration of menstrual pain in the acupuncture group compared with the control group, mean difference –9.6, 95% CI –18.9 to –0.3, , and the need for additional analgesia was significantly lower in the acupuncture group compared with the control group, RR 0.69, 95% CI 0.49–0.96, , but the follow-up at 12 months found lack of treatment effect. To conclude, although acupuncture improved menstrual mood symptoms in women with primary dysmenorrhea during the treatment phase, the trend in the improvement of symptoms during the active phase of treatment, and at 6 and 12 months was non-significant, indicating that a small treatment effect from acupuncture on dysmenorrhea may exist. In the study, acupuncture was acceptable and safe, but further appropriately powered trials are needed before recommendations for clinical practice can be made.

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Atorvastatin in Helicobacter Pylori Treatment: A Randomized Controlled Trial and Review

10.21203/rs.3.rs-575317/v1 ◽

2021 ◽

Author(s):

Mohammad Reza Mohammad Hoseini Azar ◽

Parham Porteghali ◽

Amin Sedokani

Keyword(s):

Helicobacter Pylori ◽

Standard Treatment ◽

Controlled Trial ◽

Intervention Group ◽

Trial Registration ◽

Control Group ◽

P Value ◽

Bismuth Subcitrate ◽

Significant Difference ◽

H Pylori

Abstract Background: Considering the increase in drug resistance over time to Helicobacter pylori treatment relying on the anti-inflammatory and antibacterial effects of atorvastatin to increase the success rate of H. pylori eradication, we examined the effect of adding atorvastatin to standard treatment of H. pylori eradication.Results: A total of 186 symptomatic patients who had been diagnosed with Helicobacter pylori infection and tested for H. pylori eradication were examined by a pathological response or positive urea breath test. Patients who received atorvastatin in addition to standard treatment were also identified based on a table of random numbers. Standard treatment included a 240mg bismuth subcitrate tablet, a 40mg pantoprazole tablet, a 500mg metronidazole tablet, and 2 capsules of 500mg amoxicillin, all taken BID for 14 days. After 4 weeks of treatment, all patients underwent stool testing for H. pylori fecal antigen. If the test was positive, the request was considered a failure of treatment, and if the test was negative, it was considered a successful eradication of H. pylori. The clinical trial registration code for this study is IRCT20190823044589N1. The eradication rate of H. pylori was 80% in the control group and 80.9% in the intervention group, which did not show a statistically significant difference between the two groups (P-value=0.971).Conclusion: Adding atorvastatin to 4-drug regimen of PPI, bismuth subcitrate, amoxicillin, and metronidazole as the first line of treatment for H. pylori eradication is ineffective.Trial registration: IRCT, IRCT20190823044589N1. Registered 28 December 2019 - Retrospectively registered, https://en.irct.ir/trial/41734

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Effects of posterior capsule stretch on adhesive capsulitis.

The Professional Medical Journal ◽

10.29309/tpmj/2019.26.08.3868 ◽

2019 ◽

Vol 26 (08) ◽

pp. 1272-1277

Author(s):

Madiha Maryam ◽

Muhammad Kashif ◽

Abdul Ghafoor Sajjad ◽

Razia Rizwan ◽

Sehrish Ali ◽

...

Keyword(s):

Internal Rotation ◽

Manual Therapy ◽

Functional Disability ◽

Adhesive Capsulitis ◽

Mean Value ◽

Control Group ◽

P Value ◽

Significant Difference ◽

Group A ◽

Group B

To compare the effect of posterior capsular stretch on pain, ROM and functional disability in Adhesive Capsulitis. Study Design: Experimental, Randomized Control Trail. Setting: Department of Physiotherapy, Capital Development Authority Hospital Islamabad. Period: October 2015 to March 2016. Materials and Methods: Forty female patients having aged between 40 to 70 years with freezing and frozen stage of adhesive capsulitis were screened out. Adhesive capsulitis secondary to cervical Spondylosis, osteoporosis, direct trauma and any inflammation were excluded from the study. Subjects were randomly placed into two groups lottery method, the experimental group having 19 subjects received posterior capsular stretch along with conventional manual therapy and electrotherapy whereas the control group had 21 subjects and they were given manual therapy and electrotherapy alone. The Numeric Pain Rating Scale, Shoulder Pain and Disability Index, and Range of Motion of shoulder joint were used as outcome measures. All the patients were assessed at baseline before intervention and at the completion of 6 weeks of treatment. Data was analyzed using SPSS version 20. Results: Abduction, Internal Rotation and disability show significant result. The abduction mean value of Group A was 115.00±22.023and of the Group B was 81.74±20.653 with p value was P<05. The internal rotation mean value of Group A was 70.71±12.776 and for the Group B was 60.32±8.699 and having p value P<05. The SPADI mean value of Group A was 51.76±22.043 and for the Group B was 24.24±7.287 having p value P<05. The NPRS and external rotation showed non-significant difference. Conclusion: It is concluded that posterior capsular stretch along with mobilization is more effective in treating ROM and functional disability.

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EVALUASI INTERVENSI MEDIA BOOKLET TERHADAP TINGKAT PENGETAHUAN DAN KEPATUHAN PASIEN DIABETES MELITUS TIPE 2 DI PUSKESMAS BANJARBARU SELATAN

Jurnal Publikasi Kesehatan Masyarakat Indonesia ◽

10.20527/jpkmi.v6i1.6874 ◽

2019 ◽

Vol 6 (1) ◽

Author(s):

Valentina Meta Srikartika ◽

M. Rasyid Akbar ◽

Herningtyas Nautika Lingga

Keyword(s):

Diabetes Mellitus ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

P Value ◽

Randomized Controlled ◽

Significant Difference ◽

Level Of Knowledge ◽

Diabetes Melitus

ABSTRAKKeberhasilan pengobatan diabetes melitus tidak hanya dipengaruhi oleh kualitas pelayanan kesehatan, keterampilan petugasnya, sikap, dan pola hidup pasien, tetapi dipengaruhi juga oleh kepatuhan pasien terhadap pengobatannya. Tingkat kepatuhan minum obat pasien diabetes mellitus di Indonesia mayoritas masih berada dibawah 50%. Tujuan dari penelitian ini adalah mengukur pengaruh edukasi melalui media booklet terhadap pengetahuan dan kepatuhan pasien diabetes melitus tipe 2. Jenis penelitian yang digunakan adalah Randomized Controlled Trial (RCT). Populasi yang didapat dari penelitian ini sebanyak 40 orang dengan kelompok kontrol 20 orang dan kelompok intervensi 20 orang. Kelompok kontrol merupakan kelompok yang tidak mendapatkan booklet, sedangkan kelompok intervensi adalah kelompok yang mendapatkan booklet sebagi media edukasi. Pengetahuan dan kepatuhan responden diukur melalui kuesioner yang diberikan sebelum (pretest) dan 2 minggu kemudian (posttest). Rata-rata skor pengetahuan dan kepatuhan pre-test dibandingkan dengan skor post-test dengan menggunakan uji Wilcoxon. Berdasarkan hasil analisis, terjadi perbedaan tingkat pengetahuan dan kepatuhan yang signifikan (p value < 0,001) antara sebelum dan sesudah pemberian booklet pada kelompok intervensi dan tidak ada perbedaan yang signifikan pada tingkat pengetahuan (p value = 0,83) dan kepatuhan (p value = 0,317) pada kelompok kontrol. Oleh karena itu, dapat disimpulkan bahwa media booklet dapat meningkatkan tingkat pengetahuan dan kepatuhan pada pasien diabetes melitus.Kata-kata kunci: Diabetes melitus, pengetahuan, kepatuhan, bookletABSTRACTThe success of a treatment of diabetes mellitus is not only influenced by the quality of health services, the skills of its officers, attitudes, and lifestyle of patients, but it is also influenced by patient adherence to treatment. The level of medication compliance among diabetes patients in Indonesia were still below 50%. The purpose of this study was to measure the effect of education through booklet media on the knowledge and compliance of patients with type 2 diabetes mellitus. The type of research used was Randomized Controlled Trial (RCT). The population obtained from this study were 40 people with a control group of 20 people and an intervention group of 20 people. The control group was the group that did not get the booklet, while the intervention group was the group that received the booklet as an educational medium. Knowledge and compliance of respondents was measured through questionnaires given before (pretest) and 2 weeks later (posttest). The average score of knowledge and adherence between pretest and posttest will be compared using Wilcoxon analysis. Based on the results of data analysis with the Wilcoxon test, there was a significant difference in the level of knowledge and compliance (p value < 0.001) between before and after booklet administration in the intervention group and no significant difference in knowledge level (p value = 0.83) and compliance (p value = 0.317) in the control group. It can be concluded that the booklet media can increase the level of knowledge and compliance in diabetes mellitus patients.Keywords: Diabetes mellitus, knowledge, compliance, booklet

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No evidence of effectiveness of mirror therapy early after stroke: an assessor-blinded randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215518824737 ◽

2019 ◽

Vol 33 (5) ◽

pp. 885-893 ◽

Cited By ~ 3

Author(s):

Paola Antoniotti ◽

Laura Veronelli ◽

Antonio Caronni ◽

Alessia Monti ◽

Evdoxia Aristidou ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Upper Limb ◽

Controlled Trial ◽

Intervention Group ◽

Functional Independence ◽

Control Group ◽

Mirror Therapy ◽

Randomized Controlled ◽

Significant Difference ◽

Flexion Extension

Objective: The aim of this study was to investigate the efficacy of mirror therapy on upper-limb recovery in early post-stroke patients. Design: Assessor-blinded randomized controlled trial. Setting: Inpatient rehabilitation clinic. Subjects: A total of 40 patients with upper-limb impairment due to a first-ever ischaemic or haemorrhagic stroke, within four weeks from the cerebrovascular accident. Intervention: The intervention group received mirror therapy, while the control group received sham therapy. During mirror therapy, patients’ sound hand was reflected by a mirror. During sham therapy, an opaque surface replaced the mirror-reflecting surface. Both the mirror therapy and sham therapy groups practised their sound hand with exercises, ranging from the simple elbow flexion–extension to complex tasks (e.g. reaching and grasping). Mirror therapy and sham therapy were added to conventional rehabilitation. Main measures: Primary outcome includes Fugl–Meyer upper extremity scale. Secondary outcomes include action research arm test (ARAT) and functional independence measure (FIM) scale. Outcomes were measured at the beginning (T0) and end (T1) of the treatment. Results: At baseline, both groups (sham therapy vs. mirror therapy; mean (SD)) were comparable for Fugl–Meyer (30.9 (23.9) vs. 28.5 (21.8)), ARAT (25.1 (25.5) vs. 23.5 (24)) and FIM (71.0 (20.6) vs. 72.9 (17.8)) scores. At the end of the treatment, both groups significantly improved in the Fugl–Meyer (40.6 (21.3) vs. 38.3 (23.4)), ARAT (31.9 (23.0) vs. 30 (24.1)) and FIM (100.3 (21.9) vs. 99.4 (22.6)) scores. However, at T1, no significant difference was observed between the sham therapy and mirror therapy groups, neither for the Fugl–Meyer, nor for ARAT and FIM scores. Conclusion: Compared with sham therapy, mirror therapy did not add additional benefit to upper-limb recovery early after stroke.

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EFFECT OF TAMSULOSIN ON STENTRELATED SYMPTOMS

The Professional Medical Journal ◽

10.29309/tpmj/2016.23.01.2443 ◽

2016 ◽

Vol 23 (01) ◽

pp. 114-118

Author(s):

Rana Ata ur Rehman ◽

Muhammad Muzammil Tahir ◽

Muhammad Seerwan

Keyword(s):

Placebo Group ◽

Ureteral Obstruction ◽

Controlled Trial ◽

Ureteral Stent ◽

Control Group ◽

P Value ◽

Routine Practice ◽

Ureteral Stents ◽

Significant Difference ◽

Group 2

Introduction: Cystoscopic intraluminal placement of ureteral stents has become a routine practice in urology. Ureteral stents preserve urine flow from the kidney to the bladder in cases of ureteral obstruction (intrinsic or extrincis). In patients with obvious ureteral obstruction, the placement of a ureteral stent will restart urine transport and protect the kidney from possible risks. Ureteral stents are troublesome in some patients and causes LUTS. Study Design: Prospective randomized controlled trial. Setting: Urology Department, Sheikh Zayed Hospital Lahore. Period: Six month started from August 2015 to December 2015. Material and Methods: 100 patients who were randomly divided into two equal groups. The patients were between 18 to 50 years of age of both gender undergo retrograde double-J ureteral stent placement. Before the double-J stent will be applied, all patients completed an International Prostate Symptom Score (IPSS) questionnaire for evaluation of lower urinary tract symptoms.Patients were divided in two groups on the basis of lottery method tamsolusin group (1) and placebo group (2). Tamsulosin group patients was given tamsulosin post operatively and placebo group was given a placebo postoperatively. Results: There were total 100 patients who were enrolled in this study with a mean age of 42.63±6.24. There were 75(75%) were male while 25(25%) were female. The mean IPSS sore at presentation was 2.47±1.43 and post treatment was 5.20±1.65. There was significant difference in IPSS score in control group with mean 5.28±1.69 versus study as mean 2.22±1.05 group, p-value= 0.010. Conclusion: There is difference in lowering of IPSS score in the patients who are given tamsolusin versus those who were retained on placebo.

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Role of Interferon Therapy in Severe COVID-19: The COVIFERON Randomized Controlled Trial

10.21203/rs.3.rs-136499/v1 ◽

2021 ◽

Author(s):

Ilad Alavi Darazam ◽

Mohamad Amin Pourhoseingholi ◽

Shervin Shokouhi ◽

Seyed Sina Naghibi Irvani ◽

Majid Mokhtari ◽

...

Keyword(s):

Viral Infections ◽

Controlled Trial ◽

Ordinal Scale ◽

Control Group ◽

P Value ◽

Open Label ◽

Subcutaneous Injections ◽

Positive Effects ◽

Significant Difference ◽

Registration Number

Abstract Type 1 Interferons (IFNs) have been associated with positive effects on Coronaviruses. Previous studies point towards the superior potency of IFNβ compared to IFNα against viral infections. We conducted a three-armed, individually-randomized, open-label, controlled trial of IFNβ1a and IFNβ1b, comparing them against each other and a control group. Patients were randomly assigned in a 1:1:1 ratio to IFNβ1a (subcutaneous injections of 12,000 IU on days 1, 3, 6), IFNβ1b (subcutaneous injections of 8,000,000 IU on days 1, 3, 6), or the control group. All three arms orally received Lopinavir/Ritonavir (400mg/100 mg twice a day for ten days) and a single dose of Hydroxychloroquine 400 mg on the first day. Our utilized primary outcome measure was Time To Clinical Improvement (TTCI) defined as the time from enrollment to discharge or a decline of two steps on the clinical seven-step ordinal scale, whichsoever came first. A total of 60 severely ill patients with positive RT-PCR and Chest CT scans underwent randomization (20 patients to each arm). In the Intention-To-Treat population, IFNβ1a was associated with a significant difference against the control group, in the TTCI; (HR; 2.36, 95% CI=1.10-5.17, P-value=0.031) while the IFNβ1b indicated no significant difference compared with the control; HR; 1.42, (95% CI=0•63-3•16, P-value=0•395). The median TTCI for both of the intervention groups was five days vs. seven days for the control group. The mortality was numerically lower in both of the intervention groups (20% in the IFNβ1a group and 30% in the IFNβ1b group vs. 45% in the control group). There were no significant differences between the three arms regarding the adverse events. In patients with laboratory-confirmed SARS-CoV-2 infection, as compared with the base therapeutic regiment, the benefit of a significant reduction in TTCI was observed in the IFNβ1a arm. This finding needs further confirmation in larger studies. Trial Registration Number: ClinicalTrials.gov, NCT04343768. (Submitted: 08/04/2020; First Online: 13/04/2020) (Registration Number: NCT04343768)

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