Neoplasms

Symptoms and General Pathology

All Conditions

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Wounds and Injuries

Musculoskeletal Diseases

Neoplasm Metastasis

COVID-19

Fractures, Bone

Communicable Diseases

Coronavirus Infections

Bone Neoplasms

Coronaviridae Infections

Nidovirales Infections

Virus Diseases

RNA Virus Infections

Bone Diseases

Stefano Bonarelli, MD

Over the last months, the Rizzoli Orthopedic Institute in Bologna, Italy, has drained orthopedic urgencies from all other hospitals in the urban and suburban area. In this context urgencies are defined as fractures and primary or metastatic bone lesions with indication to non-deferrable surgery. A subset of these patients tested positive for SARS CoV 2, either before or after the surgical procedure.

Anesthesiological clinical management of covid19 cases is complicated by the consequences of the viral infection on respiratory and cardio-vascular systems, renal function and coagulation. Similarly, management of asymptomatic patients is challenging because of the lack of data on possible specific complications.

This study will report a snapshot of our early experience on perioperative clinical management of patients undergoing orthopedic surgery in the presence of SARS CoV 2 infection, ascertained or not at the time of surgery.

This is a monocentric, retrospective, observational study.

the study will analyze all medical records of patients that underwent major or non-delayable orthopaedic surgery from the 1st of March 2020 to the 30th of June 2020 with known ongoing Coronavirus infection or postoperative diagnosis via nasal swab test collected at Rizzoli Orthopaedic Institute.

Medical history, anthropometrical, clinical, radiological, and biochemical data will be inserted in a database.

Primary objective will be to estimate population mortality in the time frame from surgery to hospital discharge.

Secondary objectives will be estimation of correlation between SARS-CoV2 infection and main postoperative complications. Mortality and site infection rate will be compared among the cohort and pre-COVID19 similar data.

Continuous variables will be summarized using median and interquartile range while dichotomic variables will be expressed as absolute and relative frequencies. Frequencies and outcomes will be reported as absolute frequency (observed / total) and relative percentage. Association between independent variables and outcomes will be tested with multivariate analysis, hypothesis testing (t-test or Mann-Whitney) and Fisher's exact test according to the type of variable and its distribution (and the experimental question at hand). Variables showing statistically significant association (p\<0.1), will be used to build a multivariate logistic regression model with dichotomic dependent variable. Statistical significance threshold will be set to 0.05.

Retrospective Case Series of COVID19+ Patients Undergoing Orthopedic Surgery

Retrospective Evaluation of Patients With Coronavirus 19 Infection Undergoing Major Orthopedic Urgent Surgery: a Case Series

Publication or posting on trial registers

Overall mortality in patients with ascertained SARS-CoV-2 infection undergoing major orthopaedic surgery

Descriptive analysis of the characteristics of the population

Correlation between known SARS-CoV2 infection at the time of surgery and type of anesthesia

Correlation between known SARS-CoV2 infection at the time of surgery and mortality

Correlation between ascertained SARS-CoV2 infection and deep vein thrombosis/pulmonary embolism

Correlation between ascertained SARS-CoV2 infection and surgical site infection

Correlation between ascertained SARS-CoV2 infection and need for postoperative oxygen therapy / non-invasive or invasive ventilation

Correlation between ascertained SARS-CoV2 infection and thromboelastography indicies.

Comparison of mortality of patients with SARS-CoV2 infection with historical population data subjected to urgent orthopedic surgery.

Comparison of surgical site infection rate of patients with SARS-CoV2 infection with historical population data subjected to urgent orthopedic surgery.

Istituto Ortopedico Rizzoli

Pneumonia

Pneumonia, Viral

Respiratory Tract Infections

Lung Diseases

Respiratory Tract Diseases

Anti-Arrhythmia Agents

Antihypertensive Agents

All Drugs and Chemicals

Anti-Infective Agents

Vasoconstrictor Agents

Losartan

Ivermectin

Angiotensin II

Giapreza

Angiotensinogen

Angiotensin II Type 1 Receptor Blockers

Angiotensin Receptor Antagonists

Antiparasitic Agents

Patients will receive ivermectin-placebo single dose on the day of confirmed diagnosis of COVID-19, followed by losartan-placebo daily for 15 days.

Patients will receive a single dose of 12mg of ivermectin on the day of the confirmed diagnosis of COVID-19, followed by losartan 50mg orally once daily for 15 consecutive days

Use of the combination of ivermectin-placebo plus losartan-placebo as early treatment for COVID-19 in cancer patients

Placebo

Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients

Pedro Exman, MD

Maria del Pilar Diz, MD, PhD

Ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19

This is a randomized, doubled-blind and placebo-controlled phase II study that will evaluate the efficacy of the early use of ivermectin plus losartan in cancer patients who present with recent diagnosis of COVID-19.

The trial will enroll 176 patients with previous diagnosis of active cancer (88 in each arm) and the aim of the study is to assess the efficacy of these drugs combination to decrease the incidence of COVID-19 severe complications. Patients will receive single dose ivermectin of 12mg after the confirmed diagnosis of COVID-19, followed by 15 days of losartan.

We believe that the association of anti-viral activity of the ivermectin plus the extracellular blockade of the receptor used by the virus will decrease the overall viremia and subsequently improve clinical outcomes.

Early Treatment With Ivermectin and LosarTAN for Cancer Patients With COVID-19 Infection

Randomized, Doubled-blind Phase II Trial Evaluating the Use of Ivermectin Plus Losartan for Prophylaxis of Severe Events in Cancer Patients With Recent Diagnosis of COVID-19

no plan to share individual participant data

Incidence of severe complications due COVID-19 infection defined as need for ICU admission, need for mechanical ventilation, or death

Severe Acute Respiratory Syndrome defined as oxygen saturation less than 93%

Severe Acute Respiratory Syndrome defined as respiratory rate higher than 24 incursion per minute

Incidence of hepatic toxicity (elevation of ALT, AST above the upper limit of normal, measured by U/L)

Incidence of hepatic toxicity (elevation of bilirubin above the upper limit of normal, measured by mg/dL)

Incidence of renal toxicity (elevation of serum creatinine levels above the upper limit of normal, measured by mg/dL)

Incidence of symptomatic postural hypotension, diagnosed by clinical assessment of reduction of \> 20 mmHG of arterial systolic pressure after measurement in prone position and orthostatic position.

Death of any cause since protocol enrollment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Retrospective Case Series of COVID19+ Patients Undergoing Orthopedic Surgery	NCT05881343	Coronavirus Inf... Orthopedic Diso... Bone Fracture Bone Metastases Bone Neoplasm		-	Istituto Ortopedico Rizzoli
Early Treatment With Ivermectin and LosarTAN for Cancer Patients With COVID-19 Infection	NCT04447235	Cancer COVID Coronavirus Inf...	Placebo Ivermectin Losartan	18 Years -	Instituto do Cancer do Estado de São Paulo
Early Treatment With Ivermectin and LosarTAN for Cancer Patients With COVID-19 Infection	NCT04447235	Cancer COVID Coronavirus Inf...	Placebo Ivermectin Losartan	18 Years -	Instituto do Cancer do Estado de São Paulo
Retrospective Case Series of COVID19+ Patients Undergoing Orthopedic Surgery	NCT05881343	Coronavirus Inf... Orthopedic Diso... Bone Fracture Bone Metastases Bone Neoplasm		-	Istituto Ortopedico Rizzoli

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