Clinical Impact of COVID-19 by P.1 SARS-CoV-2 Lineage

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Impact of Coronavirus Disease 19 (COVID-19) Caused by P.1 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Lineage

Conditions
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Covid19, COVID-19 Pneumonia, SARS-CoV-2 Infection

Intervention / Treatment
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* Other: No intervention performed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| P.1<br>Patients infected with the P.1 SARS-CoV-2 variant | Other: No intervention performed<br>* Collection of clinical and laboratory data<br>|
| Other variants<br>Patients infected with SARS-CoV-2 variants other than P.1 | Other: No intervention performed<br>* Collection of clinical and laboratory data<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Advanced Respiratory Support | Number of days needed for supplementary oxygen either by noninvasive ventilation or high-flow nasal cannula from onset of symptoms. | 28 days from onset of symptoms | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients in each category in the ordinal scale during hospitalization | Proportion of patients in each category in the ordinal scale during hospitalization. Ordinal scale levels: 1, patient not hospitalized; 2, hospitalized and not receiving supplemental oxygen; 3, hospitalized and receiving supplemental oxygen; 4, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 5, hospitalized and receiving mechanical ventilation or extracorporeal membrane oxygenation; and 6, death. | 28 days from hospital admission | 
| Arterial oxygen partial pressure (PaO2)/ Fractional inspired oxygen (FiO2) evolution during hospitalization | Proportion of patients in each category according to PaO2/FiO2 value: 400-301, 300-201, 200-101, <=100. | 28 day from hospital admission | 
| 28-day Mortality from onset of symptoms | Death for any cause from onset of symptoms | 28 days from onset of symptoms | 
| Time to death from onset of symptoms | Number of days from the onset of symptoms to death | 28 days from onset of symptoms | 
| 28-day Mortality from hospital admission | Death for any cause from hospital admission | 28 days from hospital admission | 
| Time to death from hospital admission | Number of days from the hospital admission to death | 28 days from hospital admission | 
| Days alive and free of supplemental oxygen support. | Number of days alive and free of supplemental oxygen support | 28 day from hospital admission | 
| Time to invasive ventilatory support | Number of days from the onset of symptoms to mechanical ventilation or Extracorporeal membrane oxygenation (ECMO) | 28 days from onset of symptoms | 
| Need of critical care | Proportion of patients admitted to Intensive Care Unit | 28 days from hospital admission | 
| In-hospital mortality | Death for any cause during hospitalization | 90 days from hospital admission | 
| Number of thromboembolic event | Number of patients with documented deep venous thrombosis or pulmonary embolism | 28 day from hospital admission | 
| Number of patients requiring renal replacement therapy (RRT) | Number of patients requiring any form of RRT during hospitalization | 28 day from hospital admission | 
| Number of patients requiring prone positioning | Number of patients requiring prone positioning during hospitalization | 28 day from hospital admission |