Table 1.
Patient Demographics, baseline clinical characteristics and virucidal activity of PVI-P Nasal spray and mouth wash
| Nasal irrigation (NI) | p-value | ||||||
|---|---|---|---|---|---|---|---|
| .4% NI | .5% NI | .6% NI | Control-NI (CNI) | .4% NI v CNI | .5% NI v CNI | .6% NI v CNI | |
| Age group | |||||||
| 18–30 | 4 (14.8) | 7 (25.9) | 3 (11.1) | 3 (11.1) | 0.787a | 0.548a | 0.750a |
| 31–40 | 6 (22.2) | 9 (33.3) | 5 (18.5) | 9 (33.3) | |||
| 41–50 | 11 (40.7) | 3 (11.1) | 7 (25.9) | 8 (29.6) | |||
| 51–60 | 6 (22.2) | 6 (22.2) | 8 (29.6) | 5 (18.5) | |||
| 61–70 | 0 | 1 (3.7) | 3 (11.1) | 1 (3.7) | |||
| > 70 | 0 | 1 (3.7) | 1 (3.7) | 1 (3.7) | |||
| Sex | |||||||
| Male | 23 (85.2) | 23 (85.2) | 20 (74.1) | 21 (77.8) | 0.484a | 0.484b | 0.750 b |
| Female | 4 (14.8) | 4 (14.8) | 7 (25.9) | 6 (22.2) | |||
| Disease severity | |||||||
| Asymptomatic | 1 (3.7) | 2 (7.4) | 2 (7.4) | 0 | 1.00a | 0.075a | 0.781a |
| Mild | 12 (44.4) | 6 (22.2) | 12 (44.4) | 12 (44.4) | |||
| Moderate | 14 (51.9) | 19 (70.4) | 12 (44.4) | 14 (51.9) | |||
| Severe | 0 | 0 | 1 (3.7) | 1 (3.7) | |||
| Co-morbidities | |||||||
| At least one | 16 (59.3) | 14 (51.9) | 13 (48.1) | 11 (40.7) | 0.174 b | 0.413 b | 0.584 b |
| None | 11 (40.7) | 13 (48.1) | 14 (51.9) | 16 (59.3) | |||
| Disease duration (days) | 2.04 ± 0.72 | 1.92 ± 0.74 | 1.65 ± 0.63 | 1.85 ± 0.61 | 0.305c | 0.686c | 0.269c |
| Outcome | |||||||
| COVID Negative | 18 (33.3) | 25 (92.6) | 23 (85.2) | 8 (29.6) | 0.006 b | < 0.001b | 0.018 b |
| COVID Positive | 9 (33.3) | 2 (7.4) | 4 (14.8) | 19 (70.4) | |||
| Adverse event | |||||||
| Present | 2 (7.4) | 0 | 0 | 0 | 0.493b | NA | NA |
| Absent | 25 (92.6) | 27 (100) | 27 (100) | 23 (100) | |||
| Nasal spray (NS) | p-value | Total | ||||
|---|---|---|---|---|---|---|
| .5% NS | .6% NS | Control-NS (CNS) | .5% NS v CNS | .6% NS v CNS | ||
| Age group | ||||||
| 18–30 | 3 (11.1) | 3 (11.1) | 2 (7.4) | 0.179 a | 0.095 a | 25 (13.2) |
| 31–40 | 6 (22.2) | 8 (29.6) | 13 (48.1) | 56 (29.6) | ||
| 41–50 | 7 (25.9) | 6 (22.2) | 8 (29.6) | 50 (26.5) | ||
| 51–60 | 9 (33.3) | 5 (18.5) | 3 (11.1) | 42 (22.2) | ||
| 61–70 | 1 (3.7) | 4 (14.8) | 0 | 10 (5.3) | ||
| > 70 | 1 (3.7) | 1 (3.7) | 1 (3.7) | 6 (3.2) | ||
| Sex | ||||||
| Male | 25 (92.6) | 27 (100.0) | 20 (74.1) | 0.142b | 0.010b | 159 (84.1) |
| Female | 2 (7.4) | 0 | 7 (25.9) | 30 (15.9) | ||
| Disease severity | ||||||
| Asymptomatic | 1 (3.7) | 2 (7.4) | 5 (18.5) | < 0.001b | < 0.001b | 13 (6.9) |
| Mild | 9 (33.3) | 7 (25.9) | 22 (81.5) | 80 (42.3) | ||
| Moderate | 17 (63.0) | 17 (63.0) | 0 | 93 (49.2) | ||
| Severe | 0 | 1 (3.7) | 0 | 3 (1.6) | ||
| Co-morbidities | ||||||
| At least one | 11 (40.7) | 9 (33.) | 17 (63.0) | 0.102 b | 0.029 b | 91 (48.1) |
| None | 16 (59.3) | 18 (66.7) | 10 (37.0) | 98 (51.9) | ||
| Disease duration (days) | 1.87 ± 0.54 | 1.92 ± 0.97 | 1.79 ± 0.78 | 0.668c | 0.626c | 1.86 ± 0.72 |
| Outcome | ||||||
| COVID Negative | 18 (66.7) | 22 (81.5) | 2 (7.4) | < 0.001d | < 0.001e | 116 (61.4) |
| COVID Positive | 9 (33.3) | 5 (18.5) | 25 (92.6) | 73 (38.6) | ||
| Adverse event | ||||||
| Present | 0 | 0 | 0 | NA | NA | 2 (1.1) |
| Absent | 27 (100) | 27 (100) | 27 (100) | 185 (98.9) | ||
Bold indicates significant 'p' value < 0.05%
Comorbidities included Diabetes Mellitus, Hypertension, Bronchial Asthma and Ischemic Heart Disease
Outcome was defined as RT-PCR negativity for COVID after intervention
Only adverse event was ‘Irritation’
ap-value was determined by Fisher Exact Test
bChi-square Test
cIndependent Samples t Test
dMultivariate Logistic Regression adjusting for Severity
eSeverity and Comorbidity