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Trial - RBR-3f8dm6q


Column Value
Trial registration number RBR-3f8dm6q
Full text link
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Ícaro Pires

Contact
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

icaroatp@gmail.com

Registration date
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2022-01-23

Recruitment status
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

unclear

Study aim
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Long covid

Inclusion criteria
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Patients who complain of anosmia or hyposmia after SARS-CoV-2 infection less than 3 months after symptom onset, convalescing from her COVID-19 disease, with onset of disease symptoms for at least 4 weeks, Patients who underwent RT-PCR test at symptom onset, with detection of SARS-CoV-2, Patients who can give valid written informed consent, Patients motivated to participate in the study, Adult patients aged 18-60 years.

Exclusion criteria
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Patients who cannot give valid written informed consent, Patients with a previous history of more than one SARS-CoV-2 infection Patients with nasosinusal diseases such as chronic rhinosinusitis or nasal masses, History of previous traumatic brain injury with olfactory sequelae, History of olfaction disorder prior to SARS CoV-2 infection, Patients with any diagnosed neurological disease known to affect olfactory function, Patients unable to read Portuguese, Patients who are already using an oral glucocorticoid, Patients who have already started some form of therapy for the olfactory disorder caused by COVID-19, Known hypersensitivity to any item used in any of the proposed olfactory training,

Number of arms
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Complexo Hospital de Clínicas da Universidade Federal do Paraná

Inclusion age min
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

60

Countries
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Brazil

Type of patients
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Patients recovered from covid

Severity scale
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

N/A

Total sample size
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

0

primary outcome
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

The primary outcome assessed will be improvement in olfaction (periods 4; 12; 24 and 52 weeks after starting treatment). The evaluation of smell is based on the comparison of results from before and after the olfactory rehabilitation obtained from a single method of the two methods: olfactory identification results obtained from the University of Pennsylvania Smell Identification Test (UPSIT); Subjective assessment of patients using a visual analogue scale for the following complaints: loss of ability to smell; loss of ability to sense flavors; nasal symptoms in the last 14 days; how much the difficulty in smelling bothers; how much the difficulty in feeling flavors bothers.

Notes
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Arms
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 2163, "treatment_name": "Modified olfactory training (12 essential oils)", "treatment_type": "Olfactory training", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 919, "treatment_name": "Olfactory training", "treatment_type": "Olfactory training", "pharmacological_treatment": "Non pharmacological treatment"}]