Table 2 Protocol for home-visit procedures and data collection
Procedures | |
|---|---|
Day 1 | Medical history Brief physical examination Vital signs (forehead temperature, pulse, blood pressure, pulse oximetry) Document weight and height Review baseline symptoms, if applicable Document concomitant medications and therapies Baseline adverse event assessment Saliva sample collection Nasal brushing for transcriptomics Nasal lining fluid sampling for IgA Blood sample collection (2 tbsp; about 30 ml) Dispense and instruct on use of diary cards Dispense individual thermometers for each participant Urine sample collection and pregnancy test pack, if applicable Administer acetaminophen 1000 mg PO pre-medication, if applicable Study drug administration, if applicable Observation for 20 min post study drug administration, if applicable General education to patients and family members about COVID-19 standard care |
Day 6 | Brief physical examination Vital signs (forehead temperature, pulse, blood pressure, pulse oximetry) prior to study drug administration Review adverse events Review concomitant medications Saliva sample collection (immediately prior to study drug administration) Nasal lining fluid sampling for IgA Blood sample collection (2 tbsp; about 30 mL) Urine sample collection and pregnancy test pack, if applicable Administer acetaminophen 1000 mg PO pre-medication, if applicable Study drug administration, if applicable Collect completed diary cards and dispense new diary cards Observation for 20 min post study drug administration, if applicable |
Day 11 | Brief physical examination Vital signs (forehead temperature, pulse, blood pressure, pulse oximetry) prior to study drug Review adverse events Review concomitant medications Collect completed diary cards and dispense new diary cards Saliva sample collection (immediately prior to study drug administration) Nasal lining fluid sampling for IgA Blood sample collection (2 tbsp; about 30 ml) Urine sample collection and pregnancy test pack, if applicable Administer acetaminophen 1000 mg PO pre-medication, if applicable Study drug administration, if applicable 12) Observation for 20 min post study drug administration, if applicable |
Day 16 & 21 (± 24 h) | Diary completion Saliva sample collection |
Day 29 (± 24 h) | Brief physical examination Vital signs (forehead temperature, pulse, blood pressure, pulse oximetry) Review adverse events Review concomitant medications Collect completed diary cards Blood sample collection Saliva sample collection Closure of study |