Status:
COMPLETED
Effectiveness and Safety of Medical Treatment for SARS-CoV-2 (COVID-19) in Colombia
Lead Sponsor:
Universidad Nacional de Colombia
Collaborating Sponsors:
Pontificia Universidad Javeriana
Clínica Colsanitas-Clínica Universitaria Colombia
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Introduction: The COVID-19 pandemic is characterized by significant morbidity and mortality. Treatments have been administered to patients with COVID-19 in order to control viral infection, among them...
Detailed Description
Initially, the use of the drugs chloroquine, hydroxychloroquine and lopinavir / ritonavir had been proposed in this study, based on laboratory results of their in vitro antiviral potency for the CoV-2...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT04359095
Start Date
August 18 2020
End Date
June 30 2021
Last Update
August 12 2021
Active Locations (6)
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1
Clinica santa Maria del lago
Bogotá, DC, Colombia, 110111
2
Clínica Reina Sofía
Bogotá, Colombia, 110121
3
Fundacion Cardio Infantil
Bogotá, Colombia, 110131
4
Hospital Universitario San Ignacio
Bogotá, Colombia, 110231