Publication Gaitan-Duarte H, 2021 (preprint)
Dates: 8/18/2020 to 3/20/2021
Funding: Public/non profit (Colombian Ministry of Science and Technology, Universidad Nacional de Colombia, and Pontificia Universidad Javeriana)
Conflict of interest: No
Multicenter / Colombia |
Follow-up duration (days): 28
|Inclusion criteria||Adults aged 18 years or more, with a positive real-time polymerase chain reaction (RT-PCR)
or with high suspicion of SARS CoV-2 by clinical criteria and a diagnosis of mild, severe, or
critical pneumonia, requiring hospital management.
Mild pneumonia was defined by chest X-ray images and 2 or more risk factors for Covid-19 complications, including age over 60 years, previous cardiovascular disease, diabetes mellitus, chronic obstructive pulmonary disease (COPD), or cancer.
Moderate pneumonia was defined by chest X-ray images and hospitalization criteria of the simplified severity scale CRB-65>1 or oxygen saturation at ambient air of less than 90%.
Severe pneumonia was defined with the same criteria as for moderate pneumonia, plus respiratory rate over 30 breaths per minute, or need for mechanical ventilation (invasive or non-invasive), or sepsis identified by a Sequential Organ Failure Assessment (SOFA) score of two or more points or quick SOFA with 2 out of 3 clinical variables, namely, Glasgow 13 or lower, systolic pressure of 100 mmHg or lower and respiratory rate of 22 breaths per minute or higher; or with a diagnosis of Septic Shock or Multiple organ failure or Adult Respiratory Distress Syndrome.
|Exclusion criteria||Pregnant women, patients taking any of the study medications in the last 7 days or with known allergy to them, or with a history of myopathy or rhabdomyolysis, hepatic, or renal failure or lung fibrosis, advanced or metastatic cancer, and those with score more than 3 on the frailty scale|
649 participants n1=163/ n2=162/ n3=161n4=163
|Characteristics of participants|
Mean age : 55.4
Severity : Mild: n=109 / Moderate: n=418/ Severe: n=57 Critical: n=49
|In the register|
Mortality [ Time Frame: Post-intervention at day 28 ]
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 [ Time Frame: Post-intervention at day 28 ]
Number of participants that develop severe adverse events related to the treatment
|In the report|
All-cause mortality within 28 days after randomization; Severe adverse events
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|General comment||In addition to the pre-print article, the prospective registry was used in data extraction and assessment of risk of bias. Neither study protocol nor statistical analysis plan was available. A number of outcomes in the registry were not reported, but none were COVID NMA-specific (number of participants cured assessed by nasopharyngeal swab, oropharyngeal swab, and blood aspiration for COVID19 without clinical symptoms and normal chest X ray at 28 days; mortality up to 28 days after hospital admission; treatment-related SAEs at 7 days; treatment-related AEs at 28 days). Otherwise there were no major differences between the registry and the report. The study did not achieve its target sample size.|