NCT04928469|Completed
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
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Clinical Impact of Coronavirus Disease 19 (COVID-19) Caused by P.1 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Lineage
Sponsor study identifier
observational
86
1 country
1
Study Start
June 15, 2021
Actual (reported)Primary Completion
July 16, 2021
Actual (reported)Study Completion
July 16, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 16, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 13, 2021
Actual (reported)June 15, 2021
Actual (reported)June 16, 2021
Actual (reported)July 16, 2021
Actual (reported)July 16, 2021
Actual (reported)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
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
Patients infected with the P.1 SARS-CoV-2 variant
Patients infected with SARS-CoV-2 variants other than P.1
Collection of clinical and laboratory data
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
RT-PCR positive for SARS-CoV-2
86 participants (actual enrollment reported by the registry).
First Submitted
June 13, 2021
First Posted
June 16, 2021
Study Start
June 15, 2021
Actual (reported)The Aerobic Exercise Capacity and Muscle Strenght in Individuals With COVID-19
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Primary Completion
July 16, 2021
Actual (reported)Study Completion
July 16, 2021
Actual (reported)Last Updated
July 20, 2021
Record last verified: 2021-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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