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Table 4 Comparison of primary and secondary outcomes

From: Safety and efficacy of hydroxychloroquine for treatment of non-severe COVID-19 among adults in Uganda: a randomized open label phase II clinical trial

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

  1. PCR polymerase chain reaction, CT values cycle threshold values
  2. aIntention-to-treat analysis but with early stopping at an estimated 37% (105) of required sample size of 284
  3. bA participant was considered as having attained PCR negative conversion at first negative SARS COV-2 PCR test but without subsequent positive PCR test
  4. 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
  5. dCox proportional hazard regression model adjusting for age groups () and gender
  6. eCT-values data is analyzed for only positive PCR tests at day 6, therefore, we expect less numbers here
  7. fTime to symptom clearance was estimated in only participants who reported a symptom at baseline
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BMC Infectious Diseases

ISSN: 1471-2334

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