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

NCT ID: NCT04928469

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2021-07-16

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

P.1

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

No intervention performed

Intervention Type: OTHER

Collection of clinical and laboratory data

Other variants

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

No intervention performed

Intervention Type: OTHER

Collection of clinical and laboratory data

Interventions

No intervention performed

Collection of clinical and laboratory data

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

OTHER

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Alexandre Prehn Zavascki

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Study Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-0163

Identifier Type: -

Identifier Source: org_study_id