COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05618483

Isaac John, PhD

Isaac.John@metanoichealth.com

2022-11-16

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

inclusion criteria: capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol; adult aged ≥18 years old with at least two comorbidities: diabetes (type 1 &2), obesity (bmi >30), hypertension, chronic heart disease, chronic pulmonary disease, chronic liver disease. internet access and capability and willingness to participate in audio or audio/video engagements with medical professionals, receive texts, emails, and phone calls from study staff and have a device and reasonable cellular data or other internet access to submit daily study required information using a smart phone, tablet, laptop, or desktop computer during the study period; covid-19 infection confirmed with a laboratory sars-cov-2 rt-pcr nasal swab; specimen collected within the past 48 hours; mild covid-19 symptoms which may include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, lack of taste or smell without shortness of breath

not fit to consent and unable to follow the protocol; age <18 years; current tracheostomy or laryngectomy; hypersensitivity to the active substance or to any of the excipients; concomitant respiratory therapy such as oxygen or ventilator support. positive airway pressure for obstructive sleep apnea is permitted if treatment was established with good compliance at least 3 months before enrolment; need for hospitalisation for any reason; inability to safely self-administer nasal spray any clinical contraindications, as judged by the qualified medical practitioner; clinical signs indicative of moderate, severe or critical covid severity symptoms (as defined by fda covid-19 guidance document) mentally or neurologically disabled patients who are considered not fit to consent to their participation in the study; lactating, pregnant or planning to become pregnant during the study period; diagnosed with prior covid-19 infection (>48 hours from the time the test is reported prior to the time of screening). no relevant comorbidity or only one comorbidity

2

Xlear, Inc

18

100

None

Mild disease at enrollment

1: Mild disease at enrollment

80

Viral load reduction

None

Not reported

[{"arm_notes": "nan", "treatment_id": 1394, "treatment_name": "Xylitol", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]