Trial IRCT20201003048904N2
Publication Abbasi F, 2021 (preprint)
Dates: 12/1/2020 to 4/30/2021
Funding: Public/non profit (Shiraz University of Medical Sciences, Bushehr University Medical Sciences, Faghihi Hospital and Shohadaye_Khalije_Fars Hospital.)
Conflict of interest: No

Methods
RCT
Blinding: single blinding
Location : Multicenter / Iran
Follow-up duration (days): *
Inclusion criteriaAdult patients, at least 20 years of age; admitted to the hospital for COVID-19 treatment; laboratory confirmed SARS-CoV-2 infection (nasal/throat swabs positive for SARS-CoV-2 by RT-PCR) or positive history of exposure to COVID-19 patients besides typical pattern of viral pneumonia on high-resolution CT and characteristic clinical manifestations.
Exclusion criteriaPatients who needed intubation or ICU admission at the presentation; had active malignancy or severe immune deficiency; taking spironolactone (or other mineralocorticoid blockers) and/or DPP4 inhibitors before hospital admission; had not signed the formal informed consent, refused taking medications, declined blood sampling, imaging or any kind of participation, expressed opposition to data collection or did not stay in the hospital for at least 3 days
Interventions
Treatment 1
Sitagliptin
Control
Standard care
Treatment 3
Spironolactone
Treatment 4
Sitagliptin+Spironolactone
Participants
Randomized
263 participants n1=66/ n2=87/ n3=50n4=60
Characteristics of participants
N=263
Mean age : 57.2
133 males
Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=0
Primary outcome
In the register
The blood oxygen saturation percentage is examined as an index of oxygenation status. first, third and fifth day of study
In the report
Survival HR reported for older age, BMI>30, comorbidities and co-interventions in all intervention groups combined versus placebo.
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated

NR
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 This trial is pending contact with authors. No review-specific outcomes were able to be extracted.
In addition to the pre-print article, the trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary outcome in the article (clinical improvement of the patients in the hospital as measured on an eight-point numerical scale) did not reflect that in the registry (blood oxygen saturation). The trial achieved its target sample size.