Effectiveness and Safety of Medical Treatment for SARS-CoV-2 (COVID-19) in Colombia
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, COVID-19 drug treatment
Eligibility Criteria
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
Sites / Locations
- Clinica santa Maria del lago
- Clínica Reina Sofía
- Fundacion Cardio Infantil
- Hospital Universitario San Ignacio
- Clinica Universitaria Colombia
- Hospital Universitario Nacional de Colombia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Other
I1 Emtricitabine + Tenofovir
I2 Colchicine + rosuvatatine
I3 Emtricitabine/ tenofobir + colchicine+ rosuvastatin
I4 Standard Treatment
Intervention 1: Emtricitabine (200 mg) + tenofovir (300 mg): 500 mg once a day for 10 days
Intervention 2: Colchicine: 0.5 mg every 12 hours for 14 days + Rosuvatatin: 40 mg / day for 14 days
Intervention 3: Emtricitabine (200 mg) + tenofovir (300 mg): 500 mg once a day for 10 days + Colchicine: 0.5 mg every 12 hours for 14 days + Rosuvatatin: 40 mg / day for 14 days
Intervention 4: Standard treatment. It is defined as treatment aimed to control symptoms including fever and pain, multiple organ failure related to the acute infection including respiratory support (oxygen, positive end-expiration pressure with external devices or invasive ventilatory support), cardiovascular, renal, haematological or coagulation, or co-infection with bacterial or mycotic organisms, standard care to prevent pressure ulcers or other care required by the patient, might include Dexamethasone. No viral therapies are included.