Created at Source Raw Value Validated value
Feb. 25, 2022, noon oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Phase 2a is a double blinded randomised controlled trial involving 100 patients- To assess whether nasal delivery of an Interferon (IFN -1)/ Hyaluronic Acid formulation improves clinical course of COVID-19 infection and viral clearance through clinical and virological measures.- To monitor safety and acceptability of the nasal spray- To monitor disease progression and immunological markersArm 1 (treatment) - Interferon + hyaluronic acid nasal sprayRoute of administration: Nasal spray; both nostrilsFrequency of administration: Twice daily for five daysDose administered: 0.28 ml sprayed into each nostrilIntervention: Test article will be 1.0ml/24M IU IFN\u00df1a (2X (0.5ml/12M IU) Rebif 44) in 5.5ml of 3% micronized crosslinked sodium hyaluronate.Total dose administered: The cumulative dose will be 76mcg/20.6M IU IFN in 3% hyaluronic acid (HA) suspension.Arm 2 (placebo) - hyaluronic acid nasal sprayRoute of administration: Nasal spray; both nostrilsFrequency of administration: Twice daily for five daysDose administered: 0.28 ml sprayed into each nostrilIntervention: Solution of 3% micronized crosslinked sodium hyaluronate vehicle. Total dose administered: The cumulative dose will be 5.6 ml of a 3% hyaluronic acid (HA) suspension.Standardised clinical assessment (may be performed virtually) will occur at baseline (pre-randomisation; 7 days; 2 weeks; 4 weeks post-randomisation). Nasopharyngeal swabs will be obtained at day 0 and 7 to detect and quantify viral load and daily self-collected salivary samples will be collected.Patients will be virtually contacted by a Clinical Trials Nurse to ensure compliance during the treatment program as well as follow up at trial completion", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 2218, "treatment_name": "Hyaluronic acid nasal spray+interferon", "treatment_type": "Nasal spray+interferons", "pharmacological_treatment": "Non pharmacological treatment+pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]