An Open-Label, Randomized, Parallel, Multi-Center Trial Comparing the Safety and Efficacy of rFVIIa When Administered as I.V. Bolus or I.V. Continuous Infusion to Hemophilia Patients with Inhibitors during and after Surgery.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3975-3975 ◽  
Author(s):  
Rajiv K. Pruthi ◽  
Prasad Mathew ◽  
Leonard A. Valentino ◽  
Stephanie V. Seremetis
Keyword(s):  
Treatment Group ◽  
Adverse Events ◽  
Continuous Infusion ◽  
Hemophilia A ◽  
Multicenter Trial ◽  
Major Surgery ◽  
Control Group ◽  
Current Standard ◽  
Open Label ◽  
Serious Adverse Events

Background and Purpose: Bolus infusion (BI) of recombinant FVIIa (rFVIIa) is effective for the treatment of bleeding and surgical prophylaxis in congenital hemophilia A or B patients with FVIII or IX inhibitors. In principle, continuous infusion (CI) of rFVIIa could maintain the hemostatic effect at a steady state while avoiding the peaks and troughs of repetitive BI. The purpose of this study was to compare the efficacy and safety of rFVIIa CI with rFVIIa BI in major surgery in hemophilia patients with inhibitors. Methods: A 10-day, open-label, randomized, multicenter trial was conducted in hemophilia A or B patients (age > 5 yr) with inhibitors to FVIII or FIX who underwent elective major surgery. Patients received rFVIIa as an initial bolus dose of 90 μg/kg followed by intermittent i.v. bolus (90 μg/kg) or i.v. continuous (50 μg/kg/hr) infusion. BI was administered every 2 hours during surgery and through Day 5, then every 4 hours for Days 6 to 10. CI was administered at 50 μg/kg/hr through Day 5 and at 25 μg/kg/hr Days 6 to10. A third control group of 10 non-inhibitor hemophilia A or B patients who underwent similar surgery and were treated with FVIII or FIX (based on current standard of care and physician’s choice) was assessed to compare adverse event and coagulation profiles. Safety was assessed throughout the study periods. Efficacy was defined as having no treatment failures during the given time and was evaluated at 48 hours, 5 days, and 10 days postoperatively. Treatment was considered ineffective in patients who received more than 2 additional doses of rFVIIa beyond the protocol-defined doses during a 24 hour period. Patients who received alternative hemostatic therapy following the permitted two additional doses of rFVIIa were considered treatment failures. Results: Twenty-four patients (12 CI arm, 12 BI arm) underwent 9 major types of surgeries. Knee (n=11) and hip (n=3) replacements were the most common surgeries. Recombinant FVIIa efficacy in major surgeries was 92% (11 CI, 11 BI) at 48 hours; 83% (10 CI) and 92% (11 BI) at Day 5; 83% (10 CI) and 75% (9 BI) at Day 10. Sixty-six rescue doses (rFVIIa, 90 μg/kg) were administered in the CI group (54 in one patient), and 7 in 3 patients in the BI group. Adverse events occurred more frequently in the CI treatment group (239; 141 in one patient) compared to the BI group (89 AEs); 64 AEs occurred in the control group. Eight patients (3 CI, 4 BI, 1 control) experienced 10 serious adverse events (SAEs). SAEs occurred most frequently in the BI treatment group (3 CI, 6 BI, 1 control). The types of SAEs were equally distributed among the three groups. There were no serious thromboembolic events reported during the study. Conclusions: This summary of 24 major surgeries indicates that rFVIIa is effective as prophylactic therapy for major surgery in hemophilia A or B patients with inhibitors. The numbers of patients were too small to distinguish efficacy rates between the two groups. The safety profile for patients treated with rFVIIa (BI or CI) was similar to the profile for non-inhibitor patients treated with other factors. Presented on behalf of the NovoSeven in Surgery Study Investigators.

Haemostatic efficacy and safety of bolus and continuous infusion of recombinant factor VIIa are comparable in haemophilia patients with inhibitors undergoing major surgery

2007 ◽  
Vol 98 (10) ◽  
pp. 726-732 ◽  
Author(s):  
Prasad Mathew ◽  
Leonard Valentino ◽  
Michael Sumner ◽  
Stephanie Seremetis ◽  
Keith Hoots ◽  
...  
Keyword(s):  
Continuous Infusion ◽  
Surgical Management ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Orthopedic Procedures ◽  
Major Surgery ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label ◽  
Serious Adverse Events

SummaryBolus infusion (BI) recombinant factor VIIa (rFVIIa) administration is safe and effective in the surgical management of haemophilia patients with inhibitors but has not been compared directly with continuous infusion (CI). We conducted an open-label, randomized, multicenter trial comparing the efficacy and safety of rFVIIa administered by BI or CI for the surgical management of haemophilia A or B patients with inhibitors to FVIII or FIX. Safety was compared with that of a control group of noninhibitor patients receiving FVIII or FIX concentrates for major surgery. All inhibitor subjects received an initial bolus dose of 90 μg/kg rFVIIa and were then randomly assigned to BI (n=12) or CI (n=12). The BI group received 90 μg/kg rFVIIa every two hours (h) during surgery through day 5, then every four hours for days 6–10. The CI group received 50 μg/kg/h rFVIIa through day 5, then 25 mg/kg/h for days 6–10. The control group (n=12) received FVIII or FIX per institutional protocols. Twenty-two major surgeries included orthopedic procedures on the knee (n=13), hip (n=3), and abdominal/pelvis procedures (n=4). One patient with an autoimmune FVIII inhibitor randomized to the BI arm was excluded from efficacy analysis. Haemostatic efficacy of rFVIIa in each group was comparable: effective in 8/11 and 9/12 subjects in the BI and CI arms, respectively, and ineffective in three subjects in each arm. Serious adverse events were related to continued or increased bleeding. In conclusion, haemostatic efficacy and safety of BI and CI of rFVIIa are comparable for the surgical management of haemophilia subjects with inhibitors.

A Moxifloxacin-based Regimen for the Treatment of Recurrent, Drug-sensitive Pulmonary Tuberculosis: An Open-label, Randomized, Controlled Trial

2019 ◽  
Vol 70 (1) ◽  
pp. 90-98 ◽  
Author(s):  
Rubeshan Perumal ◽  
Nesri Padayatchi ◽  
Nonhlanhla Yende-Zuma ◽  
Anushka Naidoo ◽  
Dhineshree Govender ◽  
...  
Keyword(s):  
Adverse Events ◽  
Absolute Risk ◽  
Controlled Trial ◽  
Treatment Success ◽  
Control Group ◽  
Open Label ◽  
Serious Adverse Events ◽  
Conversion Rates ◽  
Significant Difference ◽  
Culture Conversion

Abstract Background The substitution of moxifloxacin for ethambutol produced promising results for improved tuberculosis treatment outcomes. Methods We conducted an open-label, randomized trial to test whether a moxifloxacin-containing treatment regimen was superior to the standard regimen for the treatment of recurrent tuberculosis. The primary and secondary outcomes were the sputum culture conversion rate at the end of 8 weeks and the proportion of participants with a favorable outcome, respectively. Results We enrolled 196 participants; 69.9% were male and 70.4% were co-infected with human immunodeficiency virus (HIV). There was no significant difference between the study groups in the proportion of patients achieving culture conversion at the end of 8 weeks (83.0% [moxifloxacin] vs 78.5% [control]; P = .463); however, the median time to culture conversion was significantly shorter (6.0 weeks, interquartile range [IQR] 4.0–8.3) in the moxifloxacin group than the control group (7.9 weeks, IQR 4.0– 11.4; P = .018). A favorable end-of-treatment outcome was reported in 86 participants (87.8%) in the moxifloxacin group and 93 participants (94.9%) in the control group, for an adjusted absolute risk difference of −5.5 (95% confidence interval −13.8 to 2.8; P = .193) percentage points. There were significantly higher proportions of participants with Grade 3 or 4 adverse events (43.9% [43/98] vs 25.5% [25/98]; P = .01) and serious adverse events (27.6% [27/98] vs 12.2% [12/98]; P = .012) in the moxifloxacin group. Conclusions The replacement of ethambutol with moxifloxacin did not significantly improve either culture conversion rates at the end of 8 weeks or treatment success, and was associated with a higher incidence of adverse events. Clinical Trials Registration NCT02114684.

Phase III, randomized, open-label study of triweekly docetaxel versus biweekly docetaxel as treatments for advanced hormone-refractory prostate cancer: Findings from an interim safety analysis of the Finnish Uro-oncological Group Study 1-2003.

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 129-129
Author(s):  
P. Hervonen ◽  
H. Joensuu ◽  
T. K. Joensuu ◽  
P. Nyandoto ◽  
M. Luukkaa ◽  
...  
Keyword(s):  
Adverse Events ◽  
Performance Status ◽  
Safety Analysis ◽  
Similar Efficacy ◽  
Multicenter Trial ◽  
Phase Iii ◽  
Open Label ◽  
Serious Adverse Events ◽  
Hormone Refractory ◽  
Grade 3

129 Background: Docetaxel (T) administered at every three weeks is standard treatment for advanced HRPC. We compared 2-weekly to 3-weekly T as first- or second-line chemotherapy of advanced HRPC in this prospective randomized multicenter trial. Methods: 360 pts were randomly allocated to receive T 75 mg/m2 i.v. d1 q3 wks (tT) or 50 mg/m2 i.v. d1 and d 14, q4 wks (bT) from March 2004 to May 2009. Prednisolon 10 mg/day was administered in both groups. The groups were well balanced according to the WHO performance status, mean age (70 vs. 68, range 45–87), and the median serum PSA level at study entry (109 vs. 98 μ g/L, range 11–1,490). The primary endpoint was TTF. Study identifier: NCT00255606 . Results: 158 pts (tT, 79; bT, 79) were included in this preplanned interim safety analysis. 567 and 487 cycles were administered in the tT and bT groups, respectively. The most common grade 3–4 adverse events (expressed as %/cycles) in tT /bT were neutropenia 20%/14%, infection with/without neutropenia 8%/3%, fatigue 3%/ 3%, febrile neutropenia 2%/1%, and bone pain 2%/1%. Serious adverse events occurred more frequently in tT (n=60, 10.6% of cycles) than in bT (n=29, 6.0%, p=0.012). One pt. died from coronary infarction and one was diagnosed with ALL (both in bT group). 30 pts (38%) in bT group and 22 pts (28%) in tT group were receiving treatment at 6 months. (p=0.176). Conclusions: Biweekly T has been better tolerated than the conventional triweekly T with fewer serious adverse events and may be associated with similar efficacy. [Table: see text]

Safety and Efficacy of Alteplase for Restoring Function in Occluded Central Venous Catheters: Results of the Cardiovascular Thrombolytic to Open Occluded Lines Trial

2002 ◽  
Vol 20 (1) ◽  
pp. 317-324 ◽  
Author(s):  
Steven R. Deitcher ◽  
Mark R. Fesen ◽  
Paul M. Kiproff ◽  
Patricia A. Hill ◽  
Xin Li ◽  
...  
Keyword(s):  
Adverse Events ◽  
Multicenter Trial ◽  
Central Venous Catheters ◽  
Phase Iii ◽  
Central Venous ◽  
Open Label ◽  
Serious Adverse Events ◽  
Safety And Efficacy ◽  
End Point ◽  
Bleeding Episodes

PURPOSE: To evaluate the safety and efficacy of alteplase (TPA) for restoring function to occluded central venous catheters (CVCs). PATIENTS AND METHODS: The study design was a phase III, open-label, single-arm multicenter trial. Subjects with occluded, nondialysis CVCs were enrolled. All subjects received a 2-mg dose of TPA within the dysfunctional catheter lumen that was allowed to dwell for 30 to 120 minutes. Functionality was tested at 30 and 120 minutes. If the CVC remained obstructed at 120 minutes, a second 2-mg TPA dose was allowed to dwell for 30 to 120 minutes. The primary safety end point was the rate of intracranial hemorrhage (ICH) within 5 days of treatment, and serious adverse events were recorded up to 30 days. RESULTS: Nine hundred ninety-five patients received treatment (female, 562; male, 433; mean age, 50.7 years; range, 2 to 91 years). CVCs treated were as follows: single (26%), double (39%), or triple (6%) lumen catheters or ports (29%). The primary end point was 0% ICH within 5 days. There were no cases of death, major bleeding episodes, or embolic events attributable to treatment. Flow was successfully restored in 52% and 78% of CVCs at 30 and 120 minutes after one dose, and 84% and 87% at 30 and 120 minutes after a second dose, respectively. Restoration of flow was 86%, 93%, 90%, and 79%, for single, double, and triple lumen catheters and ports, respectively. Estimated 30-day catheter patency was 74%. CONCLUSION: A regimen of up to two 2-mg doses of TPA is safe and effective for the restoration of flow to occluded central venous catheters.

EXPRESS: Altering the rehabilitation environment to improve stroke survivor activity (AREISSA): a Phase II trial.

2021 ◽  
pp. 174749302110069
Author(s):  
Heidi Janssen ◽  
Louise Ada ◽  
Sandy Middleton ◽  
Michael Pollack ◽  
Michael Nilsson ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Outcomes ◽  
Environmental Enrichment ◽  
Brain Plasticity ◽  
Social Activity ◽  
Stroke Survivor ◽  
Group Differences ◽  
Control Group ◽  
Serious Adverse Events ◽  
Clinical Trial Registration

Background: Environmental enrichment involves organisation of the environment and provision of equipment to facilitate engagement in physical, cognitive and social activity. In animals with stroke, it promotes brain plasticity and recovery. Aims: To assess the feasibility and safety of a patient-driven model of environmental enrichment incorporating access to communal and individual environmental enrichment. Methods: A non-randomised cluster trial with blinded measurement involving people with stroke (n=193) in 4 rehabilitation units was carried out. Feasibility was operationalised as activity 10 days after admission to rehabilitation and availability of environmental enrichment. Safety was measured as falls and serious adverse events. Benefit was measured as clinical outcomes at 3 months, by an assessor blinded to group. Results: The experimental group (n=91) spent 7% (95% CI -14 to 0) less time inactive, 9% (95% CI 0 to 19) more time physically, and 6% (95% CI 2 to 10) more time socially active than the control group (n=102). Communal environmental enrichment was available 100% of the time, but individual environmental enrichment was rarely within reach (24%) or sight (39%). There were no between-group differences in serious adverse events or falls at discharge or 3 months nor in clinical outcomes at 3 months. Conclusions: This patient-driven model of environmental enrichment was feasible and safe. However, the very modest increase in activity by people with stroke, and the lack of benefit in clinical outcomes 3 months after stroke do not provide justification for an efficacy trial. Clinical Trial Registration: ANZCTR 12613000796785 Words: 245

scholarly journals Comparison of Safety and Tolerability of Deutetrabenazine During Titration and Maintenance in Patients with Tardive Dyskinesia

CNS Spectrums ◽  
2021 ◽  
Vol 26 (2) ◽  
pp. 164-180
Author(s):  
Amanda Wilhelm ◽  
Karen E. Anderson ◽  
Hubert H. Fernandez ◽  
Hadas Barkay ◽  
Nayla Chaijale ◽  
...  
Keyword(s):  
Suicidal Ideation ◽  
Adverse Events ◽  
Tardive Dyskinesia ◽  
Dry Mouth ◽  
Fixed Dose ◽  
Open Label ◽  
Serious Adverse Events ◽  
Open Label Extension ◽  
Pharmaceutical Industries ◽  
Flexible Dose

AbstractBackgroundDeutetrabenazine is approved to treat tardive dyskinesia (TD) in adults and is titrated weekly by 6 mg/day, from 12 to 48 mg/day, based on dyskinesia control and tolerability. This analysis compared the safety of deutetrabenazine during titration versus maintenance.MethodsSafety was assessed during titration versus maintenance using integrated data from two 12-week placebo-controlled studies (ARM-TD and AIM-TD) and the open-label extension study. Rates were compared for overall and serious adverse events (AEs), AEs leading to discontinuation, treatment-related AEs, common AEs (≥4%), and specific AEs (parkinsonism, suicidal ideation, akathisia, restlessness).ResultsIn titration versus maintenance, AE rates with placebo (n=130) were: overall, 43.1% vs 25.4%; serious, 4.6% vs 2.3%; leading to discontinuation, 3.1% vs 0; treatment-related, 26.9% vs 10.0%. For placebo, common AEs during titration were somnolence, headache, nausea, fatigue, and dry mouth; none occurred during maintenance. In titration versus maintenance, AE rates in fixed-dose deutetrabenazine 12–36 mg (n=216) were: overall, 33.3–38.9% vs 22.2–29.2%; serious, 2.8–6.9% vs 0–1.4%; leading to discontinuation, 2.8–5.6% vs 0; treatment-related, 8.3–16.7% vs 8.3–13.9%. For fixed-dose deutetrabenazine, common AEs during titration were headache, diarrhea, nasopharyngitis, depression, hypertension, and dry mouth; headache was the only common AE during maintenance. In titration versus maintenance, AE rates with flexible-dose deutetrabenazine (n=168) were: overall, 49.4% vs 32.7%; serious, 3.6% vs 2.4%; leading to discontinuation, 2.4% vs 0.6%. For flexible-dose deutetrabenazine, the only common AE during titration was somnolence; none occurred during maintenance. Rates of parkinsonism, suicidal ideation, akathisia, and restlessness were low and comparable in titration and maintenance.ConclusionsDeutetrabenazine was well-tolerated, with AE rates similar to placebo during both phases; AE rates were higher during titration and decreased during maintenance.FundingTeva Pharmaceutical Industries Ltd., Petach Tikva, Israel

scholarly journals Open-Label Evaluation of Eteplirsen in Patients with Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping: PROMOVI Trial

2021 ◽  
pp. 1-13
Author(s):  
Craig M. McDonald ◽  
Perry B. Shieh ◽  
Hoda Z. Abdel-Hamid ◽  
Anne M. Connolly ◽  
Emma Ciafaloni ◽  
...  
Keyword(s):  
Duchenne Muscular Dystrophy ◽  
Muscular Dystrophy ◽  
Natural History ◽  
Adverse Events ◽  
Exon Skipping ◽  
Control Group ◽  
Phase 2 ◽  
Open Label ◽  
M Phase ◽  
Positive Treatment

Background Eteplirsen received accelerated FDA approval for treatment of Duchenne muscular dystrophy (DMD) with mutations amenable to exon 51 skipping, based on demonstrated dystrophin production. Objective To report results from PROMOVI, a phase 3, multicenter, open-label study evaluating efficacy and safety of eteplirsen in a larger cohort. Methods Ambulatory patients aged 7–16 years, with confirmed mutations amenable to exon 51 skipping, received eteplirsen 30 mg/kg/week intravenously for 96 weeks. An untreated cohort with DMD not amenable to exon 51 skipping was also enrolled. Results 78/79 eteplirsen-treated patients completed 96 weeks of treatment. 15/30 untreated patients completed the study; this cohort was considered an inappropriate control group because of genotype-driven differences in clinical trajectory. At Week 96, eteplirsen-treated patients showed increased exon skipping (18.7-fold) and dystrophin protein (7-fold) versus baseline. Post-hoc comparisons with patients from eteplirsen phase 2 studies (4658-201/202) and mutation-matched external natural history controls confirmed previous results, suggesting clinically notable attenuation of decline on the 6-minute walk test over 96 weeks (PROMOVI: –68.9 m; phase 2 studies: –67.3 m; external controls: –133.8 m) and significant attenuation of percent predicted forced vital capacity annual decline (PROMOVI: –3.3%, phase 2 studies: –2.2%, external controls: –6.0%; p <  0.001). Adverse events were generally mild to moderate and unrelated to eteplirsen. Most frequent treatment-related adverse events were headache and vomiting; none led to treatment discontinuation. Conclusions This large, multicenter study contributes to the growing body of evidence for eteplirsen, confirming a positive treatment effect, favorable safety profile, and slowing of disease progression versus natural history.

Allopurinol dose escalation to achieve serum urate below 6 mg/dL: an open-label extension study

2017 ◽  
Vol 76 (12) ◽  
pp. 2065-2070 ◽  
Author(s):  
Lisa K Stamp ◽  
Peter T Chapman ◽  
Murray Barclay ◽  
Anne Horne ◽  
Christopher Frampton ◽  
...  
Keyword(s):  
Adverse Events ◽  
Dose Escalation ◽  
Controlled Trial ◽  
Serum Urate ◽  
Extension Study ◽  
Open Label ◽  
Serious Adverse Events ◽  
Open Label Extension ◽  
Randomised Controlled ◽  
Kidney Impairment

ObjectivesTo determine the long-term safety and efficacy of allopurinol dose escalation (DE) to achieve target serum urate (SU) in gout.MethodsPeople, including those with chronic kidney disease, who completed the first 12 months of a randomised controlled trial continued into a 12-month extension study. Participants randomised to continue current dose for the first 12 months began allopurinol DE at month 12 if SU was ≥6 mg/dL (control/DE). Immediate DE participants who achieved target SU maintained allopurinol dose (DE/DE). The primary endpoints were reduction in SU and adverse events (AEs) at month 24.ResultsThe mean (SE) change in SU from month 12 to 24 was −1.1 (0.2) mg/dL in control/DE and 0.1 (0.2) mg/dL in DE/DE group (p<0.001). There was a significant reduction in the percentage of individuals having a gout flare in the month prior to months 12 and 24 compared with baseline in both groups and in mean tophus size over 24 months, but no difference between randomised groups. There were similar numbers of AEs and serious adverse events between groups.ConclusionsThe majority of people with gout tolerate higher than creatinine clearance-based allopurinol dose and achieve and maintain target SU. Slow allopurinol DE may be appropriate in clinical practice even in those with kidney impairment.Trial registration numberACTRN12611000845932

scholarly journals Nervous and Muscular Adverse Events after COVID-19 Vaccination: A Systematic Review and Meta-Analysis of Clinical Trials

Vaccines ◽  
2021 ◽  
Vol 9 (8) ◽  
pp. 939
Author(s):  
Jiaxin Chen ◽  
Yuangui Cai ◽  
Yicong Chen ◽  
Anthony P. Williams ◽  
Yifang Gao ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Events ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Phase 1 ◽  
Cochrane Library ◽  
Categorical Variables ◽  
Control Group ◽  
Open Label

Background: Nervous and muscular adverse events (NMAEs) have garnered considerable attention after the vaccination against coronavirus disease (COVID-19). However, the incidences of NMAEs remain unclear. We aimed to calculate the pooled event rate of NMAEs after COVID-19 vaccination. Methods: A systematic review and meta-analysis of clinical trials on the incidences of NMAEs after COVID-19 vaccination was conducted. The PubMed, Medline, Embase, Cochrane Library, and Chinese National Knowledge Infrastructure databases were searched from inception to 2 June 2021. Two independent reviewers selected the study and extracted the data. Categorical variables were analyzed using Pearson’s chi-square test. The pooled odds ratio (OR) with the corresponding 95% confidence intervals (CIs) were estimated and generated with random or fixed effects models. The protocol of the present study was registered on PROSPERO (CRD42021240450). Results: In 15 phase 1/2 trials, NMAEs occurred in 29.2% vs. 21.6% (p < 0.001) vaccinated participants and controls. Headache and myalgia accounted for 98.2% and 97.7%, and their incidences were 16.4% vs. 13.9% (OR = 1.97, 95% CI = 1.28–3.06, p = 0.002) and 16.0% vs. 7.9% (OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) in the vaccine and control groups, respectively. Headache and myalgia were more frequent in the newly licensed vaccines (OR = 1.97, 95% CI = 1.28–3.06, p = 0.02 and OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) and younger adults (OR = 1.40, 95% CI = 1.12–1.75, p = 0.003 and OR = 1.54, 95% CI = 1.20–1.96, p < 0.001). In four open-label trials, the incidences of headache, myalgia, and unsolicited NMAEs were 38.7%, 27.4%, and 1.5%. Following vaccination in phase 3 trials, headache and myalgia were still common with a rate of 29.5% and 19.2%, although the unsolicited NMAEs with incidence rates of ≤ 0.7% were not different from the control group in each study. Conclusions: Following the vaccination, NMAEs are common of which headache and myalgia comprised a considerable measure, although life-threatening unsolicited events are rare. NMAEs should be continuously monitored during the ongoing global COVID-19 vaccination program.

scholarly journals Efficacy and Safety of Lianhuaqingwen Capsules for the Prevention of Coronavirus Disease 2019: A Prospective Open-Label Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Xiaowei Gong ◽  
Boyun Yuan ◽  
Yadong Yuan ◽  
Fengju Li
Keyword(s):  
Nucleic Acid ◽  
Treatment Group ◽  
Close Contact ◽  
Controlled Trial ◽  
Control Group ◽  
Open Label ◽  
Medical Observation ◽  
Observation Period ◽  
Close Contacts ◽  
Nucleic Acid Tests

Coronavirus disease 2019 (COVID-19) has become a global pandemic. Community and close contact exposures continue to drive the COVID-19 pandemic. There is no confirmed effective treatment for suspected cases and close contacts. Lianhuaqingwen (LH) capsules, a repurposed Chinese herbal product that is currently on the market, have proven effective for influenza and COVID-19. To determine the safety and efficacy of LH capsules for the prevention of COVID-19, we conducted a prospective open-label controlled trial of LH capsules on subjects who had close contact with people infected with COVID-19. Subjects received LH capsules (4 capsules, three times daily) or the usual medical observation for 14 days. The primary endpoint was the rate of positive nucleic acid tests of nasal and pharyngeal swabs during the quarantine medical observation period. We included 1976 patients, including 1101 in the treatment group and 875 in the control group. The rate of positive nucleic acid tests in the treatment group was significantly lower than that in the control group (0.27% vs. 1.14%, respectively; mean difference: −0.87%; 95% CI: −1.83 to −0.13; p = 0.0174 ) during the quarantine medical observation period (14 days). Among subjects with different close contact states, there was no significant difference in the rate of positive nucleic acid test results among close contacts in the treatment group and the control group (6.45% vs. 11.43%, respectively; p = 0.6762 ). Among secondary close contacts, the rate of positive nucleic acid tests in the treatment group was significantly lower than that in the control group (0.09% vs. 0.71%, respectively; p = 0.0485 ). No serious adverse events were reported. Taken together, and in light of the safety and effectiveness profiles, these results show that LH capsules can be considered to prevent the progression of COVID-19 after close contact with an infected person. This trial is registered with ChiCTR2100043012.

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