NCT04959747.

Study name	Acupuncture for olfactory dysfunction in infected COVID‐19 patients
Methods	Two‐arm, single‐blinded (to the participant), cross‐over RCT with 4 weeks duration of treatment, followed by 2 weeks of follow‐up, then cross‐over to the opposite group
Participants	Adult participants, with moderate to severe olfactory dysfunction following COVID‐19 Inclusion criteria: Previously diagnosed with COVID‐19 Post‐COVID‐19 olfactory dysfunction with moderate to severe symptoms (based on UPSIT score of ≤ 29.5 for males and ≤ 30.5 for females) Have not undergone treatment for olfactory dysfunction No history of trauma, injury or surgery to the head or nose, nor any bleeding from the nose Aged 18 to 80 years and able to read and write Chinese Exclusion criteria: Olfactory or gustatory dysfunction before the pandemic Chronic rhinosinusitis or nasal polyposis Previous nasal surgery Pregnant or breastfeeding women Cancers, neurological disorders (e.g. Alzheimer's or Parkinson's) or other serious medical conditions Unstable medical conditions In receipt of acupuncture treatment within one month Alcoholism or drug abuse in the past year Needle phobic History of severe adverse reaction to acupuncture Estimated sample size: 20 participants
Interventions	Intervention group: Body acupuncture will involve 8 acupoints as Yingxiang (LI20), Shangxing (GV23), BiTong, Yintang, Hegu. A disposable acupuncture needle (0.25 mm in diameter and 25 mm to 30mm in length) will be inserted at a depth of 10 mm to 25 mm obliquely into scalp acupuncture points (ShangXing, YinTang) and straight into face/body acupuncture points (Yingxiang, BiTong, Hegu). Electro‐acupuncture will be applied to the face points at fast and dispersed waves through an electric needle stimulator for 30 minutes. Participants will undergo a total of 8 sessions, 30 minutes per session, delivered twice per week over a 4‐week period.  Comparator group: Sham control. Streitberger's non‐invasive acupuncture needles (Gauge 8 x 1.2"/0.30 mm x 30 mm) will be applied to serve as sham control at the same acupuncture points
Outcomes	Outcomes of interest in the review: Primary outcomes: Presence of normal olfactory function UPSIT score (range 0 to 40) will be used. It is not clear if this will be reported as a dichotomous or continuous outcome. Time frame: 14 weeks. Assessment of Subjective Olfactory function Tool (ASOF) will be used to assess olfactory capability and quality of life. This includes a 0 to 10 VAS score of subjective olfactory capability (0 = unable to smell, 10 = best possible sense of smell). It also includes a 5‐item assessment of ability to detect odours (5 different odour scenarios, each rated 1 to 5, higher scores = better, summed score is a simple average). Unclear if this will be reported as a continuous or dichotomous outcome. Serious adverse effects Not reported Change in sense of smell UPSIT score (range 0 to 40) will be used. It is not clear if this will be reported as a dichotomous or continuous outcome. Time frame: 14 weeks. Assessment of Subjective Olfactory function Tool (ASOF) will be used to assess olfactory capability and quality of life. This includes a 0 to 10 VAS score of subjective olfactory capability (0 = unable to smell, 10 = best possible sense of smell). It also includes a 5‐item assessment of ability to detect odours (5 different odour scenarios, each rated 1 to 5, higher scores = better, summed score is a simple average). Unclear if this will be reported as a continuous or dichotomous outcome. Secondary outcomes: Prevalence of parosmia Not reported Change in sense of taste Not reported Disease‐related quality of life Assessment of Subjective Olfactory function Tool (ASOF) will be used to assess olfactory capability and quality of life. This includes a 6‐item assessment of impairment due to problems with olfaction (6 different situations, each rated 1 to 5, higher scores = better, summed score is a simple average). The short version of the QOD‐ND will also be used. 7 items, each scored 0 to 3, total score range 0 to 21, higher scores = better Other adverse effects (including nosebleeds/bloody discharge) Not reported Other outcomes reported by the study: None reported
Starting date	15 July 2020
Contact information	Alfred‐Marc Iloreta Email: alfred‐marc.iloreta@mountsinai.org
Notes	Estimated study completion date: June 2021 It is unclear from the description of this trial whether participants will have symptoms of olfactory disturbance for fewer than 4 weeks from the onset of COVID‐19. Correspondence with the study team has confirmed that they will recruit a mixed population, comprising individuals with fewer than and longer than 4 weeks of symptoms.