Table 4.
Comparison of primary and secondary outcomes
| Outcomes | Arm 1: HCQ + SOC |
Arm 2: SOC alone |
P-value |
|---|---|---|---|
| Number randomized and analyzed (intention-to-treat population)a | 55 | 50 | 105 |
| Median (IQR) Time (in days) to SARS COV-2 viral load clearance by day 6b,c | 4 (3–4) | 4 (2–4) | 0.457 |
| Total person-time of follow-up (in days) | 295 | 251 | N/A |
| Number of patients with viral load clearance by day 6 | 20 | 19 | N/A |
| Rate of viral load clearance per 100 person-days (95%CI) | 6.8 (4.4–10.5) | 7.6 (4.8–11.7) | N/A |
| Sensitivity analysis (on viral clearance) adjusted analysis—Hazard Ratio (95% CI)d | 0.84 (0.44–1.61) | 0.607 | |
| Proportion PCR negative conversion by day 6, n(%) | 20 (35.1) | 19 (38.0) | 0.755 |
| Proportion PCR negative conversion by day 10, n(%) | 28 (49.1) | 27 (54.0) | 0.615 |
| Number of patients with CT values data at both baseline and follow-upe | 15 | 15 | N/A |
| Change in CT-values from baseline, mean (SD) | 5.8 (5.3) | 4.1 (7.1) | 0.471 |
| Proportion with 50% reduction of SARS COV-2 viral load (CT-values) from baseline at day 6, n(%) | 5 (33.3) | 6 (40.0) | 0.705 |
| Proportion with 25% reduction of SARS COV-2 viral load (CT-values) from baseline at day 6, n(%) | 8 (53.3) | 6 (40.0) | 0.464 |
| Median (IQR) time in days to symptom clearance by day 10f | 3 (2–5) | 3 (2– 5) | 0.909 |
| Laboratory safety outcomes | |||
| Number of patients with ALT data at day 0 and 4 | 46 | 38 | N/A |
| Incident ALT > 40 IU at day4, n (%) | 4 (8.7) | 5 (13.2) | N/A |
| Incident elevated QTc interval | |||
| Male–number of participants | 39 | 37 | N/A |
| Incident elevated QTc > 450 ms | 1 (2.6) | 3 (8.1) | |
| Female–number of participants | 16 | 13 | N/A |
| Incident elevated QTc > 470 ms | 1 (6.3) | 0 | |
| Incident color vision loss/deficiency at day 4 | 0 | 0 | N/A |
PCR polymerase chain reaction, CT values cycle threshold values
aIntention-to-treat analysis but with early stopping at an estimated 37% (105) of required sample size of 284
bA participant was considered as having attained PCR negative conversion at first negative SARS COV-2 PCR test but without subsequent positive PCR test
cTime to viral load clearance was estimated in only those who had viral load clearance. Majority of patients were enrolled at day4 after first positive PCR tests. Only 20/104 (19.2%) had day 2 PCR test results
dCox proportional hazard regression model adjusting for age groups () and gender
eCT-values data is analyzed for only positive PCR tests at day 6, therefore, we expect less numbers here
fTime to symptom clearance was estimated in only participants who reported a symptom at baseline