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

NCT04928469 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2021-07-20

No results posted yet for this study

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

Interventions

OTHER

No intervention performed

Collection of clinical and laboratory data

Sponsors & Collaborators

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

    collaborator OTHER

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-15
Primary Completion
2021-07-16
Completion
2021-07-16

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04928469 on ClinicalTrials.gov