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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04928469
• Other study ID #: 2020-0163
• Status: Completed
• Start date: June 15, 2021
• Est. completion date: July 16, 2021

Study information

• Verified date: July 2021
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: July 16, 2021
• Est. primary completion date: July 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• No intervention performed
Collection of clinical and laboratory data

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of patients in each category in the ordinal scale during hospitalization	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.	28 days from hospital admission
Secondary	Arterial oxygen partial pressure (PaO2)/ Fractional inspired oxygen (FiO2) evolution during hospitalization	Proportion of patients in each category according to PaO2/FiO2 value: 400-301, 300-201, 200-101, <=100.	28 day from hospital admission
Secondary	28-day Mortality from onset of symptoms	Death for any cause from onset of symptoms	28 days from onset of symptoms
Secondary	Time to death from onset of symptoms	Number of days from the onset of symptoms to death	28 days from onset of symptoms
Secondary	28-day Mortality from hospital admission	Death for any cause from hospital admission	28 days from hospital admission
Secondary	Time to death from hospital admission	Number of days from the hospital admission to death	28 days from hospital admission
Secondary	Days alive and free of supplemental oxygen support.	Number of days alive and free of supplemental oxygen support	28 day from hospital admission
Secondary	Time to invasive ventilatory support	Number of days from the onset of symptoms to mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)	28 days from onset of symptoms
Secondary	Need of critical care	Proportion of patients admitted to Intensive Care Unit	28 days from hospital admission
Secondary	In-hospital mortality	Death for any cause during hospitalization	90 days from hospital admission
Secondary	Number of thromboembolic event	Number of patients with documented deep venous thrombosis or pulmonary embolism	28 day from hospital admission
Secondary	Number of patients requiring renal replacement therapy (RRT)	Number of patients requiring any form of RRT during hospitalization	28 day from hospital admission
Secondary	Number of patients requiring prone positioning	Number of patients requiring prone positioning during hospitalization	28 day from hospital admission