Trial NCT04646109
Publication Okumus N, BMC Infectious Disea (2021) (published paper)
Dates: 2020-05-11 to 2020-09-02
Funding: Public/non profit (Afyonkarahisar Health Science University)
Conflict of interest: No

Methods
RCT
Blinding: Single blinded, no restrictions
Location : Multicenter / Turkey
Follow-up duration (days): 90
Inclusion criteria
  • 1. Patients who were hospitalised with a pre-diagnosis of "severe COVID-19 pneumonia" and thereafter diagnosis of COVID-19
    2. Confirmed microbiologically with PCR positivity in respiratory tract samples.
    3. Patients with at least one of the criteria below were accepted as patients with severe COVID-19 pneumonia:
    a. Presence of tachypnea ≥ 30/minute
  • SpO2 level < 90% in room air
  • PaO2/FiO2 <300 in oxygen receiving patient

  • b. Presence of specific radiological finding for COVID-19 in lung tomography (bilateral lobular, peripherally located, diffuse patchy ground glass opacities)

  • c. Mechanical ventilation requirement

  • d. Acute organ dysfunction findings
  • patients with SOFA (sepsis-related organ failure assessment) score >2
Exclusion criteria
  • 1. Children < 18 years old

  • 2. Pregnancy

  • 3. Active breast feeding

  • 4. Concurrent autoimmune disease

  • 5. Chronic liver or kidney disease

  • 6. Immunosuppression

  • 7. SNP mutation in MDR-1/ABCB1 gene and/or haplotypes and mutations of the CYP3A4 gene

  • 8. Patients with known ivermectin allergy
Interventions
Treatment
Ivermectin
200 mcg/kg enterally once daily for 5 days.
9 mg between 36–50 kg, 12mg between 51–65 kg, 15mg between 66–79 kg and 200 mcg/kg in > 80 kg
Control
Standard care

Participants
Randomized
participants :
Ivermectin=36
Standard care=30
Characteristics of participants
N= 66
Mean age : NR
40 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=58 Critical: n=2
Number of vaccinated participants: NR
Primary outcome
In the register
1. Gender Distribution of the Patients [ Time Frame: At the first day of the study ]
2. Age Distribution of the Patients [ Time Frame: At the first day of the study]
3. Percentage of Patients With Accompanying Diseases [ Time Frame: At the first day of the study]
4. Percentage of Patients With Baseline Clinical Symptoms [ Time Frame: At the first day of the study ]
5. Body Temperature Means of the Patients [ Time Frame: At the first day of the study]
6. Heart Rate Means of the Patients [ Time Frame: At the first day of the study]
7. Respiratory Rate Means of the Patients [ Time Frame: At the first day of the study]
8. Systolic and Diastolic Pressure Means of the Patients [ Time Frame: At the first day of the study]
9. Number of Participants With Clinical Response [ Time Frame: From starting to the end of ivermectin therapy (0 to the end of 5th day)]
10. Changes in Oxygen Saturation (Sp02) Values [ Time Frame: From starting to the end of ivermectin therapy (0 to the end of 5th day)]
11. Changes in the Ratio of Partial Pressure of Oxygen (Pa02) to Fraction of Inspired Oxygen (Fi02) (Pa02/Fi02) [ Time Frame: From starting to the end of ivermectin therapy (0 to the end of 5th day) ]
12. Changes in Serum Lymphocyte Counts [ Time Frame: From starting to the end of ivermectin therapy (0 to the end of 5th day)]
13. Changes in the Ratio of Polymorphonuclear Leukocyte Count to Lymphocyte Count (PNUL) [ Time Frame: From starting to the end of ivermectin therapy (0 to the end of 5th day) ]
14. Changes in Serum Ferritin Levels [ Time Frame: From starting to the end of ivermectin therapy (0 to the end of 5th day)]
15. Changes in Serum D-dimer Levels [ Time Frame: From starting to the end of ivermectin therapy (0 to the end of 5th day) ]
16. Genetic Examination of Haplotypes and Mutations That Cause Function Losing for Ivermectin Metabolism [ Time Frame: At the first day of ivermectin therapy (1st day)]
17. Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: At the first 5 days of study]
In the report
Clinical responses and drug side effects obtained in patients on the 5th day
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

Yes
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
High
General comment In addition to the pre-print and published article, the study registry (including outcome data) and protocol were used in data extraction and risk of bias assessment. The study was registered retrospectively but the protocol was dated prospectively. The trial used a quasi-randomized design.
This study was updated on April 07th, 2021, with data from the study registry.
On 12th of May, 2021, this study was updated based on the published report.