Methods |
Trial design: double‐blind RCT with 2 parallel arms
Type of record: trial register entry
Sample size: 750
Setting: outpatient
Country: Argentina
Language: English
Number of centres: NR
Study purpose (treatment, prevention): prevention
Trial registration number: NCT04894721
Date of registration: 20 May 2021
|
Participants |
-
Inclusion criteria
Age > 18 years
Women of childbearing age with negative pregnancy test
In close contact group or epidemiological nexus of a positive COVID‐19 case
Able to understand and grant informed consent
RT‐PCR with a negative result
-
Exclusion criteria
Hypersensitivity or allergy to any component of the drug under evaluation
Age < 18 years
Use of immunosuppressants (including systemic corticosteroids) in last 30 days
Pregnant or lactating
Other acute infectious diseases
Autoimmune disease or chronic decompensated diseases, or both
Received a vaccine for COVID‐19 (1 or 2 doses) or who have received ivermectin (prior to 30 days of the study) or who are participating in another COVID‐19 prophylaxis study
|
Interventions |
|
Outcomes |
|
Notes |
Reason for awaiting classification: study completed, but results not published yet
Recruitment status: completed
Prospective completion date: October 2021, study completed
Planned completion date more than 6 months ago: no
Date last update posted: 7 December 2021
Sponsor/funding: Ministry of Public Health, Argentina
|