Clinical features and natural history of the first 2073 suspected COVID-19 cases in the Corona São Caetano primary care programme: a prospective cohort study
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Abstract
Despite most cases not requiring hospital care, there are limited community-based clinical data on COVID-19.
Methods
The Corona São Caetano programme is a primary care initiative providing care to all residents with COVID-19 in São Caetano do Sul, Brazil. It was designed to capture standardised clinical data on community COVID-19 cases. After triage of potentially severe cases, consecutive patients presenting to a multimedia screening platform between 13 April and 13 May 2020 were tested at home with SARS-CoV-2 reverse transcriptase (RT) PCR; positive patients were followed up for 14 days with phone calls every 2 days. RT-PCR-negative patients were offered additional SARS-CoV-2 serology testing to establish their infection status. We describe the clinical, virological and natural history features of this prospective population-based cohort.
Findings
Of 2073 suspected COVID-19 cases, 1583 (76.4%) were tested by RT-PCR, of whom 444 (28.0%, 95% CI 25.9 to 30.3) were positive; 604/1136 (53%) RT-PCR-negative patients underwent serology, of whom 52 (8.6%) tested SARS-CoV-2 seropositive. The most common symptoms of confirmed COVID-19 were cough, fatigue, myalgia and headache; whereas self-reported fever (OR 3.0, 95% CI 2.4 to 3.9), anosmia (OR 3.3, 95% CI 2.6 to 4.4) and ageusia (OR 2.9, 95% CI 2.3 to 3.8) were most strongly associated with a positive COVID-19 diagnosis by RT-PCR or serology. RT-PCR cycle thresholds were lower in men, older patients, those with fever and arthralgia and closer to symptom onset. The rates of hospitalisation and death among 444 RT-PCR-positive cases were 6.7% and 0.7%, respectively, with older age and obesity more frequent in the hospitalised group.
Conclusion
COVID-19 presents in a similar way to other mild community-acquired respiratory diseases, but the presence of fever, anosmia and ageusia can assist the specific diagnosis. Most patients recovered without requiring hospitalisation with a low fatality rate compared with other hospital-based studies.
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SciScore for 10.1101/2020.06.23.20138081: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: All analyses were conducted in R Software for Statistical Computing, version 3.6.3.14 Ethics: The study was approved by the local ethics committee (Comissão de Ética para Análise de Projeto de Pesquisa - CAPPesq, protocol No. 13915, dated June 03, 2020).
Consent: The committee waived the need for informed consent and allowed the development of an analytical dataset with no personal identification for the current analysis.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable All pregnant women, and patients meeting pre-defined triage criteria for severe disease (see Supplemental Material), were advised to … SciScore for 10.1101/2020.06.23.20138081: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: All analyses were conducted in R Software for Statistical Computing, version 3.6.3.14 Ethics: The study was approved by the local ethics committee (Comissão de Ética para Análise de Projeto de Pesquisa - CAPPesq, protocol No. 13915, dated June 03, 2020).
Consent: The committee waived the need for informed consent and allowed the development of an analytical dataset with no personal identification for the current analysis.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable All pregnant women, and patients meeting pre-defined triage criteria for severe disease (see Supplemental Material), were advised to attend a hospital service - either an emergency department or outpatient service, depending on availability. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Our study has some limitations. Serology was not performed on all RT-PCR negative patients due to on-going symptoms, loss to follow-up, or patient refusal. Of note, none of the RT-PCR-negative patients that were admitted to hospital underwent serology testing. This suggests that patients who were not tested with serology may have had a higher prevalence of COVID-19 than those that were tested. In addition, imperfect serology test performance (81% sensitivity)13 will introduced false-negative results. Taken together, these biases may have underestimated the true seroprevalence among RT-PCR-negative cases, as well as the false-negative rate of RT-PCR. The latter calculation may also have been influenced by the inclusion of RT-PCR positive patients in the denominator, introducing an incorporation bias.22 A key strength to our study relates to the provision of primary healthcare in Brazil and its symbiosis with medical training nationwide. Primary health care - within the family health strategy (Estratégia Saúde da Família) - is cantered around a healthcare unit with a multi-professional team that is responsible for all residents in the immediate catchment area 23. São Caetano do Sul has 100% coverage with the family health strategy, and medical students from the municipal university (USCS) are integrated into the healthcare teams and progressively trained from the first year of medical school. Our initiative took advantage of this existing system, with the addition of an online ...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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