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 | Â |
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 | Â |