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

NCT04928469 | Completed

• 1 other identifier: 2020-0163
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; COVID-19 Pneumonia; SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Proportion of patients in each category in the ordinal scale during hospitalization

  28 days from hospital admission

• Arterial oxygen partial pressure (PaO2)/ Fractional inspired oxygen (FiO2) evolution during hospitalization

  28 day from hospital admission

• 28-day Mortality from onset of symptoms

  28 days from onset of symptoms

• Time to death from onset of symptoms

  28 days from onset of symptoms

• 28-day Mortality from hospital admission

  28 days from hospital admission

Study Arms (2)

P.1

Patients infected with the P.1 SARS-CoV-2 variant

Other: No intervention performed

Other variants

Patients infected with SARS-CoV-2 variants other than P.1

Other: No intervention performed

Interventions

No intervention performed OTHER

Collection of clinical and laboratory data

Other variants; P.1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

RT-PCR positive for SARS-CoV-2

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2021
• First Posted: June 16, 2021
• Study Start: June 15, 2021
• Primary Completion: July 16, 2021
• Study Completion: July 16, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)