Study characteristics |
Methods |
Trial design: open‐label RCT with 2 parallel arms
Type of publication: preprint
Setting: inpatient
Recruitment dates: March to June 2020
Country: Pakistan
Language: English
Number of centres: 1
Study purpose (treatment, prevention): treatment
Trial registration number: NCT04392713
Date of registration: 19 May 2020
|
Participants |
Number of participants (randomized/analyzed): 100/86
Age (mean): overall 41 (SD NR) years
Males, n: overall 73 (85%)
Severity of condition according to study definition: hospitalized, mild‐to‐moderate symptoms
Severity of condition according to WHO scale: 4 to 5
Co‐morbidities: diabetes, hypertension
Virus detection performed at baseline (test‐positive at baseline): RT‐PCR (100%) (relevant population 100% test‐positive)
Inclusion criteria: provision of signed and dated informed consent form; stated willingness to comply with all study procedures and admission for the duration of the study; male or female; aged 15–65 years; in good general health with no or mild‐to‐moderate symptoms of COVID‐19; PCR positive for SARS‐CoV‐2; ability to take oral medication
Exclusion criteria: SARS‐CoV‐2 infection with severe symptoms, likely due to cytokine release syndrome; uncontrolled co‐morbidities, and immunocompromised states; history of ivermectin allergy; receiving CYP 3A4‐inhibitors or ‐inducers
|
Interventions |
-
Details of intervention
-
Treatment details of control group
Concomitant therapy: standard of care including vitamin C, vitamin D3, paracetamol administered in both study arms; unclear whether standard of care included chloroquine as stated in the protocol
Duration of follow‐up: 28 days
Treatment cross‐overs: none
|
Outcomes |
|
Notes |
Date of publication: 5 February 2021
Sponsor/funding: departmental resources
Correspondence with the author team: author request sent (publication status, outcome data including number of participants and events for participants with negative RT‐PCR at 7 and 14 days); no response received from the author
Information on ethics votum: name of responsible ethics committee, reference number of proposal, and votum reported
|