Covid-19 living Data

Pentoxifylline vs Standard care/Placebo (RCT)

Hospitalized patients

FOREST PLOTS -2021-11-05

Studies description

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
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 avalaible	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).

Trial *
Publication Maldonado V, INT IMMUNOPHARMACOL (2020) (published paper)
Dates: 2020-07-01 to 2020-08-31
Funding: No specific funding (None)
Conflict of interest: No

Methods
	RCT
	Location : Single center / Mexico Follow-up duration (days): *
Inclusion criteria	Pneumonia suspected of being caused by SARS-COV2 with clinical symptoms and signs such as fever, fatigue, dry cough, anorexia, myalgia, dyspnea, sputum production, dysgeusia, and anosmia infiltrates in chest imaging studies (plain radiography or tomography) confirmation of SARS-CoV-2 infection by viral PCR signed informed consent for receiving their primary treatment and pentoxifylline if selected to be included in the pentoxifylline group
Exclusion criteria	Pregnant or lactating patients those who did not wish to participate in the study or had an allergy, intolerance, or contraindication for pentoxifylline.
Interventions
	Treatment Pentoxifylline 400 mg orally 3 times a day until discharge
	Control Standard care
Participants
	Randomized participants : Pentoxifylline =36 Standard care=18
	Characteristics of participants N= 54 Mean age : NR 21 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=*
Primary outcome
	In the register NR
	In the report NR
Documents avalaible	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	*
General comment	The overall follow-up time period for this study, as well as the appropriate timepoints for outcomes, could not be determined at the time of extraction. This study is pending contact with authors. Only the available version of the pre-print article was used for in data extraction and risk of bias assessment. Neither the trial protocol not the registry were available at the time of data extraction. No target sample was prespecified. 1 patient withdrew because of adverse event (abdominal pain), 15 additional patients had incomplete data.