Clinical trial NCT04928469: Clinical Impact of COVID-19 by P.1 SARS-CoV-2 Lineage
Official title: Clinical Impact of Coronavirus Disease 19 (COVID-19) Caused by P.1 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Lineage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
COVID-19 Pneumonia
SARS-CoV-2 Infection
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
First posted: 2021-06-16
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18 to 65 years, seeking medical care in Hospital de Clínicas de Porto Alegre due to symptomatic COVID-19, admitted from June to November 2020 or from February to May 2021.

Brief summary: Since the first report of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant of concern (VOC) P.1 in Manaus, Brazil, a rapid spread of this lineage across the country has been observed. Recent studies indicate that this variant is associated with higher transmissibility; it is not known whether it is associated with clinical severity and higher mortality rates.

This is a retrospective cohort study carried out at Hospital de Clínicas de Porto Alegre. Adult patients aged 18 years or more and 65 years or less who were admitted to the hospital due to symptomatic COVID-19 from June 2020 to May 2021 and had a reverse transcriptase-polymerase chain reaction (RT-PCR) cycle threshold value for either SARS-CoV-2 N1 or N2 target ≤ 25 were eligible to the study. Samples from 86 patients (43 from June 2020 to November 2020 and 43 from February 2021 to May 2021) were sequenced for further evaluation. These dates were defined since the emergence of P.1 lineage in late January.

Clinical data regarding ventilatory support, date of onset of symptoms, laboratory findings and mortality were collected from each patient. This retrospective cohort aims to assess whether the number of days needed for supplementary oxygen either by noninvasive ventilation or high-flow nasal cannula from onset of symptoms differs among patients infected with the P.1 SARS-CoV-2 variant and those infected with other variants.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 65 years
* Hospital admission due to symptomatic COVID-19
* RT-PCR was collected from June to November 2020 or from February to May 2021

Exclusion Criteria:

* Patients admitted for reasons other than COVID-19
* Asymptomatic patients with positive routine screening with RT-PCR
* Patients transferred from other institutions

Primary outcomes:
measure: Time to Advanced Respiratory Support
timeFrame: 28 days from onset of symptoms
Secondary outcomes:
measure: Proportion of patients in each category in the ordinal scale during hospitalization
timeFrame: 28 days from hospital admission
measure: Arterial oxygen partial pressure (PaO2)/ Fractional inspired oxygen (FiO2) evolution during hospitalization
timeFrame: 28 day from hospital admission
measure: 28-day Mortality from onset of symptoms
timeFrame: 28 days from onset of symptoms
measure: Time to death from onset of symptoms
timeFrame: 28 days from onset of symptoms
measure: 28-day Mortality from hospital admission
timeFrame: 28 days from hospital admission
measure: Time to death from hospital admission
timeFrame: 28 days from hospital admission
measure: Days alive and free of supplemental oxygen support.
timeFrame: 28 day from hospital admission
measure: Time to invasive ventilatory support
timeFrame: 28 days from onset of symptoms
measure: Need of critical care
timeFrame: 28 days from hospital admission
measure: In-hospital mortality
timeFrame: 90 days from hospital admission
measure: Number of thromboembolic event
timeFrame: 28 day from hospital admission
measure: Number of patients requiring renal replacement therapy (RRT)
timeFrame: 28 day from hospital admission
measure: Number of patients requiring prone positioning
timeFrame: 28 day from hospital admission
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
References: