scholarly journals Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability edema in patients with moderate-to-severe ARDS - a randomized, placebo-controlled, double-blind trial

2021 ◽  
Author(s):  
Benedikt Schmid ◽  
Markus Kredel ◽  
Roman Ullrich ◽  
Katharina Krenn ◽  
Rudolf Lucas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Distress Syndrome ◽  
Data Safety Monitoring Board ◽  
Investigational Drug ◽  
Double Blind ◽  
Healthy Humans ◽  
Pulmonary Permeability ◽  
The Eu

Abstract Background Acute respiratory distress syndrome (ARDS) is a complex clinical diagnosis with various possible etiologies. One common feature, however, is pulmonary permeability edema, which leads to an increased alveolar diffusion pathway and, subsequently, impaired oxygenation and decarboxylation. A novel inhaled peptide agent (AP301, solnatide) was shown to markedly reduce pulmonary edema in animal models of ARDS and to be safe to administer to healthy humans in a phase-I clinical trial. Here, we present the protocol for a phase-IIB clinical trial investigating the safety and possible future efficacy endpoints in ARDS patients.Methods This is a randomized, placebo-controlled, double-blind intervention study. Patients with moderate to severe ARDS in need of mechanical ventilation will be randomized to parallel groups receiving escalating doses of solnatide or placebo, respectively. Before advancing to a higher dose, a data safety monitoring board will investigate the data from previous patients for any indication of patient safety violations. The intervention (application of the investigational drug) takes places twice daily over the course of seven days, ensued by a follow-up period of another 21 days.Discussion The patients to be included in this trial will be severely sick and in need of mechanical ventilation. The amount of data to be collected upon screening and during the course of the intervention phase is substantial and the potential timeframe for inclusion of any given patient is short. However, when prepared properly, adherence to this protocol will make for the acquisition of reliable data. Particular diligence needs to be exercised with respect to informed consent, because eligible patients will most likely be comatose and/or deeply sedated at the time of inclusion.Trial registration: This trial was prospectively registered with the EU Clinical trials register (clinicaltrialsregister.eu). EudraCT Number: 2017-003855-47.

scholarly journals Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability edema in patients with moderate-to-severe ARDS—a randomized, placebo-controlled, double-blind trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Benedikt Schmid ◽  
Markus Kredel ◽  
Roman Ullrich ◽  
Katharina Krenn ◽  
Rudolf Lucas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Distress Syndrome ◽  
Data Safety Monitoring Board ◽  
Investigational Drug ◽  
Double Blind ◽  
Healthy Humans ◽  
Pulmonary Permeability ◽  
The Eu

Abstract Background Acute respiratory distress syndrome (ARDS) is a complex clinical diagnosis with various possible etiologies. One common feature, however, is pulmonary permeability edema, which leads to an increased alveolar diffusion pathway and, subsequently, impaired oxygenation and decarboxylation. A novel inhaled peptide agent (AP301, solnatide) was shown to markedly reduce pulmonary edema in animal models of ARDS and to be safe to administer to healthy humans in a Phase I clinical trial. Here, we present the protocol for a Phase IIB clinical trial investigating the safety and possible future efficacy endpoints in ARDS patients. Methods This is a randomized, placebo-controlled, double-blind intervention study. Patients with moderate to severe ARDS in need of mechanical ventilation will be randomized to parallel groups receiving escalating doses of solnatide or placebo, respectively. Before advancing to a higher dose, a data safety monitoring board will investigate the data from previous patients for any indication of patient safety violations. The intervention (application of the investigational drug) takes places twice daily over the course of 7 days, ensued by a follow-up period of another 21 days. Discussion The patients to be included in this trial will be severely sick and in need of mechanical ventilation. The amount of data to be collected upon screening and during the course of the intervention phase is substantial and the potential timeframe for inclusion of any given patient is short. However, when prepared properly, adherence to this protocol will make for the acquisition of reliable data. Particular diligence needs to be exercised with respect to informed consent, because eligible patients will most likely be comatose and/or deeply sedated at the time of inclusion. Trial registration This trial was prospectively registered with the EU Clinical trials register (clinicaltrialsregister.eu). EudraCT Number: 2017-003855-47.

Viscosupplementation in patients with severe osteoarthritis of the knee: six month follow-up of a randomized, double-blind clinical trial

2017 ◽  
Vol 41 (11) ◽  
pp. 2273-2280 ◽  
Author(s):  
André Luiz Siqueira Campos ◽  
Rodrigo Satamini Pires e Albuquerque ◽  
Edmilson Barbosa da Silva ◽  
Sami Gobbi Fayad ◽  
Lucas Delunardo Acerbi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Osteoarthritis Of The Knee ◽  
Double Blind ◽  
Double Blind Clinical Trial

scholarly journals Six month follow-up of two Bulk-fill composites in non-carious cervical lesions: Double blind randomized clinical trial.

2020 ◽  
Vol 8 (3) ◽  
pp. 210-219
Author(s):  
Patricio Vildósola ◽  
◽  
Jorge Nakouzi ◽  
Sara Rodriguez ◽  
Alexandra Reyes ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Cervical Lesions ◽  
Double Blind

Effect of a Persian metabolic diet on the functional dyspepsia symptoms in patients with postprandial distress syndrome: a randomized, double-blind clinical trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Fereshteh Nouri ◽  
Mohsen Naseri ◽  
Saeed Abdi ◽  
Soghrat Faghihzadeh ◽  
Mehdi Pasalar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Distress Syndrome ◽  
P Value ◽  
Intervention Period ◽  
Dietary Regimen ◽  
Postprandial Distress Syndrome ◽  
Severity Scores ◽  
Significant Difference ◽  
Persian Medicine

Abstract Objectives Postprandial distress syndrome (PDS) is associated with food indigestion. Efficacy of drugs used against PDS is limited whereas dietary modifications were shown to have important beneficial effects. Traditional Persian Medicine (TPM) sages suggested a dietary regimen known as Persian metabolic diet (PMD) for the management of PDS patients. In this study, the efficacy of PMD in alleviating the symptoms of PDS was explored. Methods This single-center, parallel-group, randomized clinical trial included 56 patients whom were randomly allocated to PMD group (29 participants) and Optional diet (OD) group (27 participants). They were instructed to follow the protocol for two weeks. Using a standard validated questionnaire, all outcomes were evaluated at baseline, end of the intervention period, and end of follow-up time. Results At the end of the intervention period, comparing the changes of severity scores between the groups showed a statistically significant difference in week 2 (p-value<0.001) and week 8 (p-value<0.001) follow-up comparing to the baseline. Similarly, at the end of the follow-up period, epigastric fullness, epigastric discomfort, and bloating were significantly improved in the PMD group (p<0.001). Conclusions This diet prepared based on Persian medicine seems to be effective in relieving the symptoms of patients with PDS.

Effects of individually chosen homoeopathic medicines on recurrent URTI in children

1996 ◽  
Vol 85 (01) ◽  
pp. 4-14
Author(s):  
J. Blommers ◽  
D.J. Kuik ◽  
L. Feenstra ◽  
P.D. Bezemer ◽  
E.S.M. De Lange-De Klerk
Keyword(s):  
Clinical Trial ◽  
University Hospital ◽  
Controlled Clinical Trial ◽  
Upper Respiratory Tract ◽  
Eligibility Criteria ◽  
Double Blind ◽  
Upper Respiratory ◽  
The University ◽  
Current Standards

AbstractThe effects of homoeopathic medicines on children suffering from recurrent upper respiratory tract infection (URTI) were studied in a randomized double-blind placebo-controlled clinical trial conducted at the paediatric outpatients department of the university hospital of the Vrije Universiteit in Amsterdam from 1987 to 1992.The study was designed to meet both the requirements of proper homoeopathic practice and the current standards of a clinical trial. The purpose of a randomized placebo-controlled double-blind trial is to identify the effects of the agents under investigation by equalizing the effects of other factors that may influence outcome.The object of the trial, eligibility criteria, follow-up period, treatments and concurrent interventions, data collection and effect measures are discussed in the light of homoeopathic thinking.

scholarly journals Effect of polymerized type I collagen in hyperinflammation of adult outpatients with symptomatic COVID-19: a double blind, randomised, placebo-controlled clinical trial.

2021 ◽  
Author(s):  
Silvia Mendez-Flores ◽  
Angel Alexis Priego-Ranero ◽  
Daniel Azamar-Llamas ◽  
Hector Olvera-Prado ◽  
Kenia Illian Rivas-Redondo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Oxygen Saturation ◽  
Primary Outcome ◽  
Type I Collagen ◽  
Ambient Air ◽  
Controlled Clinical Trial ◽  
Type I ◽  
Double Blind ◽  
Duration Of Symptoms

BACKGROUND Currently, therapeutic options for ambulatory COVID-19 patients are limited. OBJECTIVE To evaluate the safety, efficacy and effect of the intramuscular administration of polymerized type I collagen (PTIC) on hyperinflammation, oxygen saturation and symptom improvement in adult outpatients with symptomatic COVID-19. DESIGN Double-blind, randomised, placebo-controlled clinical trial of PTIC vs placebo. SETTING Single Third-level hospital in Mexico City (Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran) PARTICIPANTS Eighty-nine adult participants with a confirmed COVID-19 diagnosis and symptom onset within the 7 days preceding recruitment were included from August 31, 2020 to November 7, 2020 and followed for 12 weeks. Final date of follow-up was February 4, 2021. INTERVENTIONS Patients were randomly assigned to receive either 1.5 ml of PTIC intramuscularly every 12 h for 3 days and then every 24 h for 4 days (n=45), or matching placebo (n=44). MAIN OUTCOMES AND MEASURES The primary outcome was a mean reduction of at least 50% in the level of IP-10 compared to baseline. The secondary outcomes were mean oxygen saturation >92% while breathing ambient air and duration of symptoms. RESULTS Of 89 patients who were randomised, 87 (97.8%) were included in an intention-to-treat analysis; 37 (41.6%) were male and mean age was 48.5+/-14.0 years. The IP-10 levels decreased 75% in the PTIC group and 40% in the placebo group vs baseline. The comparison between treatment vs placebo was also statistically significant (P=0.0047). The IL-8 (44%, P=0.045), M-CSF (25%, P=0.041) and IL-1Ra (36%, P=0.05) levels were also decreased in the PTIC group vs baseline. Mean oxygen saturation >92% was achieved by 40/44 (90%), 41/42 (98%) and 40/40 (100%) of participants that received PTIC at 8, 15 and 97 days of follow-up vs 29/43 (67%), 31/39 (80%) and 33/37 (89%) of patients treated with placebo (P=0.001). The unadjusted accelerated failure time model showed that patients treated with PTIC achieved the primary outcome 2.70-fold faster (P<0.0001) than placebo. In terms of risk, the group of patients treated with PTIC had a 63% lower risk of having a mean oxygen saturation <92% vs placebo (P<0.0001). Symptom duration in patients treated with PTIC was reduced by 6.1+/-3.2 days vs placebo. No differences in adverse effects were observed between the groups at 8, 15 and 97 days of follow-up. CONCLUSIONS In this study, treatment with PTIC down-regulated IP-10, IL-8, M-CSF and IL-Ra levels, which could explain the PTIC effect on the higher proportion of patients with mean oxygen saturation readings > 92% and a shorter duration of symptoms as compared to patients treated with placebo. Although results are encouraging, larger randomised trials are needed.

scholarly journals Randomized clinical trial to assess the protective efficacy of a Plasmodium vivax CS synthetic vaccine

2021 ◽  
Author(s):  
Socrates Herrera ◽  
Myriam Arevalo-Herrera ◽  
Michelle Larmart-Delgado ◽  
Maria Alejandra Caicedo ◽  
Juliana Henao-Geraldo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Plasmodium Vivax ◽  
Malaria Infection ◽  
Protective Efficacy ◽  
Protein A ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Cell Responses ◽  
Controlled Human Malaria Infection

Abstract A randomized, double-blind, controlled clinical trial was conducted to assess the safety and protective efficacy of the Plasmodium vivax circumsporozoite (CS) protein. A total of 35 healthy adults, either malaria-naïve (n=17) or P.vivax semi-immune (n=18), were enrolled and immunized intramuscularly (i.m.) at months 0, 2, and 6, with the PvCS (150 μg) formulated in Montanide ISA-51 adjuvant. Most volunteers developed PvCS specific antibody and T-cell responses and were subjected to a P. vivax sporozoite controlled human malaria infection (CHMI) 30 days after the last immunization. Sterile protection was observed in five of 11 naïve (42%) and four of 11 semi-immune (36%) volunteers by showing no parasitemia during the 60 days follow-up, as did a semi-immune control (1/5) volunteer. All non-protected volunteers developed malaria symptoms 10-19 days after CHMI and were immediately treated with antimalarial drugs. This is the first study of a P. vivax sub-unit vaccine demonstrating sterile protection against P. vivax infection.

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