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Completed

NCT Number: NCT04928469

Clinical Impact of COVID-19 by P.1 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Clínicas de Porto Alegre

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention performed

Other

Collection of clinical and laboratory data

Primary outcomes

  1. Time to Advanced Respiratory Support

    Time frame: 28 days from onset of symptoms

    Number of days needed for supplementary oxygen either by noninvasive ventilation or high-flow nasal cannula from onset of symptoms.

Secondary outcomes

  1. Proportion of patients in each category in the ordinal scale during hospitalization

    Time frame: 28 days from hospital admission

    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.

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

    Time frame: 28 day from hospital admission

    Proportion of patients in each category according to PaO2/FiO2 value: 400-301, 300-201, 200-101, <=100.

  3. 28-day Mortality from onset of symptoms

    Time frame: 28 days from onset of symptoms

    Death for any cause from onset of symptoms

  4. Time to death from onset of symptoms

    Time frame: 28 days from onset of symptoms

    Number of days from the onset of symptoms to death

  5. 28-day Mortality from hospital admission

    Time frame: 28 days from hospital admission

    Death for any cause from hospital admission

  6. Time to death from hospital admission

    Time frame: 28 days from hospital admission

    Number of days from the hospital admission to death

  7. Days alive and free of supplemental oxygen support.

    Time frame: 28 day from hospital admission

    Number of days alive and free of supplemental oxygen support

  8. Time to invasive ventilatory support

    Time frame: 28 days from onset of symptoms

    Number of days from the onset of symptoms to mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)

  9. Need of critical care

    Time frame: 28 days from hospital admission

    Proportion of patients admitted to Intensive Care Unit

  10. In-hospital mortality

    Time frame: 90 days from hospital admission

    Death for any cause during hospitalization

  11. Number of thromboembolic event

    Time frame: 28 day from hospital admission

    Number of patients with documented deep venous thrombosis or pulmonary embolism

  12. Number of patients requiring renal replacement therapy (RRT)

    Time frame: 28 day from hospital admission

    Number of patients requiring any form of RRT during hospitalization

  13. Number of patients requiring prone positioning

    Time frame: 28 day from hospital admission

    Number of patients requiring prone positioning during hospitalization

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 16, 2021
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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