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Table 2 Summary of clinical studies: lopinavir/ritonavir

From: Repurposed pharmacological agents for the potential treatment of COVID-19: a literature review

Study

Study design (number of participants)

Study arms (number of participants)

Endpoints

Results

Cao et al. LOTUS [52]

Randomised, open-label, controlled trial (n = 199)

1. Standard of care plus lopinavir/ritonavir 400 mg/100 mg twice a day for 14 days (n = 99)

2. Standard of care (n = 100)

Primary:

Time to clinical improvement

Secondary:

Day 28 mortality; clinical improvement on day 7, 14, 28; ICU length of stay; duration of invasive mechanical ventilation; oxygen support in days; hospital stay in days; time from randomization to death

No significant difference in time to clinical improvement between lopinavir/ritonavir and standard of care (median time in days, 15 vs 16)

28-day mortality lower in lopinavir/ritonavir than in standard of care (19.2% vs 25%)

Shorter ICU stays with lopinavir/ritonavir (median time in days, 6 vs 11)

Shorter duration from randomisation to hospital discharge with lopinavir/ritonavir (median time in days, 12 vs 14)

Higher percentage of patients with clinical improvement at day 14 with lopinavir/ritonavir (45.5% vs 30%)

No significant differences

for duration of oxygen therapy, duration of hospitalization, time from randomization to death

Yan et al. [54]

Retrospective cohort study (n = 120)

1. Lopinavir/ritonavir 400 mg/100 mg twice a day for a median duration of 10 days (n = 78)

2. Systemic corticosteroids (n = 54)

Time from symptom onset to SARS-CoV-2 negativity

The lack of lopinavir/ritonavir treatment was a risk factors for prolonged SARS-CoV-2 shedding

Li et al. [55]

Randomised, partially blinded, controlled trial (n = 86)

1. Lopinavir/ritonavir 200 mg/50 mg orally twice per day for 7 to 14 days (n = 34)

2. Arbidol 200 mg three times per day for 7 to 14 days (n = 35)

3. No antiviral treatment (n = 17)

Primary:

Rate of positive to negative conversion of SARS-CoV-2 from initiation of treatment to day 21

Secondary:

Rate of positive to negative

conversion of SARS-CoV-2 at day 14; rate of antipyresis; rate of cough alleviation; improvement

rate of chest CT at days 7 and 14; rate of deterioration of clinical status during time of study

No statistically significant difference in mean time for positive to negative conversion (9.0 days in lopinavir/ritonavir, 9.1 days in arbidol, 9.3 days in the control group)

Positive to negative conversion after 14 days was 85.3% in lopinavir/ritonavir, 91.4% in arbidol, 76.5% in the control group

No statistically significant difference in other secondary endpoints