summary
treatment
patients
method
baseline characteristics
risk of bias
references
adverse events AE leading to drug discontinuation hyperbilirubinemia related AE (TRAE) related SAE (TRSAE) serious adverse events A EFFACER PCR-negative (end of follow-up) clinical deterioration clinical improvement clinical improvement (14-day) clinical improvement (21-day) clinical improvement (28-day) clinical improvement (time to event analysis only) death D28 deaths deaths (time to event analysis only) emergency room observation for > 6 hours or hospitalization hospitalization hospitalization or death ICU admission mechanical ventilation Recovery (time to event analysis only) viral clearance viral clearance by day 14 viral clearance by day 7
overview
numeric
bar chart
forest plot
medians
figures
uncontrolled
O6
Study
Ref.
Design
studied treatment control treatment patients study risk of bias sample sizes
Results
Chaccour, 2020 NCT04390022 RCT ivermectin placebo COVID 19 outpatients, COVID-19 mild to moderate low 12/12 inconclusive inconclusive 8 % decrease in viral clearance ,viral clearance by day 7 (PE) with a high degree of certainty due to low risk of bias COPE – Coalition V, 2022 NCT04466540 RCT hydroxychloroquine placebo COVID 19 outpatients some concern 689/683 inconclusive inconclusive 23 % decrease in hospitalization (PE) with a moderate degree of certainty due to some concern in risk of bias TOGETHER (ivermectine), 2022 NCT04727424 RCT ivermectin placebo COVID 19 outpatients low 679/679 inconclusive inconclusive 10 % decrease in clinical deterioration (PE) with a high degree of certainty due to low risk of bias ACTION, 2021 NCT04332107 RCT azithromycin placebo COVID 19 outpatients some concern 171/92 inconclusive inconclusive 1 % increase in clinical improvement (14-day) (PE) with a moderate degree of certainty due to some concern in risk of bias The original primary outcome was changed given the lower risk of hospitalization and slower than anticipated enrollment. EPIC-HR, 2021 NCT04960202 RCT nirmatrelvir / ritonavir (Paxlovid) placebo COVID 19 outpatients low 1120/1126 conclusif demonstrated 88 % decrease in hospitalization or death (PE) with a high degree of certainty due to low risk of biassuggested 96 % decrease in deaths,death D28 with a high degree of certainty due to low risk of bias suggested 90 % decrease in hospitalization or death with a high degree of certainty due to low risk of bias suggested 88 % decrease in hospitalization or death with a high degree of certainty due to low risk of bias statistically significant 76 % increase in related AE (TRAE) with a high degree of certainty due to low risk of bias Based on laboratory studies only, Paxlovid is also expected to be active against Omicron and other variants. Fischer (all doses), 2021 NCT04405570 RCT molnupiravir placebo COVID 19 outpatients some concern 140/62 suggested suggested 13.5-fold increase in viral clearance ,viral clearance by day 7 with a moderate degree of certainty due to some concern in risk of bias Hinks (ATOMIC2), 2021 NCT04381962 RCT azithromycin standard of care COVID 19 outpatients some concern 147/148 inconclusive inconclusive 9 % decrease in hospitalization or death (PE) with a moderate degree of certainty due to some concern in risk of bias Lopez-Medina, 2021 NCT04405843 RCT ivermectin placebo COVID 19 outpatients some concern 200/200 inconclusive inconclusive 7 % increase in clinical improvement,clinical improvement (time to event analysis only) (PE) with a moderate degree of certainty due to some concern in risk of bias MOVe-OUT, 2021 NCT04575597 RCT molnupiravir placebo COVID 19 outpatients low 716/717 conclusif demonstrated 52 % decrease in hospitalization or death (PE) with a high degree of certainty due to low risk of biassuggested 51 % decrease in hospitalization with a high degree of certainty due to low risk of bias PATCH Cohort 1 (Amaravadi), 2021 NCT04329923 RCT hydroxychloroquine standard of care COVID 19 outpatients some concern 15/13 inconclusive PINETREE (GS-US-540-9012), 2021 NCT04501952 RCT remdesivir placebo COVID 19 outpatients low 292/292 conclusif demonstrated 87 % decrease in hospitalization or death (PE) with a high degree of certainty due to low risk of biassuggested 72 % decrease in hospitalization with a high degree of certainty due to low risk of bias PRINCIPLE, 2021 ISRCTN86534580 RCT azithromycin standard of care COVID 19 outpatients some concern 540/875 inconclusive inconclusive 8 % increase in clinical improvement,clinical improvement (time to event analysis only) (PE) with a moderate degree of certainty due to some concern in risk of bias inconclusive 6 % decrease in hospitalization (PE) with a moderate degree of certainty due to some concern in risk of bias Reis (Hydroxychloroquine) (TOGETHER), 2021 NCT04403100 RCT lopinavir/ritonavir placebo COVID 19 outpatients some concern 214/227 inconclusive Reis (Lopinavir-ritonavir) (TOGETHER), 2021 NCT04403100 RCT lopinavir/ritonavir placebo COVID 19 outpatients some concern 244/227 inconclusive Rodrigues, 2021 RCT azithromycin plus hydroxychloroquine placebo COVID 19 outpatients some concern 42/42 inconclusive TOGETHER, 2021 NCT04727424 RCT fluvoxamine placebo COVID 19 outpatients some concern 741/756 suggested suggested 36 % decrease in emergency room observation for > 6 hours or hospitalization (PE) with a moderate degree of certainty due to some concern in risk of bias BCN PEP-CoV-2-Study 2 (Mitja et al. Clin Infect Dis), 2020 NCT04304053 RCT hydroxychloroquine standard of care COVID 19 outpatients some concern 137/157 safety concern statistically significant 25.5-fold increase in adverse events with a moderate degree of certainty due to some concern in risk of bias statistically significant 177.2-fold increase in adverse events with a moderate degree of certainty due to some concern in risk of bias COVID-PEP Severity (Skipper), 2020 NCT04308668 RCT hydroxychloroquine control COVID 19 outpatients some concern 244/247 no results change in symptom severity over 14 days did not differ between the hydroxychloroquine and placebo groups (difference in symptom severity: relative, 12%; absolute, −0.27 points [95% CI, −0.61 to 0.07 points]; P = 0.117) COVID-PEP Severity (Skipper), 2020 NCT04308668 RCT hydroxychloroquine placebo COVID 19 outpatients some concern 244/247 safety concern statistically significant 1.8-fold increase in adverse events with a moderate degree of certainty due to some concern in risk of bias change in symptom severity over 14 days did not differ between the hydroxychloroquine and placebo groups (difference in symptom severity: relative, 12%; absolute, −0.27 points [95% CI, −0.61 to 0.07 points]; P = 0.117) IVERCORCOVID19 (Vallejos), 2020 NCT04529525 RCT ivermectin placebo COVID 19 outpatients low 250/251 inconclusive inconclusive 35 % decrease in hospitalization (PE) with a high degree of certainty due to low risk of bias Lenze (STOP COVID 1), 2020 NCT04342663 RCT fluvoxamine placebo COVID 19 outpatients some concern 80/72 conclusif demonstrated 93 % decrease in clinical deterioration (PE) with a moderate degree of certainty due to some concern in risk of bias Q-PROTECT (HCQ/AZI vs PLACEBO), 2020 NCT04349592 RCT hydroxychloroquine plus macrolides placebo COVID 19 outpatients some concern 152/152 safety concern inconclusive 14 % decrease in viral clearance ,viral clearance by day 7 (PE) with a moderate degree of certainty due to some concern in risk of bias statistically significant 45 % decrease in viral clearance by day 14 with a moderate degree of certainty due to some concern in risk of bias Roozbeh, 2020 IRCT20200403046926N1 RCT sofosbuvir and daclatasvir standard of care COVID 19 outpatients bias due to missing outcome data bias in measurement of the primary outcome bias in selection of the reported result
PE: primary endpoint; (a): to be demonstrated a result must be statistically significant on a primary endpoint (with multiplicity adjustment if necessary);
