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

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; SARS-CoV-2 Infection; COVID-19 Pneumonia
• Intervention / Treatment: Other: No intervention performed

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
P.1; Patients infected with the P.1 SARS-CoV-2 variant	Other: No intervention performed; Collection of clinical and laboratory data
Other variants; Patients infected with SARS-CoV-2 variants other than P.1	Other: No intervention performed; Collection of clinical and laboratory data

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Actual): July 16, 2021
• Study Completion (Actual): July 16, 2021

Study Registration Dates

• First Submitted: June 13, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 16, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020-0163

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Statistical Analysis Plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No