Okumuş , 2020 NCT04646109   randomized controlled trial

ivermectin vs. standard of care COVID-19 severe or critically MA: ivermectin

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

Risk of bias (ROB 2.0 for randomized trials )

Bias Risk of bias Remark
bias arising from the randomization processhighThey were randomized to the study and control group, respectively. Single numbered patients were accepted as study group and double numbered patients as control group
bias due to deviations from intended interventionshighopen label
bias due to missing outcome datahigh
bias in measurement of the primary outcomesome concernopen label
bias in selection of the reported resultsome concern
Overall high

Results

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>114/30 (46.7%)11/30 (36.7%)10.00% [-14.82; 34.82]10-9 vs -90
deaths
(death (3 month))
0.58 [0.18; 1.91]C<16/30 (20.0%)9/30 (30.0%)-10.00% [-31.77; 11.77]-10-9 vs -90

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;

References

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: ]

Okumus N et al. et al. Evaluation of the effectiveness and safety of adding ivermectin to treatment in severe COVID-19 patients BMC Infect Dis 10.1186/s12879-021-06104-9 [PMID: 33947344]

Links

Linked figures