Study characteristics |
Methods |
Trial design: open‐label RCT with 4 parallel arms, the 3 intervention arms were pooled for this review
Type of publication: journal publication
Setting: inpatient
Recruitment dates: July to December 2020
Country: Brazil
Language: English
Number of centres: 1
Study purpose (treatment, prevention): treatment
Trial registration number: NCT04431466
Date of registration: 16 June 2020
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Participants |
Number of participants (randomized/analyzed): 32/31
Age (mean): overall 49 (SD 14.6) years
Males, n: overall 17 (45%)
Severity of condition according to study definition: hospitalized, mild clinical symptoms
Severity of condition according to WHO scale: unclear; available information: minimum category 4, 20% in category 5
Co‐morbidities: NR
Virus detection performed at baseline (test‐positive at baseline): RT‐PCR (100%)
Inclusion criteria: diagnosis of infection by SARS‐CoV‐2 by symptoms of acute respiratory tract infection (sudden onset of ≥ 1 of the following: cough, fever, shortness of breath) and biomolecular diagnosis of SARS‐CoV‐2 infection or any acute respiratory disease AND biomolecular diagnosis of SARS‐CoV‐2 infection or severe acute respiratory infection (fever and ≥ 1 sign/symptom of respiratory disease, e.g. cough, fever, shortness of breath); need of hospitalization; biomolecular diagnosis of SARS‐CoV‐2 infection; Eastern Cooperative Oncology Group Performance Status score 0 to 1; National Early Warning Score 0–4; ability to understand and consent to participate in this clinical trial, manifested by signing the informed consent form.
Exclusion criteria: inability to ingest study drug orally through spontaneous ingestion or use of enteral tubes; risk to participant in the trial judged by physician, based on patient history, clinical observation, laboratory test findings, ECG examination; known hypersensitivity to the components of the drugs used during the study; women in pregnancy or breastfeeding; bodyweight < 15 kg; estimated glomerular filtration rate < 30 mL/minute; AST or ALT > 5 times the upper limit of normality; refusal to participate or to sign the informed consent form
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Interventions |
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Details of intervention
Type and dose: ivermectin 0.1 mg/kg, 0.2 mg/kg, and 0.4 mg/kg cumulative over 72 hours, unclear frequency scheme (pooled)
Route of administration: oral
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Treatment details of control group
Concomitant therapy: standard of care including thromboprophylaxis, steroids, antibiotics administered in both study arms, but unbalanced between groups
Duration of follow‐up: 28 days
Treatment cross‐overs: none
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Outcomes |
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Notes |
Date of publication: 9 March 2021
Sponsor/funding: Federal University of Sao Carlos, Brazil
Correspondence with the author team: author request sent (details of intervention, especially deviations between protocol and publication); no response received from the author
Information on ethics votum: name of responsible ethics committee, reference number of proposal, and votum reported
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