Trial IRCT20190804044429N4
Publication Azizi H, nt Immunopharmacol (2021) (published paper)
Dates: 2020-11-01 to 2021-04-30
Funding: Public/non profit (Mazandaran University of Medical Sciences)
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Single center / Iran
Follow-up duration (days): 11
Inclusion criteria
  • Hospitalized COVID-19 patients
  • over 18 years
  • COVID-19 symptoms beginning within the last 14 days, according to the WHO proposed definition confirmed by RT-PCR or chest CT scan
Exclusion criteria
  • A history of pentoxifylline use
  • cerebral or ocular bleeding
  • renal impairment (GFR < 30 ml per minute)
  • hepatic impairment (Child-Pugh C)
  • hypersensitivity to pentoxifylline
  • breastfeeding and pregnant women
Interventions
Treatment
Pentoxifylline
400 mg orally three times a day for 10 days
Control
Placebo

Participants
Randomized
participants :
Pentoxifylline =52
Placebo=50
Characteristics of participants
N= 102
Mean age : NR
25 males
Severity : Mild: n=* / Moderate: n=* / Severe: n=* Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
1. Clinical response to therapeutic regimen by respiratory rate; 2. Clinical response to therapeutic regimen by blood oxygen saturation; 3. Clinical response to therapeutic regimen by fever recovery; 4. therapeutic regimen safety; 5. Clinical response to therapeutic regimen by LDH level reduction; 6. Clinical response to therapeutic regimen by CRP level reduction; 7. Clinical response to therapeutic regimen by lymphocyte count recovery
In the report
Clinical response of patients, which was evaluated using an eight-point ordinal scale. A score <3 was considered as a response to treatment
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
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
Some concerns
General comment In addition to the published article, the study registry was used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan was available. The study achieved the target sample size specified in the trial registry (registry: 60, report: 102). There is no change from the trial registration in the intervention and control treatments. The primary outcome reported in the publication (clinical improvement according to score <3 on the ordinal scale) does not reflect the seven primary outcomes listed in the registry (clinical response by respiratory rate, by blood oxygen saturation, by fever recovery, by LDH level reduction, by CRP level reduction, by lymphocyte count recovery, and safety).