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Table 2 Clinic trials investigating the efficacy of hydroxychloroquine for COVID-19

From: FDA efficiency for approval process of COVID-19 therapeutics

Study

Primary Outcome

Strengths

Weaknesses

Gao et al. [45]

- Compared to control treatment, more than 100 patients treated with chloroquine had superior inhibition of pneumonia exacerbation, negative seroconversion, and a shortened disease course

- Rapid action to organize a clinical trial for a novel disease based on in vitro data

- Reported both virologic and clinical outcomes

- Indicated more trials were needed

- Clinical trial results reported as part of a news briefing by the State Council of China rather than in a peer reviewed journal

Gautret et al. [68]

- Statistically significant more patients treated with hydroxychloroquine (14/20 = 70%) had negative nasopharyngeal PCR for SARS-CoV-2 by day 6 post inclusion compared to controls (2/16 = 12.5%) (p = 0.001)

- First clinical evidence on the effect of hydroxychloroquine on the nasopharyngeal clearance of SARS-CoV-2 with reported mean duration of viral shedding to be 20 days

- Indicated more trials were needed to investigate the clinical effects of hydroxychloroquine

- Non-randomized

- Wide range of severity of illness

- Combination therapy with azithromycin in six patients

- Small sample size (N = 36)

- 6 of 26 patients in HCQ treatment group were lost to follow up including ICU admission (3), death (1), leaving hospital (1), and cessation of treatment due to nausea (1)

Chen et al. [69]

- There was no statistically significant difference between the hydroxychloroquine group (86.7%) and control group (93.3%) in day 7 negative nucleic acid throat swab for SARS-CoV-2 in hospitalized patients with COVID-19 (p > 0.05)

- Randomization of participants

- Reported clinical endpoints in addition to virologic clearance

- Small sample size (N = 30)

Tang et al. [70]

- There was no significant difference in negative conversion of SARS-CoV-2 by 28 days between hydroxychloroquine and the standard of care group in patients with mild to moderate COVID-19 with higher adverse events in the hydroxychloroquine group

- Randomization

- Increased sample size (N = 150)

- Included patients with mainly mild to moderate disease (148/150)

- Intention to treat statistical analysis

 

Horby et al., [71] (RECOVERY Trial)

- There was no statistically significant difference in mortality between the hydroxychloroquine arm and the standard of care arm

- Enrollment suspended from hydroxychloroquine arm on 6/5/20

- Randomized, multiarmed clinical trial

- Large sample size with 1542 patients in the hydroxychloroquine arm

- Primary endpoint of 28-day mortality

 

Pan et al., [72]

(SOLIDARITY Trial)

- There was no statistically significant effect on hospitalized patients with COVID-19 including overall mortality

- Hydroxychloroquine arm dropped from trial on 6/17/20

- Randomized, international clinical trial

- Large sample size with 954 patients in the hydroxychloroquine arm

- Investigated hospitalized population

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