Created at Source Raw Value Validated value
May 5, 2022, 11:30 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Subjects were enrolled after obtaining written informed consent and were screened for eligibility for the study based on inclusion and exclusion criteria. For confirmation of COVID-19; subjects underwent Reverse transcription polymerase chain reaction (RT-PCR) test. Only those subjects who had laboratory-confirmed diagnosis of COVID-19 at the time of screening (Day -3 to 0) using RT-PCR method and who met all eligibility criteria were enrolled. Along with viral load values from RT-PCR test; cycle threshold (CT) value was also included in the laboratory reports. Subjects with COVID-19 were randomized into this study with Covixyl-V LAEH nasal spray and placebo nasal spray. Subjects were randomized in a 1:1 proportion to receive either LAEH formulation or matching placebo twice daily. Subjects were instructed to use the assigned treatment as nasal spray (2 to 3 puffs in each nostril at a time) twice a day from Day 1 to Day 5 and only once in the morning on Day 6. Subjects were instructed to refrain from eating; drinking; or using any nasal gavage at least 30 minutes prior to use of nasal spray. Subjects were also informed that the daily second treatment should be taken approximately 6 hours after the first treatment. The site personnel explained the effective use of the nasal spray in a step-by-step manner and documented the same training in the source documents. The subjects were instructed to record his/her initials and date and time he/she administered the assigned treatment on a daily basis in the subject diary. On Day 6/end of study (EOS); all the subjects took the first treatment (11th dose) at home around 8:00 am and then visited their respective site as instructed. Then the site performed the viral load enumeration u", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 2469, "treatment_name": "Ethyl lauroyl arginate hydrochloride [laeh]", "treatment_type": "Nasal spray", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]