COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04359095

Hernando G Gaitán-Duarte

hggaitand@unal.edu.co

2020-04-24

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: eligibility criteria for institutions: centralized pharmacy department which allows safe storage of drugs centralized pharmacy department that follows good clinical practice protocols for investigation and either icu capacity of at least 10 beds with available ventilatory support (volume) or intermediate care unit with at least 10 beds with partial ventilatory support inclusion criteria for participants: - age 18 years or over - positive rt-pcr for covid-19 or high suspicion of sars covid 19 - requirement of in-hospital treatment, classified in any of the following categories: mild pneumonia, defined as: - confirmed pneumonia with chest x-rays and at least 2 of the following risk factors or complications: age 60 years or over history of cardiovascular disease history of diabetes mellitus (dm) history of chronic obstructive pulmonary disease (copd) history of hypertension (ht) cancer or moderate pneumonia, defined as : - confirmed pneumonia with chest x-rays and either - criteria for in-hospital management according to the simplified confusion- respiratory rate- blood pressure- age scale (crb-65 scale) score greater than 1 or oxygen saturation lower than 90 percent without supplementary oxygen. or severe pneumonia, sepsis or septic shock, defined as: confirmed pneumonia with chest x-rays and either criteria for in-hospital management according to the simplified crb-65 scale (score greater than 1) or oxygen saturation lower than 90 percent without supplementary oxygen and any of the following: respiratory rate greater than 30 per minute need for mechanical ventilation (invasive or non-invasive) sepsis defined as organic dysfunction which can be identified by a sequential organ failure assessment score (sofa score) of at least 2 points quick sequential organ failure assessment score (qsofa) score with 2 of the following criteria: glasgow of 13 or lower, systolic blood pressure of 100 mmhg or lower and respiratory rate equal to or higher than 22 per minute arterial hypotension which persists after hydric resuscitation and requires vasopressors to maintain a mean arterial pressure greater than 65 mmhg and lactate lesser than 2 mmol/l (18 mg/dl) without hypovolemia (referred as septic shock) multiple organ failure acute respiratory distress syndrome (radiological findings compatible with bilateral infiltrates and oxygenation deficit classified as: mild (pao2/fio2 between 200 and 300), moderate (pao2/fio2 between 100 and 200) or severe (pao2/fio2 lower than 100)). exclusion criteria for participants: pregnancy known allergies to the drugs under study hepatic cirrhosis (child b or c) or hepatic abnormality manifested as transaminase levels 5 times above reference values glomerular filtration rate lesser than 30 ml/min/1.73^m2 by chronic kidney disease epidemiology collaboration (ckd-epi) formula advanced or metastatic cancer fatigue, resistance, ambulation, illnesses, and loss of weight questionnaire (frail) score of fragility greater than 3

None

4

Universidad Nacional de Colombia

18

None

Colombia

No restriction on type of patients

0: No restriction on type of patients

650

Number of Participants with Treatment Related Severe Adverse Events as Assessed by the NCORP Guidance for Collection of Adverse Events Related to COVID-19 Infection;Mortality

None

Phase 2/Phase 3

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