Covid-19 Living Data

Trial IRCT20201003048904N2
Publication Abbasi F, J Endocr Soc (2022) (published paper)
Dates: 2020-12-01 to 2021-04-30
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): 40
Inclusion criteria	Adult 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 criteria	Patients 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 Sitagliptin 100 mg orally once a day for 5 days Spironolactone 100 mg orally once a day for 5 days SITA+SPL 100 mg + 100 mg orally once a day for 5 days
	Control Standard care
Participants
	Randomized NR Analyzed 263 participants Sitagliptin=66 Spironolactone=50 SITA+SPL=60 Standard care=87
	Characteristics of participants N= 263 Mean age : NR 133 males Severity : Mild: n=* / Moderate: n=* / Severe: n=* Critical: n=0 Number of vaccinated participants: NR
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 Clinical improvement of the patients in the hospital as measured on an eight-point numerical scale ranging from no limitation of activities (score 1) to death (score 8)
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Yes
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. This study was updated on May 11th, 2022 with data from the peer-reviewed article. No data was extractable for our NMA outcomes.