Randomized, Double-Blinded, Phase 2 Trial of WR 279,396 (Paromomycin and Gentamicin) for Cutaneous Leishmaniasis in Panama

Abstract Background Curcumin, a derivative of the spice turmeric, has been adopted by Eastern medicine for centuries as an adjunct to treat several medical conditions (e.g., anorexia and arthritis) because of its well-established anti-inflammatory properties. Studies have shown that the use of curcumin in mice models has led to reduction in several inflammatory markers as well as key inflammatory pathway enzymes. As a result, studies in Western medicine have developed to determine if this recognized benefit can be utilized for patients with inflammatory lung diseases, such as asthma. This study will seek to better understand if curcumin can be used as an adjunctive therapy for improving asthma control of patients with moderate to severe asthma; a finding we hope will allow for a more affordable treatment. Methods This study will utilize a randomized, placebo controlled, double blinded pilot superiority phase 2 trial at an outpatient pulmonary clinic in Southern California, USA. Subjects will be receiving Curcumin 1500 mg or matching placebo by mouth twice daily for the study period of 12 weeks. Subjects will be randomized to either a placebo or intervention Curcumin. Subjects will have 6 clinic visits: screening visit, a baseline visit, monthly clinic visits (weeks 4, 8, and 12), at weeks 4, 8, and a follow-up clinic visit or phone-call (week 16). Changes in asthma control test scores, number of days missed from school/work, FEV1 (% predicted), FEV1/FVC ratio, FVC (% predicted), blood eosinophil count, blood total IgE, and FeNO levels will be compared by group over time. Discussion The therapeutic effects of curcumin have been studied on a limited basis in asthmatics and has shown mixed results thus far. Our study hopes to further establish the benefits of curcumin, however, there are potential issues that may arise from our study design that we will address within this paper. Moreover, the onset of the COVID-19 pandemic has resulted in safety concerns that have delayed initiation of our study. This study will contribute to existing literature on curcumin’s role in reducing lung inflammation as it presents in asthmatics as well as patients suffering from COVID-19. Trial registration This study protocol has been approved by the Institutional Review Board at Loma Linda University Health, (NCT04353310). IND# 145101 Registered April 20th, 2020. https://clinicaltrials.gov/ct2/show/NCT04353310.

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Exploratory analysis based on tumor location of REACHIN, a randomized, double-blinded, placebo-controlled phase 2 trial of regorafenib after failure of gemcitabine and platinum-based chemotherapy for advanced/metastatic biliary tract tumors

Annals of Oncology ◽

10.1093/annonc/mdz154.002 ◽

2019 ◽

Vol 30 ◽

pp. iv127 ◽

Cited By ~ 1

Author(s):

A. Demols ◽

I. Borbath ◽

M. Van den Eynde ◽

G. Houbiers ◽

M. Peeters ◽

...

Keyword(s):

Biliary Tract ◽

Tumor Location ◽

Exploratory Analysis ◽

Phase 2 ◽

Phase 2 Trial ◽

Platinum Based Chemotherapy ◽

Biliary Tract Tumors ◽

Double Blinded

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P.130 Bumetanide versus placebo for core symptoms of autism spectrum disorder at 91 days (BAMBI): a single-centre, double-blinded, patient-randomized, placebo-controlled, phase-2-trial

European Neuropsychopharmacology ◽

10.1016/j.euroneuro.2020.09.108 ◽

2020 ◽

Vol 40 ◽

pp. S80-S81

Author(s):

J. Sprengers ◽

D. Van Andel ◽

N. Zuithoff ◽

M. Keijzer-Veen ◽

S. Annelien ◽

...

Keyword(s):

Autism Spectrum Disorder ◽

Autism Spectrum ◽

Spectrum Disorder ◽

Phase 2 ◽

Single Centre ◽

Phase 2 Trial ◽

Double Blinded ◽

Core Symptoms

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Extended Safety, Immunogenicity and Efficacy of a Blood-Stage Malaria Vaccine in Malian Children: 24-Month Follow-Up of a Randomized, Double-Blinded Phase 2 Trial

PLoS ONE ◽

10.1371/journal.pone.0079323 ◽

2013 ◽

Vol 8 (11) ◽

pp. e79323 ◽

Cited By ~ 30

Author(s):

Matthew B. Laurens ◽

Mahamadou A. Thera ◽

Drissa Coulibaly ◽

Amed Ouattara ◽

Abdoulaye K. Kone ◽

...

Keyword(s):

Malaria Vaccine ◽

Blood Stage ◽

Phase 2 ◽

Phase 2 Trial ◽

Double Blinded ◽

Blood Stage Malaria

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Immunogenicity and safety of HBAI20 Hepatitis B vaccine in non‐responders: double‐blinded, randomised, controlled phase 2 trial

Liver International ◽

10.1111/liv.14939 ◽

2021 ◽

Author(s):

Özgür Muhammet Koc ◽

Philippe De Smedt ◽

Cécile Kremer ◽

Geert Robaeys ◽

Pierre Van Damme ◽

...

Keyword(s):

Hepatitis B ◽

Hepatitis B Vaccine ◽

Phase 2 ◽

Phase 2 Trial ◽

Randomised Controlled ◽

Double Blinded

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Dose-adjusted enoxaparin thromboprophylaxis in hospitalized cancer patients: a randomized, double-blinded multicenter phase 2 trial

Blood Advances ◽

10.1182/bloodadvances.2020001804 ◽

2020 ◽

Vol 4 (10) ◽

pp. 2254-2260

Author(s):

Jeffrey I. Zwicker ◽

Joanna Roopkumar ◽

Maneka Puligandla ◽

Benjamin L. Schlechter ◽

Anish V. Sharda ◽

...

Keyword(s):

High Risk ◽

Hospitalized Patients ◽

Fixed Dose ◽

Phase 2 ◽

Patients With Cancer ◽

Phase 2 Trial ◽

Increased Risk ◽

High Incidence ◽

Pharmacologic Thromboprophylaxis ◽

Double Blinded

Abstract Hospitalized patients with cancer are at an increased risk of developing venous thromboembolism (VTE). The recommendation for routine pharmacologic thromboprophylaxis in hospitalized patients with cancer to prevent VTE is based on extrapolation of results from noncancer cohorts. There are limited data to support the efficacy and safety of fixed-dose low-molecular-weight heparin (LMWH) regimens in high-risk hospitalized patients with cancer. We conducted a randomized, double-blinded, phase 2 trial in hospitalized patients with active cancer at high risk of developing VTE based on Padua risk score. Patients were randomly assigned to fixed-dose enoxaparin (40 mg daily) vs weight-adjusted enoxaparin (1 mg/kg daily) during hospitalization. The primary objectives were to evaluate the safety of dose-adjusted enoxaparin and evaluate the incidence of VTE with fixed-dose enoxaparin. Blinded clinical assessments were performed at day 14, and patients randomly assigned to fixed-dose enoxaparin subsequently underwent a bilateral lower extremity ultrasound. A total of 50 patients were enrolled and randomized. The median weight of patients enrolled in weight-adjusted enoxaparin arm was 76 kg (range, 60.9-124.5 kg). There were no major hemorrhages or symptomatic VTE in either arm. At time of completion of the blinded clinical assessment, there was only 1 incidentally identified pulmonary embolus that occurred in the weight-adjusted arm. In the group randomly assigned to fixed-dose enoxaparin who subsequently underwent surveillance ultrasound, the cumulative incidence of DVT was 22% (90% binomial confidence interval, 0%-51.3%). This phase 2 trial confirms a high incidence of asymptomatic VTE among high-risk hospitalized patients with cancer and that weight-adjusted LMWH thromboprophylaxis is feasible and well-tolerated. This trial was registered at www.clinicaltrials.gov as #NCT02706249.

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Safety and Immunogenicity of CpG 1018 and Aluminium Hydroxide-Adjuvanted SARS-CoV-2 S-2P Protein Vaccine MVC-COV1901: A Large-Scale Double-Blinded, Randomised, Placebo-Controlled Phase 2 Trial

10.1101/2021.08.05.21261532 ◽

2021 ◽

Author(s):

Szu-Min Hsieh ◽

Ming-Che Liu ◽

Yen-Hsu Chen ◽

Wen-Sen Lee ◽

Shinn-Jang Hwang ◽

...

Keyword(s):

Adverse Events ◽

Aluminium Hydroxide ◽

Large Scale ◽

Geometric Mean ◽

Phase 2 ◽

Protein Vaccine ◽

Multi Centre Study ◽

Phase 2 Trial ◽

Double Blinded ◽

Study Participants

Background We have assessed the safety and immunogenicity of MVC-COV1901, a recombinant protein vaccine containing prefusion-stabilized spike protein S-2P adjuvanted with CpG 1018 and aluminium hydroxide against COVID-19. Methods This is a phase 2, prospective, double-blinded, placebo-controlled, and multi-centre study to evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 vaccine candidate MVC-COV1901. The study comprised 3,844 participants of ≥ 20 years who were generally healthy or with stable pre-existing medical conditions. The study participants were randomly assigned in a 6:1 ratio to receive either MVC-COV1901 containing 15 mcg of S-2P protein or placebo containing saline. Participants received two doses of MVC-COV1901 or placebo, administered 28 days apart via intramuscular injection. The primary outcomes were to evaluate the safety, tolerability, and immunogenicity of MVC-COV1901 from Day 1 (the day of first vaccination) to Day 57 (28 days after the second dose). Immunogenicity of MVC-COV1901 was assessed through geometric mean titres (GMT) and seroconversion rates (SCR) of neutralising antibody and antigen-specific immunoglobulin. This clinical trial is registered at ClinicalTrials.gov: NCT04695652. Findings From the start of this phase 2 trial to the time of interim analysis, no vaccine-related Serious Adverse Events (SAEs) was recorded. The most common solicited adverse events across all study participants were pain at the injection site (64%), and malaise/fatigue (35%). Fever was rarely reported (<1%). For all participants in the MVC-COV1901 group, at 28 days after the second dose against wild type SARS-CoV-2 virus, the GMT was 662.3 (408 IU/mL), the GMT ratio was 163.2, and the seroconversion rate was 99.8%. Interpretation MVC-COV1901 shows good safety profiles and promising immunogenicity responses. The current data supports MVC-COV1901 to enter phase 3 efficacy trials, and could enable regulatory considerations for Emergency Use Authorisation (EUA). Funding Medigen Vaccine Biologics Corporation and Taiwan Centres for Disease Control.

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