Research Square
| Treatments | |
| Studied treatment |
ivermectin soc
Ivermectin (Enteral solution at 200 microgr/kg/day (9mg between 36-50 kg, 12mg between 51-65 kg, 15mg between 66-79 kg and 200 microgram/kg in > 80 kg) for 5 days |
| Control treatment |
Soc
Favipiravir (2x1600mg loading dose followed by 2x600mg maintenance dose, po, total 5 days); Hydroxychloroquine (2x400mg loading dose followed by 2x200mg, po, 5 days);Azithromycin (500mg first day loading dose, followed by 250mg/day, po, total 5 days) |
| Remarks about treatments | |
| Patients | |
| Patients | Age ≥ 18y; RT-PCR positive, severe COVID-19 patients |
| Details/remarks about patients | |
| Method | |
| Blindness | single blind |
| Primary endpoint(s) | multiple |
| Localisation | 4 centres, Turkey |
| Inclusion period | May-September 2020) |
| Follow-up duration | 5 days |
| Sponsor | |
| Remark about method | described as crossover assignment and several inconsistencies in the description of endpoints in clinicalTrials.gov |
| Remarks | results up-dated with pre-print |
| Endpoint
(lib. in paper) |
Subroup | Relative effect | Trt. better when | LoD | x/n | x/n | ARR | NNT | rate or median | Δ | comment | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ivermectin vs. control | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| clinical improvement (Clinical improvement at 5 days) | 1.51 [0.54; 4.24]C | >1 | 14/30 (46.7%) | 11/30 (36.7%) | 10.00% [-14.82; 34.82] | 10 | -9 vs -9 | 0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| deaths (death (3 month)) | 0.58 [0.18; 1.91]C | <1 | 6/30 (20.0%) | 9/30 (30.0%) | -10.00% [-31.77; 11.77] | -10 | -9 vs -9 | 0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
LoD: level of demonstration ( demonstrated, suggested, inconclusive, safety concerns);
C: treatment effect calculated from numbers of events and sample sizes: ARR: absolute risk reduction; NNT: number needed to treat; PE: primary endpoint; S: safety endpoint;
Okumus N et al. Evaluation of the Effectiveness and Safety of Adding Ivermectin to Treatment in Severe COVID-19 Patients Research Square 10.21203/rs.3.rs-224203/v1 [PMID: ]