NCT04638673.

Study name	NeuroCovid rehab and recovery related to COVID‐19 diagnosis
Methods	To evaluate a transcutaneous auricular vagus nerve stimulation (taVNS) in the treatment of the neurological symptoms of COVID‐19 termed NEUROCOVID
Participants	Patients with COVID‐19 suffering from the neurological symptoms associated with infection Inclusion criteria: COVID‐positive At home Afebrile Anxiety Depression Vertigo Anosmia Headaches Irritability Cognitive processing Exclusion criteria: Damage to left ear anatomy Unstable haemodynamic effects Ischaemic or haemorrhagic stroke after developing COVID Unable to give consent, follow instructions Unable to read or write or speak English No access to home WiFi Planned sample size: estimated enrolment 30 participants
Interventions	Intervention group Active‐Active Stimulation Group Participants will receive active taVNS stimulation for weeks 1 to 4 of the stimulation portion of this study using Soterix taVNS model 0125‐LTE Comparator Group Sham‐Active Stimulation Group Participants will receive sham taVNS stimulation for weeks 1 and 2 and active stimulation for weeks 3 and 4 of the stimulation portion of this study
Outcomes	Outcomes of interest in the review: Primary outcomes: Recovery of sense of smell Not reported Disease‐related quality of life The primary outcome was change in score of Patient Health Questionnaire‐9 from baseline to week 4 (end of treatment)  The PPHQ‐9 is a 9‐question instrument given to patients in a primary care setting to screen for the presence and severity of depression. Scores range from 0 to 27. Higher scores mean worse symptoms. For the purpose of this study: remission: minimal to absence of symptoms; PHQ‐9 score < 5; response: 50% or greater decrease in PHQ‐9 baseline severity; residual symptoms remain; partial response: 26% to 49% decrease in PHQ‐9 baseline severity;  non‐response: less than 25% decrease in PHQ‐9 baseline severity. Serious adverse effects  Not reported Secondary outcomes: Change in sense of smell Not reported Overall, generic quality of life Not reported Prevalence of parosmia Not reported Other adverse effects (including nosebleeds/bloody discharge) Not reported Other outcomes reported by the study: None reported
Starting date	19 November 2020
Contact information	Sarah Huffman Email: huffmans@musc.edu Morgan Dancy Email: maddoxm@musc.edu
Notes	Estimated study completion date: June 2021  Trial registered in USA Uncertainty over future inclusion in the review: It is not clear from the description provided whether participants will all have olfactory dysfunction at baseline and, if so, whether they will have had ≥ 4 weeks of olfactory dysfunction. We are awaiting confirmation from the study authors.